Dental CariesNCT05409625
3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression
A study testing Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark), Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1) and X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental) in people with Dental Caries, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of this study is to investigate whether the 3D scanner and accompanying software, as well as the transillumination method, can identify changes in primary caries lesions in caries-active patients, where selected lesions achieve a higher degree of plaque control than others over an 8-month period. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark), Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1) and X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental)
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2021to 19 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically healthy young adult patients (18-30 years old) where individuals must have ≥ 20 teeth.
- Two or more active caries lesions
Who cannot join
- Patients with impaired salivary secretion
- Patients with chronic medical diseases.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Odontology, University of Copenhagen
Copenhagen, 2200
About this study
The objective of this study is to investigate whether the 3D scanner and accompanying software, as well as the transillumination method, can identify changes in primary caries lesions in caries-active patients, where selected lesions achieve a higher degree of plaque control than others over an 8-month period.
The working hypothesis of this study is that the two methods, scanning and transillumination, are as good as the traditional method (clinical examination complemented by radiographs) to assess whether caries lesions are progressing, stable or regressing. Progression, stability or regression of selected caries lesions are thus the endpoint, and the rationale is to investigate whether more objective measures can replace/supplement a subjective method to assess progression, stability or regression of caries lesions.
Read the detailed description
Caries is a non-infectious disease of the hard tissues of the teeth that occurs with very high prevalence around the world. The aetiology and pathogenesis of the disease are well understood. Bacterial accumulation on the teeth (dental plaque) concomitant with the ingestion of fermentable carbohydrates promotes acid production deep within the plaque, which progressively demineralizes the underlying hard dental tissue. Caries thus involves mineral loss from the first crystal disintegrating (not clinically identifiable) through gradually increased demineralization, with the mineral loss being identified early by the tooth tissue changing colour, through the physical appearance of a fracture (cavity) in the tooth, to the complete damage of the tooth. Demineralization can be halted or controlled by daily brushing with fluoride toothpaste, provided that brushing, possibly supplemented with flossing, is carried out as demonstrated by dentists or dental hygienists. Adding professional cleaning, i.e. plaque removal with rotary brushes and flossing and performed by dentists/ dental hygienists or clinic assistants, e.g. once a month, can ensure that the lesion is stopped if daily home dental care is not optimal. If caries has occurred, it can be treated non-operatively or surgically, complemented by risk-related initiatives.
Caries can develop in relation to previously placed fillings. This is referred to as secondary caries. In contrast, the term primary caries is used for caries located on unfilled/restored areas of the tooth or its root surfaces. Whether primary or secondary, caries lesions' severity is classified as superficial, moderate or extensive. The last two diagnoses usually require operative treatment, i.e. a filling, or root canal treatment or extraction.
Caries is detected and diagnosed using a number of methods, the most common being a clinical visual/tactile examination of the teeth, complemented by radiographs. However, this method is highly subjective, and thus with large variation among dentists and dental hygienists, resulting in different treatment strategie. In addition, radiographs lack sensitivity in terms of detection of the initial caries lesions.
Researchers have therefore developed various devices and methods for a more objective modulation of mineral loss, including monitoring of individual caries lesions. Perhaps best known is the QLF (Quantitative Light Fluorescence) system, which uses fluorescence measurements of the tooth's response to demineralization. The latest technology using fluorescence for caries detection and classification is the intraoral 3D scanner with the integrated automated caries registration system, which has been developed and now for a few years has been tested in both in vitro and in vivo studies at the Department of Odontology of the University of Copenhagen (OI).
The technique is based on the fact that healthy and demineralized tooth tissue absorbs the blue-violet light (wavelength ~415 nm) and emits back fluorescent light with different light intensities, from bright green to brownish to red. In terms of detection and classification of caries lesions on occlusal surfaces, the scanner has overall a better reproducibility and a comparable accuracy expressed through sensitivity and specificity compared to a combination of the clinical and radiological examination.
Another method that has been widely investigated for the detection of initial proximal (between teeth) and occlusal caries lesions, without the use of ionizing radiation, is transillumination with near-infrared light (wavelength ~780 nm). In the transillumination method, the light is transmitted through the dental tissue. The caries lesions appear dark, like shadows, due to the scattering and absorption of the light in the porous demineralized tissue. In contrast, the healthy, transparent enamel tissue appears brighter as light penetrates this tissue with very low light scatter and almost no light absorption. This method is used by the intraoral camera "DIAGNOcam" (KaVo, Biberach, Germany) and has also been investigated by researchers from the Department of Odontology at the University of Copenhagen and 3Shape (3Shape TRIOS A/S, Copenhagen, Denmark) for implementation in the 3D intraoral scanner system. This has shown improved sensitivity in detecting initial approximal caries lesions that can be treated with preventive, non-operative methods.
One of the areas that remain to be investigated regarding the usefulness of the 3D scanner and transillumination camera as a caries diagnostic method is the monitoring of caries lesions between two or more examinations in the clinic, including how the systems respond to lesions that have received intensive treatment to stop their progression.
Method:
18-30-year-old young adults in Denmark with high caries activity. Potential participants are found by advertising for caries-active patients in the daily press, on the OI website or an announcement board at the OI.
When contacting a potential participant, information is provided about the study, in addition to what is stated in the advertisement, on the website or on announcement boards. After that the a clinical screening is conducted.
Participants (n ~33) are offered common caries prevention initiatives: improved self-care, toothbrush instruction using 1450 ppm fluoride toothpaste, dietary advice and topical fluoride treatment. In addition, selected superficial caries lesions on individual participants will be professionally cleaned once a month.
Study participants will receive dental check-ups at shorter intervals (approximately every 1.5 months) compared to standard treatment.
Participants with lesions requiring restorative treatment (media/profound lesions) or with teeth that must be extracted due to caries will be treated at the OI according to the usual rules.
A traditional clinical and radiological examination also includes the diagnosis of other pathological conditions of the oral cavity, which, if identified, will be treated at the OI, according to the usual rules, or the participant will be referred to a private dentist. Other diseases of the teeth and supporting tissues likely to be diagnosed in 18- to 30-year-olds are gingivitis, erosions and wisdom teeth which only partially emerge into the oral cavity (dentis retentus).
The examination shall be carried out at the Department of Odontology, University of Copenhagen (OI) First visit (Baseline) i) Relevant medical history. ii) Records: tooth and filling status (chart), as well as clinical plaque and gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
iii) X-rays: 2 BW (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental) with special holders for reproducible images.
iv) Dental cleaning and professional plaque removal, including flossing. v) 3D scanning vi) Transillumination method vii) ICDAS (International Caries Detection and Assessment System) registration viii) Treatment plan. ix) Treatment. Second visit (1.5 months) 3D intraoral scanning and ICDAS registration. Third visit (3 months) As at baseline, but no radiographs (BW). Fourth visit (~6 months) 3D intraoral scan and ICDAS registration. Fifth visit (8 months) As at 1st visit
In addition, participants will need to come a number of times to have their caries lesions that require restorative treatment treated.
At each visit, also when lesions are treated with fillings, polishing of selected lesions will be performed.
Monitoring plan The monitoring plan will be carried out in accordance with the standard procedures for clinical research at the Department of Odontology, University of Copenhagen.
Dental student Maria K. Riis will be responsible for daily data handling, secure data archiving, and recruitment of study participants.
Staff will be responsible for the overall monitoring of the study. This person (monitor) will soon be appointed by the Department of Odontology and will be responsible for a monthly check of the progress of the study, including the following parameters:
- Verification of the presence of the consent form.
- Verification that participants meet inclusion and exclusion criteria.
- Verification of data collected versus source data.
- Compliance with the protocol and documentation of any deviations
The reason for selecting participants aged 18 to 30 years is that they are more likely to have primary caries lesions (which is the focus area) than secondary caries lesions. In addition, other dental and oral diseases requiring treatment, such as extensive tooth wear, are less likely to be found during the traditional clinical and radiological examination conducted for the study in 18- to 30-year-olds compared to older individuals.
In addition, patients with chronic medical diseases or impaired salivary secretion are excluded as they are expected to have more extensive dental problems, which are not the focus of this study.
Publication of results The study protocol will be registered at www.ClinicalTrials.gov. The study results will be published in international scientific journals under the terms of the research agreement (09.01 Research collaboration agreement CPH (Copenhagen) University), to which this document is Appendix 2. This applies to negative, positive or inconclusive results. If contrary to expectations, publication in national/international journals is unsuccessful, the investigators will ensure, under the terms of the research agreement (09.01 Research collaboration agreement CPH University), that the data are published on the department's website. The research agreement (09.01 Research collaboration agreement CPH University) states that 3Shape can request that manuscript submission be postponed by up to three (3) months from the date of receipt, provided 3Shape proves that the postponement is important for 3Shape's prospects of acquiring intellectual property rights protection of the knowledge that the University has. The disclosure of knowledge shall always be made in compliance with the obligation of professional secrecy. The research agreement (09.01 Research collaboration agreement CPH University) states that 3Shape will use the anonymized clinical data for product development, regulatory and commercial activities related to 3Shape's products.
- Conditions
- Dental Caries
- Being tested
- Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark), Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1), X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental), Oral cleaning
- Keywords
- 3D Scanner, Fluorescence, Transillumination, Dental Caries, Intraoral Scanner
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark)Device
Intraoral scanner which is able to generate a 3D-model of the teeth and is being used for caries detection.
Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1)Device
Intraoral camera used for caries detection in the occlusal and proximal surfaces.
X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental)Device
X-ray device used for caries detection. Two radiographs (bitewings) are taken, one in each side.
Oral cleaningProcedure or surgery
Removal of tartar and plaque. Tartar removal done at baseline and the fifth visit, but only on selected teeth at the second, third and fourth visit. Regular cleaning with a toothbrush done at all visits.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Experimental | Participants aged between 18 and 30 years old without chronic diseases but with two caries lesions or more Receives: Device: Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark); Device: Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1); Device: X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental); Procedure: Oral cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: Baseline
2nd Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 1.5 months after baseline
3rd Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 3 months after baseline
4th Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 6 months after baseline
5th Scanner caries score
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
Measured: 8 months after baseline
1st NIR (Near-Infrared) caries score
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions.
(Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
Measured: Baseline
2nd NIR (Near-Infrared) caries score
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions.
(Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
Measured: 8 months after baseline
1st X-ray caries score
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
Measured: Baseline
2nd X-ray caries score
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
Measured: 8 months after baseline
1st Clinical ICDAS score
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
Measured: Baseline
2nd Clinical ICDAS score
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
Measured: 1.5 months after baseline
3rd Clinical ICDAS score
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
Measured: 3 months after baseline
4th Clinical ICDAS score
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
Measured: 6 months after baseline
5th Clinical ICDAS score
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
Measured: 8 months after baseline
1st Caries activity assessment score
The activity of the clinically identified caries lesions (active/arrested) will be based on:
Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1).
Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
Measured: Baseline
2nd Caries activity assessment score
The activity of the clinically identified caries lesions (active/arrested) will be based on:
Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1).
Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
Measured: 1.5 months after baseline
3rd Caries activity assessment score
The activity of the clinically identified caries lesions (active/arrested) will be based on:
Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1).
Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
Measured: 3 months after baseline
4th Caries activity assessment score
The activity of the clinically identified caries lesions (active/arrested) will be based on:
Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1).
Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
Measured: 6 months after baseline
5th Caries activity assessment score
The activity of the clinically identified caries lesions (active/arrested) will be based on:
Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1).
Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
Measured: 8 months after baseline
1st Clinical plaque score
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
Measured: Baseline
2nd Clinical plaque score
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
Measured: 1.5 months after baseline
3rd Clinical plaque score
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
Measured: 3 months after baseline
4th Clinical plaque score
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
Measured: 6 months after baseline
5th Clinical plaque score
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
Measured: 8 months after baseline
1st Clinical gingiva score
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Measured: Baseline
2nd Clinical gingiva score
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Measured: 1.5 months after baseline
3rd Clinical gingiva score
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Measured: 3 months after baseline
4th Clinical gingiva score
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Measured: 6 months after baseline
5th Clinical gingiva score
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Measured: 8 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Oct 2021
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim R. Ekstrand, ph.d, Study chair, Institute of Odontology, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409625
- Sponsor's protocol ID
- Protocol MKR
- Status last verified
- Jul 2025
- First submitted
- 16 Dec 2021
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michou S, Benetti AR, Vannahme C, Hermannsson PG, Bakhshandeh A, Ekstrand KR. Development of a Fluorescence-Based Caries Scoring System for an Intraoral Scanner: An in vitro Study. Caries Res. 2020;54(4):324-335. doi: 10.1159/000509925. Epub 2020 Oct 14.
PubMed 33053552Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
PubMed 25740856Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
PubMed 28540937Bellini HT, Arneberg P, von der Fehr FR. Oral hygiene and caries. A review. Acta Odontol Scand. 1981;39(5):257-65. doi: 10.3109/00016358109162287.
PubMed 7039213Lussi A, Hibst R, Paulus R. DIAGNOdent: an optical method for caries detection. J Dent Res. 2004;83 Spec No C:C80-3. doi: 10.1177/154405910408301s16.
PubMed 15286128de Josselin de Jong E, Sundstrom F, Westerling H, Tranaeus S, ten Bosch JJ, Angmar-Mansson B. A new method for in vivo quantification of changes in initial enamel caries with laser fluorescence. Caries Res. 1995;29(1):2-7. doi: 10.1159/000262032.
PubMed 7867045LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Scanning and Transillumination vs Conventional Examination to Assess Caries Progression, Stability or Regression
- ClinicalTrials.gov ID
- NCT05409625
- Acronym / sponsor ID
- Protocol MKR
- Conditions
- Dental Caries
- Keywords
- 3D Scanner, Fluorescence, Transillumination, Dental Caries, Intraoral Scanner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate whether the 3D scanner and accompanying software, as well as the transillumination method, can identify changes in primary caries lesions in caries-active patients, where selected lesions achieve a higher degree of plaque control than others over an 8-month period.
The working hypothesis of this study is that the two methods, scanning and transillumination, are as good as the traditional method (clinical examination complemented by radiographs) to assess whether caries lesions are progressing, stable or regressing. Progression, stability or regression of selected caries lesions are thus the endpoint, and the rationale is to investigate whether more objective measures can replace/supplement a subjective method to assess progression, stability or regression of caries lesions.
Detailed description
Caries is a non-infectious disease of the hard tissues of the teeth that occurs with very high prevalence around the world. The aetiology and pathogenesis of the disease are well understood. Bacterial accumulation on the teeth (dental plaque) concomitant with the ingestion of fermentable carbohydrates promotes acid production deep within the plaque, which progressively demineralizes the underlying hard dental tissue. Caries thus involves mineral loss from the first crystal disintegrating (not clinically identifiable) through gradually increased demineralization, with the mineral loss being identified early by the tooth tissue changing colour, through the physical appearance of a fracture (cavity) in the tooth, to the complete damage of the tooth. Demineralization can be halted or controlled by daily brushing with fluoride toothpaste, provided that brushing, possibly supplemented with flossing, is carried out as demonstrated by dentists or dental hygienists. Adding professional cleaning, i.e. plaque removal with rotary brushes and flossing and performed by dentists/ dental hygienists or clinic assistants, e.g. once a month, can ensure that the lesion is stopped if daily home dental care is not optimal. If caries has occurred, it can be treated non-operatively or surgically, complemented by risk-related initiatives.
Caries can develop in relation to previously placed fillings. This is referred to as secondary caries. In contrast, the term primary caries is used for caries located on unfilled/restored areas of the tooth or its root surfaces. Whether primary or secondary, caries lesions' severity is classified as superficial, moderate or extensive. The last two diagnoses usually require operative treatment, i.e. a filling, or root canal treatment or extraction.
Caries is detected and diagnosed using a number of methods, the most common being a clinical visual/tactile examination of the teeth, complemented by radiographs. However, this method is highly subjective, and thus with large variation among dentists and dental hygienists, resulting in different treatment strategie. In addition, radiographs lack sensitivity in terms of detection of the initial caries lesions.
Researchers have therefore developed various devices and methods for a more objective modulation of mineral loss, including monitoring of individual caries lesions. Perhaps best known is the QLF (Quantitative Light Fluorescence) system, which uses fluorescence measurements of the tooth's response to demineralization. The latest technology using fluorescence for caries detection and classification is the intraoral 3D scanner with the integrated automated caries registration system, which has been developed and now for a few years has been tested in both in vitro and in vivo studies at the Department of Odontology of the University of Copenhagen (OI).
The technique is based on the fact that healthy and demineralized tooth tissue absorbs the blue-violet light (wavelength ~415 nm) and emits back fluorescent light with different light intensities, from bright green to brownish to red. In terms of detection and classification of caries lesions on occlusal surfaces, the scanner has overall a better reproducibility and a comparable accuracy expressed through sensitivity and specificity compared to a combination of the clinical and radiological examination.
Another method that has been widely investigated for the detection of initial proximal (between teeth) and occlusal caries lesions, without the use of ionizing radiation, is transillumination with near-infrared light (wavelength ~780 nm). In the transillumination method, the light is transmitted through the dental tissue. The caries lesions appear dark, like shadows, due to the scattering and absorption of the light in the porous demineralized tissue. In contrast, the healthy, transparent enamel tissue appears brighter as light penetrates this tissue with very low light scatter and almost no light absorption. This method is used by the intraoral camera "DIAGNOcam" (KaVo, Biberach, Germany) and has also been investigated by researchers from the Department of Odontology at the University of Copenhagen and 3Shape (3Shape TRIOS A/S, Copenhagen, Denmark) for implementation in the 3D intraoral scanner system. This has shown improved sensitivity in detecting initial approximal caries lesions that can be treated with preventive, non-operative methods.
One of the areas that remain to be investigated regarding the usefulness of the 3D scanner and transillumination camera as a caries diagnostic method is the monitoring of caries lesions between two or more examinations in the clinic, including how the systems respond to lesions that have received intensive treatment to stop their progression.
Method:
18-30-year-old young adults in Denmark with high caries activity. Potential participants are found by advertising for caries-active patients in the daily press, on the OI website or an announcement board at the OI.
When contacting a potential participant, information is provided about the study, in addition to what is stated in the advertisement, on the website or on announcement boards. After that the a clinical screening is conducted.
Participants (n ~33) are offered common caries prevention initiatives: improved self-care, toothbrush instruction using 1450 ppm fluoride toothpaste, dietary advice and topical fluoride treatment. In addition, selected superficial caries lesions on individual participants will be professionally cleaned once a month.
Study participants will receive dental check-ups at shorter intervals (approximately every 1.5 months) compared to standard treatment.
Participants with lesions requiring restorative treatment (media/profound lesions) or with teeth that must be extracted due to caries will be treated at the OI according to the usual rules.
A traditional clinical and radiological examination also includes the diagnosis of other pathological conditions of the oral cavity, which, if identified, will be treated at the OI, according to the usual rules, or the participant will be referred to a private dentist. Other diseases of the teeth and supporting tissues likely to be diagnosed in 18- to 30-year-olds are gingivitis, erosions and wisdom teeth which only partially emerge into the oral cavity (dentis retentus).
The examination shall be carried out at the Department of Odontology, University of Copenhagen (OI) First visit (Baseline) i) Relevant medical history. ii) Records: tooth and filling status (chart), as well as clinical plaque and gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6.
iii) X-rays: 2 BW (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental) with special holders for reproducible images.
iv) Dental cleaning and professional plaque removal, including flossing. v) 3D scanning vi) Transillumination method vii) ICDAS (International Caries Detection and Assessment System) registration viii) Treatment plan. ix) Treatment. Second visit (1.5 months) 3D intraoral scanning and ICDAS registration. Third visit (3 months) As at baseline, but no radiographs (BW). Fourth visit (~6 months) 3D intraoral scan and ICDAS registration. Fifth visit (8 months) As at 1st visit
In addition, participants will need to come a number of times to have their caries lesions that require restorative treatment treated.
At each visit, also when lesions are treated with fillings, polishing of selected lesions will be performed.
Monitoring plan The monitoring plan will be carried out in accordance with the standard procedures for clinical research at the Department of Odontology, University of Copenhagen.
Dental student Maria K. Riis will be responsible for daily data handling, secure data archiving, and recruitment of study participants.
Staff will be responsible for the overall monitoring of the study. This person (monitor) will soon be appointed by the Department of Odontology and will be responsible for a monthly check of the progress of the study, including the following parameters:
- Verification of the presence of the consent form.
- Verification that participants meet inclusion and exclusion criteria.
- Verification of data collected versus source data.
- Compliance with the protocol and documentation of any deviations
The reason for selecting participants aged 18 to 30 years is that they are more likely to have primary caries lesions (which is the focus area) than secondary caries lesions. In addition, other dental and oral diseases requiring treatment, such as extensive tooth wear, are less likely to be found during the traditional clinical and radiological examination conducted for the study in 18- to 30-year-olds compared to older individuals.
In addition, patients with chronic medical diseases or impaired salivary secretion are excluded as they are expected to have more extensive dental problems, which are not the focus of this study.
Publication of results The study protocol will be registered at www.ClinicalTrials.gov. The study results will be published in international scientific journals under the terms of the research agreement (09.01 Research collaboration agreement CPH (Copenhagen) University), to which this document is Appendix 2. This applies to negative, positive or inconclusive results. If contrary to expectations, publication in national/international journals is unsuccessful, the investigators will ensure, under the terms of the research agreement (09.01 Research collaboration agreement CPH University), that the data are published on the department's website. The research agreement (09.01 Research collaboration agreement CPH University) states that 3Shape can request that manuscript submission be postponed by up to three (3) months from the date of receipt, provided 3Shape proves that the postponement is important for 3Shape's prospects of acquiring intellectual property rights protection of the knowledge that the University has. The disclosure of knowledge shall always be made in compliance with the obligation of professional secrecy. The research agreement (09.01 Research collaboration agreement CPH University) states that 3Shape will use the anonymized clinical data for product development, regulatory and commercial activities related to 3Shape's products.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults | Experimental | Device: Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark), Device: Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1), Device: X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental), Procedure: Oral cleaningParticipants aged between 18 and 30 years old without chronic diseases but with two caries lesions or more |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medically healthy young adult patients (18-30 years old) where individuals must have ≥ 20 teeth.
- Two or more active caries lesions
Key exclusion criteria (2 listed)
- Patients with impaired salivary secretion
- Patients with chronic medical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark)Intraoral scanner which is able to generate a 3D-model of the teeth and is being used for caries detection. | Device | Young adults |
| Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1)Intraoral camera used for caries detection in the occlusal and proximal surfaces. | Device | Young adults |
| X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental)X-ray device used for caries detection. Two radiographs (bitewings) are taken, one in each side. | Device | Young adults |
| Oral cleaningRemoval of tartar and plaque. Tartar removal done at baseline and the fifth visit, but only on selected teeth at the second, third and fourth visit. Regular cleaning with a toothbrush done at all visits. | Procedure or surgery | Young adults |
Primary outcome
1st Scanner caries score
Time frame: Baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
2nd Scanner caries score
Time frame: 1.5 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
3rd Scanner caries score
Time frame: 3 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
4th Scanner caries score
Time frame: 6 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
5th Scanner caries score
Time frame: 8 months after baseline
Caries score registered using the intraoral scanner and the accompanying software (Trios, 3Shape TRIOS A/S, Denmark) which will provide an automated caries score. Scale used: 0 (sound surfaces), 1. (initial caries lesions in enamel or into the outer third of dentin), 2. (moderate - extensive caries lesions located into the middle - inner third of dentin).
1st NIR (Near-Infrared) caries score
Time frame: Baseline
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions. (Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
2nd NIR (Near-Infrared) caries score
Time frame: 8 months after baseline
Near-Infrared transillumination images of the premolar and molar teeth will be taken in order to examine the proximal and occlusal surfaces for possible caries lesions. (Score as 0-4: 0 (No caries. No dark gray area visible on approximal surface), 1 (Caries limited to enamel without any contact to the DEJ), 2 (Enamel caries with single-point contact to the DEJ), 3 (Enamel caries with extensive contact to the DEJ), 4 (Caries visible in enamel and dentin).
1st X-ray caries score
Time frame: Baseline
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
2nd X-ray caries score
Time frame: 8 months after baseline
ICDAS grades caries radiologically as no radiolucency visible=0; radiolucency in outer 1/2 of enamel=1; radiolucency in inner 1/2 of enamel ±enamel dentin border=2; radiolucency in outer 1/3 of dentin=3; radiolucency in middle 1/3 of dentin=4; and radiolucency in inner 1/3 of dentin=5.
1st Clinical ICDAS score
Time frame: Baseline
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
2nd Clinical ICDAS score
Time frame: 1.5 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
3rd Clinical ICDAS score
Time frame: 3 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
4th Clinical ICDAS score
Time frame: 6 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
5th Clinical ICDAS score
Time frame: 8 months after baseline
ICDAS registration graded as 0 = sound, brownish lesion < 1 mm = 1b, brownish lesion ≥ 1mm = 2b, whitish lesion after drying = 1w, whitish lesion without drying = 2w, fracture limited to enamel = 3, shadowing = 4, fracture exposing dentin but fracture less than ½ of extent of surface = 5, 6 as 5 but fracture ≥ ½ of extent of surface.
1st Caries activity assessment score
Time frame: Baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
2nd Caries activity assessment score
Time frame: 1.5 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
3rd Caries activity assessment score
Time frame: 3 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
4th Caries activity assessment score
Time frame: 6 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
5th Caries activity assessment score
Time frame: 8 months after baseline
The activity of the clinically identified caries lesions (active/arrested) will be based on: Localisation of the lesion (No plaque stagnation area = 0, Plaque stagnation area = 1); Colour of the lesion (Brownish = 0; Whitish = 1); Feeling with probe (Lesion Smooth = 0; Lesion Rough = 1); No breakdown/breakdown on enamel surface: (No breakdown, or breakdown with smooth border area = 0; Breakdown with rough border area = 1); In case of gingival or proximal lesions (Healthy gingiva = 0; Bleeding on probing = 1). Arrested lesions total score ≤ 2 points; Active lesions total score > 2 points.
1st Clinical plaque score
Time frame: Baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
2nd Clinical plaque score
Time frame: 1.5 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
3rd Clinical plaque score
Time frame: 3 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
4th Clinical plaque score
Time frame: 6 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
5th Clinical plaque score
Time frame: 8 months after baseline
Clinical plaque index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical plaque score: 0 (No plaque visible), 1 (A film of plaque visible when using the probe), 2 (Moderate plaque accumulation that can be seen with the naked eye), 3 (An extensive plaque accumulation).
1st Clinical gingiva score
Time frame: Baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
2nd Clinical gingiva score
Time frame: 1.5 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
3rd Clinical gingiva score
Time frame: 3 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
4th Clinical gingiva score
Time frame: 6 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
5th Clinical gingiva score
Time frame: 8 months after baseline
Clinical gingival index ad modem Løe \& Silness (1963) on selected teeth: 6+, 3+, 1+, +2, +4, +7, 7-,5-, 2-, -1, -3, -6. Clinical gingiva score: 0 (Sound gingiva), 1 (A slight redness of the gingiva, no bleeding when probed), 2 (Bleeding when probed), 3 (Spontaneous bleeding).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Background: PubMed 33053552Michou S, Benetti AR, Vannahme C, Hermannsson PG, Bakhshandeh A, Ekstrand KR. Development of a Fluorescence-Based Caries Scoring System for an Intraoral Scanner: An in vitro Study. Caries Res. 2020;54(4):324-335. doi: 10.1159/000509925. Epub 2020 Oct 14.
- Background: PubMed 25740856Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
- Background: PubMed 28540937Pitts NB, Zero DT, Marsh PD, Ekstrand K, Weintraub JA, Ramos-Gomez F, Tagami J, Twetman S, Tsakos G, Ismail A. Dental caries. Nat Rev Dis Primers. 2017 May 25;3:17030. doi: 10.1038/nrdp.2017.30.
- Background: PubMed 7039213Bellini HT, Arneberg P, von der Fehr FR. Oral hygiene and caries. A review. Acta Odontol Scand. 1981;39(5):257-65. doi: 10.3109/00016358109162287.
- Background: PubMed 15286128Lussi A, Hibst R, Paulus R. DIAGNOdent: an optical method for caries detection. J Dent Res. 2004;83 Spec No C:C80-3. doi: 10.1177/154405910408301s16.
- Background: PubMed 7867045de Josselin de Jong E, Sundstrom F, Westerling H, Tranaeus S, ten Bosch JJ, Angmar-Mansson B. A new method for in vivo quantification of changes in initial enamel caries with laser fluorescence. Caries Res. 1995;29(1):2-7. doi: 10.1159/000262032.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Intraoral scanner featuring transillumination for proximal caries detection. An in vitro validation study on permanent posterior teethLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim R. Ekstrand, ph.d study chair
Institute of Odontology, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral Scanner (TRIOS 4, 3Shape TRIOS A/S, Copenhagen, Denmark), Intraoral camera (DIAGNOcam, KaVo, Biberach, Germany, software version 3.0.1/2.9.1) and X-ray device (X-ray device SOREDEX, MINRAY®; Image plates VistaScan; Image plate scanner VistaScan Mini View, Dürr Dental) in people with Dental Caries, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st Scanner caries score (time frame: Baseline). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409625, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.