White Spot LesionPhase 4WSLNCT06051981
White Spot Lesions Treatment in Orthodontic
A Phase 4 study testing 5% sodium fluoride, Intensive 5% sodium fluoride and Casein Phosphopeptide-Amorphous Calcium Phosphate in people with White Spot Lesion, run by Riyadh Elm University.
Trial summary
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- 5% sodium fluoride, Intensive 5% sodium fluoride and Casein Phosphopeptide-Amorphous Calcium Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Mar 2024
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
- Agreeing to participate in the study by singing the study informed consent.
- For younger patients parents agree to provide consent for child participation in the study.
Who cannot join
- Developmental defects of dental hard tissue
- Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
- Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial
The study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic.
A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Read the detailed description
Trial design The study will be conducted as a prospective clinical controlled trial with an experimental design, consisting of four parallel groups. Individuals who experienced the development of demineralized white spot lesions after undergoing fixed appliance therapy will be invited to participate in the study and will be assigned to one of the following groups: control group, Fluoride Varnish (FV) group, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) group, or Resin Infiltration (RI) group.
Participants Patients will be recruited by navigating the electronic record system of Riyadh Elm University from 2023 files backward up to 2022, identifying patients who completed orthodontic treatment reaching up to the required sample size. Those patients will be contacted by phone call from the dental clinic of Riyadh Elm University official number, inviting them to participate in the current study. Patients will be given an appointment to visit the dental clinic at specific time. Before enrollment, every patient or parent/legal guardian of a patient younger than 18 years of age will receive an informational letter and verbal communication about the objectives and protocol of the study. All enrolled patients and/or their parents or legal guardians will be asked to provide a written informed consent following their initial approval. All patients who got treatment in Riyadh Elm University signed consents to share their information for research purposes will be enrolled in the study.
Calibration exercise A total of 22 patients with WSLs attending dental clinics of REU will be selected and two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth to code the WSL against the ICDAS system. Whenever in doubt regarding the coding of the WSLs, the third expert examiner decision will be considered final. The level of agreement with regard to the ICDAS codes between the two examiners will be assessed using reliability analysis and the agreement level of above 80% will be considered.
Two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth. Each WSL will be identified by visual inspection of mesiobuccal, buccal, or distobuccal tooth surfaces and recorded. An ICDAS code will be assigned to each WSL. A digital photograph will be taken by keeping 45 cm distance between subject and camera. The digital image of WS can be captured with a digital camera (Canon EOS 2000D (NIS) DSLR Camera 18 - 55 mm NIS Lens) held almost perpendicular to the buccal surface. Light is supplied by a flash mounted around lens. The camera system setup was adjusted as follows; the quality of image is Fine, ISO is 200, and white balance is speed light mode. Moreover, dental status of the participants also recorded.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial surface or the distal surface. WSLs that will be coded 3 (denoted by localized enamel breakdown caused by caries without the presence of dentin and underlying shadow), or higher (denoted by the presence of underlying dark shadow caused by dentin, whether enamel-depleting or not, to a large distinct cavity containing visible dentin), in accordance with ICDAS reference, are excluded from further examination and will be appropriately treated.
Following the determination of the 0 LF value for each tooth on a healthy surface, the maximum LF value for each WSL coded tooth (either 1 or 2) will be determined using a DIAGNODent flat tip (KaVo dental, GmbH, Biberach, Germany). Measurements will be done according to the manufacturer's instructions. Each tooth will be dried for 5 seconds, and the tip will be pointed in the opposite direction from the examination area. The measurement will be done using the DIAGNOdent Scale; values 0±13: no caries, values 14±20: enamel caries and values >20: dentinal caries. (Lussi et al., 2001).
Eligibility criteria for participants Inclusion criteria
- Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
- Agreeing to participate in the study by singing the study informed consent.
- For younger patients parents agree to provide consent for child participation in the study.
Exclusion criteria
- Developmental defects of dental hard tissue
- Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
- Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration. Study settings Data will be collected from orthodontic clinics of Namouthajya and Muneseya hospitals at Riyadh Elm University, Riyadh, Saudi Arabia.
Intervention In group I (Control group): FV EnamelastTM (a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions: compressed air and cotton rolls will be used to dry the teeth. A mini brush will be used to apply varnish to all teeth surfaces. The varnish will be left to dry for one minute. Patients should avoid eating, drinking, or brushing for a period of 3-4 hours following the application of varnish. In the test groups (group II): Intensive FV will be applied three times a week for a week (every two days). For group III: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan) for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water (Thierens et al., 2019). For group IV: ICON® (DMG, Hamburg, Germany) resin infiltration will be applied as specified by the manufacturer: the 15% hydrochloric acid (HCL) solution will be sprayed for 2 minutes, followed by rinsing with water for 30 seconds and drying. Application of ICON-Dry (Ethanol) for 30 seconds, followed by air drying. Subsequently, ICON-Infiltration will be applied to the tooth surface and left for 3 minutes. The excess resin will be removed using a cotton roll, followed by a light curing process lasting for 40 seconds. Finally, the enamel surface that has been roughened will be polished with composite resin polish discs and polish cups.
- Conditions
- White Spot Lesion
- Being tested
- 5% sodium fluoride, Intensive 5% sodium fluoride, Casein Phosphopeptide-Amorphous Calcium Phosphate, Resin infiltration
- Keywords
- Fixed orthodontic Appliances, White Spot Lesion, Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, Resin Infiltration, Laser Fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% sodium fluorideDrug
Also called FV EnamelastTM
a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions.
Intensive 5% sodium fluorideDrug
Also called EnamelastTM
Intensive FV will be applied three times a week for a week (every two days).
Casein Phosphopeptide-Amorphous Calcium PhosphateDrug
Also called (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan)
for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water
Resin infiltrationDrug
Also called ICON® (DMG, Hamburg, Germany)
resin infiltration will be applied as specified by the manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish (control) | Experimental | The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. In group I, FV EnamelastTM will be applied to all teeth using compressed air and cotton rolls, leaving them to dry for one minute. Patients will be advised to avoid eating, drinking, or brushing for 3-4 hours after application. Receives: Drug: 5% sodium fluoride |
| Intensive Fluoride Varnish | Experimental | The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Patients in group II Intensive FV will be applied three times a week for a week (every two days). Receives: Drug: Intensive 5% sodium fluoride |
| Casein Phosphopeptide-Amorphous Calcium Phosphate | Experimental | The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group III (CPP-ACP) uses Tooth Mousse® for 12 weeks, will be applied after daily brushing with traditional toothpaste, left intact for 180 seconds, and rinsed with distilled water. Receives: Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate |
| Resin Infiltration | Experimental | The study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group IV uses ICON® resin infiltration, applying a 15% hydrochloric acid solution, rinsing with water, drying, and applying ICON-Dry. Excess resin is removed, and a light curing process is performed. The roughened enamel surface is polished using composite resin polish discs and cups. Receives: Drug: Resin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mineral contents of enamel
The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20.
Measured: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once the FV has been applied, the examiners at Riyadh Elm University will do a visual inspection and take LF measurements (T2) on all the areas that were marked as WSL on the initial photos. The LF measurement will be carried out by the same inspectors who carried out the visual inspection. At the end of treatment for groups II, III, IV, a visual examination and LF measurements (T2) will be conducted by the same examiners. At the next inspection (after 3 months (T3)), LF measurements will be carried out on all areas that were marked as WSL on the original photos, whether they are still existing WSL areas or they will be changed to WSL free areas.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Fawaz M Algasn, Riyadh Elm University
- Investigators
- Samira Algasn, BDS, Principal investigator, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051981
- Sponsor's protocol ID
- FPGRP/2023/780
- Acronym
- WSL
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
PubMed 15591733Ferreira JM, Silva MF, Oliveira AF, Sampaio FC. Evaluation of different methods for monitoring incipient carious lesions in smooth surfaces under fluoride varnish therapy. Int J Paediatr Dent. 2008 Jul;18(4):300-5. doi: 10.1111/j.1365-263X.2007.00879.x.
PubMed 18554336Lussi A, Megert B, Longbottom C, Reich E, Francescut P. Clinical performance of a laser fluorescence device for detection of occlusal caries lesions. Eur J Oral Sci. 2001 Feb;109(1):14-9. doi: 10.1034/j.1600-0722.2001.109001014.x.
PubMed 11330928Makhija SK, Bader JD, Shugars DA, Litaker MS, Nagarkar S, Gordan VV, Rindal DB, Pihlstrom DJ, Mungia R, Meyerowitz C, Gilbert GH; National Dental Practice-Based Research Network (PBRN) Collaborative Group. Influence of 2 caries-detecting devices on clinical decision making and lesion depth for suspicious occlusal lesions: A randomized trial from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2018 Apr;149(4):299-307.e1. doi: 10.1016/j.adaj.2017.11.001. Epub 2018 Feb 21.
PubMed 29475554Melrose CA, Appleton J, Lovius BB. A scanning electron microscopic study of early enamel caries formed in vivo beneath orthodontic bands. Br J Orthod. 1996 Feb;23(1):43-7. doi: 10.1179/bjo.23.1.43.
PubMed 8652497Migliorati M, Isaia L, Cassaro A, Rivetti A, Silvestrini-Biavati F, Gastaldo L, Piccardo I, Dalessandri D, Silvestrini-Biavati A. Efficacy of professional hygiene and prophylaxis on preventing plaque increase in orthodontic patients with multibracket appliances: a systematic review. Eur J Orthod. 2015 Jun;37(3):297-307. doi: 10.1093/ejo/cju044. Epub 2014 Sep 22.
PubMed 25246605Aljehani A, Yousif MA, Angmar-Mansson B, Shi XQ. Longitudinal quantification of incipient carious lesions in postorthodontic patients using a fluorescence method. Eur J Oral Sci. 2006 Oct;114(5):430-4. doi: 10.1111/j.1600-0722.2006.00395.x.
PubMed 17026510Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.
PubMed 25126675Kau CH, Wang J, Palombini A, Abou-Kheir N, Christou T. Effect of fluoride dentifrices on white spot lesions during orthodontic treatment: A randomized trial. Angle Orthod. 2019 May;89(3):365-371. doi: 10.2319/051818-371.1. Epub 2019 Feb 5.
PubMed 30719933Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
PubMed 26418918Meyer-Lueckel H, Paris S. Progression of artificial enamel caries lesions after infiltration with experimental light curing resins. Caries Res. 2008;42(2):117-24. doi: 10.1159/000118631. Epub 2008 Feb 28.
PubMed 18305389Nascimento PL, Fernandes MT, Figueiredo FE, Faria-E-Silva AL. Fluoride-Releasing Materials to Prevent White Spot Lesions around Orthodontic Brackets: A Systematic Review. Braz Dent J. 2016 Jan-Feb;27(1):101-7. doi: 10.1590/0103-6440201600482.
PubMed 27007355Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.
PubMed 33009565
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, and Resin Infiltration in the Treatment of White Spot Lesions After Orthodontic Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06051981
- Acronym / sponsor ID
- WSL / FPGRP/2023/780
- Conditions
- White Spot Lesion
- Keywords
- Fixed orthodontic Appliances, White Spot Lesion, Fluoride Varnish, Casein Phosphopeptide-Amorphous Calcium Phosphate, Resin Infiltration, Laser Fluorescence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 25 Sep 2023 (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 study aims to investigate the effectiveness of a new treatment for demineralized white spot lesions (WSLs) after fixed appliance therapy. The trial will consist of four parallel groups: control, Fluoride Varnish (FV), Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP), and Resin Infiltration (RI) groups. Patients will be recruited from Riyadh Elm University's electronic record system and contacted by phone. They will be given an appointment to visit the dental clinic.
A total of 22 patients with WSLs will be selected for the study. Two examiners will perform dental examinations using a dental mirror and a ball-ended probe to code the WSL against the ICDAS system. The level of agreement between the two examiners will be assessed using reliability analysis, with an agreement level of above 80% considered.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial or distal surface. WSLs coded 3 or higher will be excluded from further examination and treated accordingly.
Detailed description
Trial design The study will be conducted as a prospective clinical controlled trial with an experimental design, consisting of four parallel groups. Individuals who experienced the development of demineralized white spot lesions after undergoing fixed appliance therapy will be invited to participate in the study and will be assigned to one of the following groups: control group, Fluoride Varnish (FV) group, Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) group, or Resin Infiltration (RI) group.
Participants Patients will be recruited by navigating the electronic record system of Riyadh Elm University from 2023 files backward up to 2022, identifying patients who completed orthodontic treatment reaching up to the required sample size. Those patients will be contacted by phone call from the dental clinic of Riyadh Elm University official number, inviting them to participate in the current study. Patients will be given an appointment to visit the dental clinic at specific time. Before enrollment, every patient or parent/legal guardian of a patient younger than 18 years of age will receive an informational letter and verbal communication about the objectives and protocol of the study. All enrolled patients and/or their parents or legal guardians will be asked to provide a written informed consent following their initial approval. All patients who got treatment in Riyadh Elm University signed consents to share their information for research purposes will be enrolled in the study.
Calibration exercise A total of 22 patients with WSLs attending dental clinics of REU will be selected and two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth to code the WSL against the ICDAS system. Whenever in doubt regarding the coding of the WSLs, the third expert examiner decision will be considered final. The level of agreement with regard to the ICDAS codes between the two examiners will be assessed using reliability analysis and the agreement level of above 80% will be considered.
Two examiners will perform dental examinations using a dental mirror and a ball-ended probe on wet and dry debris-free teeth. Each WSL will be identified by visual inspection of mesiobuccal, buccal, or distobuccal tooth surfaces and recorded. An ICDAS code will be assigned to each WSL. A digital photograph will be taken by keeping 45 cm distance between subject and camera. The digital image of WS can be captured with a digital camera (Canon EOS 2000D (NIS) DSLR Camera 18 - 55 mm NIS Lens) held almost perpendicular to the buccal surface. Light is supplied by a flash mounted around lens. The camera system setup was adjusted as follows; the quality of image is Fine, ISO is 200, and white balance is speed light mode. Moreover, dental status of the participants also recorded.
Buccal WSLs will be defined as those that extend from the center of the buccal to either the mesial surface or the distal surface. WSLs that will be coded 3 (denoted by localized enamel breakdown caused by caries without the presence of dentin and underlying shadow), or higher (denoted by the presence of underlying dark shadow caused by dentin, whether enamel-depleting or not, to a large distinct cavity containing visible dentin), in accordance with ICDAS reference, are excluded from further examination and will be appropriately treated.
Following the determination of the 0 LF value for each tooth on a healthy surface, the maximum LF value for each WSL coded tooth (either 1 or 2) will be determined using a DIAGNODent flat tip (KaVo dental, GmbH, Biberach, Germany). Measurements will be done according to the manufacturer's instructions. Each tooth will be dried for 5 seconds, and the tip will be pointed in the opposite direction from the examination area. The measurement will be done using the DIAGNOdent Scale; values 0±13: no caries, values 14±20: enamel caries and values >20: dentinal caries. (Lussi et al., 2001).
Eligibility criteria for participants Inclusion criteria
- Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
- Agreeing to participate in the study by singing the study informed consent.
- For younger patients parents agree to provide consent for child participation in the study.
Exclusion criteria
- Developmental defects of dental hard tissue
- Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
- Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration. Study settings Data will be collected from orthodontic clinics of Namouthajya and Muneseya hospitals at Riyadh Elm University, Riyadh, Saudi Arabia.
Intervention In group I (Control group): FV EnamelastTM (a flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions: compressed air and cotton rolls will be used to dry the teeth. A mini brush will be used to apply varnish to all teeth surfaces. The varnish will be left to dry for one minute. Patients should avoid eating, drinking, or brushing for a period of 3-4 hours following the application of varnish. In the test groups (group II): Intensive FV will be applied three times a week for a week (every two days). For group III: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan) for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water (Thierens et al., 2019). For group IV: ICON® (DMG, Hamburg, Germany) resin infiltration will be applied as specified by the manufacturer: the 15% hydrochloric acid (HCL) solution will be sprayed for 2 minutes, followed by rinsing with water for 30 seconds and drying. Application of ICON-Dry (Ethanol) for 30 seconds, followed by air drying. Subsequently, ICON-Infiltration will be applied to the tooth surface and left for 3 minutes. The excess resin will be removed using a cotton roll, followed by a light curing process lasting for 40 seconds. Finally, the enamel surface that has been roughened will be polished with composite resin polish discs and polish cups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Once the FV has been applied, the examiners at Riyadh Elm University will do a visual inspection and take LF measurements (T2) on all the areas that were marked as WSL on the initial photos. The LF measurement will be carried out by the same inspectors who carried out the visual inspection. At the end of treatment for groups II, III, IV, a visual examination and LF measurements (T2) will be conducted by the same examiners. At the next inspection (after 3 months (T3)), LF measurements will be carried out on all areas that were marked as WSL on the original photos, whether they are still existing WSL areas or they will be changed to WSL free areas.
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish (control) | Experimental | Drug: 5% sodium fluorideThe study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. In group I, FV EnamelastTM will be applied to all teeth using compressed air and cotton rolls, leaving them to dry for one minute. Patients will be advised to avoid eating, drinking, or brushing for 3-4 hours after application. |
| Intensive Fluoride Varnish | Experimental | Drug: Intensive 5% sodium fluorideThe study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Patients in group II Intensive FV will be applied three times a week for a week (every two days). |
| Casein Phosphopeptide-Amorphous Calcium Phosphate | Experimental | Drug: Casein Phosphopeptide-Amorphous Calcium PhosphateThe study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group III (CPP-ACP) uses Tooth Mousse® for 12 weeks, will be applied after daily brushing with traditional toothpaste, left intact for 180 seconds, and rinsed with distilled water. |
| Resin Infiltration | Experimental | Drug: Resin infiltrationThe study involves 22 patients with WSLs at Riyadh Elm University's dental clinics, who will undergo dental examinations and receive ICDAS codes. Group IV uses ICON® resin infiltration, applying a 15% hydrochloric acid solution, rinsing with water, drying, and applying ICON-Dry. Excess resin is removed, and a light curing process is performed. The roughened enamel surface is polished using composite resin polish discs and cups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Post orthodontic patients with one WSLs on buccal surface of tooth with ICDAS Code 1 or 2.
- Agreeing to participate in the study by singing the study informed consent.
- For younger patients parents agree to provide consent for child participation in the study.
Key exclusion criteria (3 listed)
- Developmental defects of dental hard tissue
- Patients who have systemic disease or under medications that usually cause an increased risk of oral caries.
- Patients who are allergic to Fluoride varnish, CPP-ACP and resin infiltration.
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 |
|---|---|---|
| 5% sodium fluorideAlso: FV EnamelastTMa flavored xylitol-sweetened, 5% sodium fluoride in a resin carrier delivered in a 1.2 ml syringe or in a 0.4 ml unit, Ultradent, USA) will be applied on all teeth according to the manufacturer's instructions. | Drug | Fluoride Varnish (control) |
| Intensive 5% sodium fluorideAlso: EnamelastTMIntensive FV will be applied three times a week for a week (every two days). | Drug | Intensive Fluoride Varnish |
| Casein Phosphopeptide-Amorphous Calcium PhosphateAlso: (CPP-ACP), Tooth Mousse® (MI Paste®) (GC Corporation, Tokyo, Japan)for 12 weeks. A thin layer from Tooth Mousse™ will be applied to the teeth after daily brushing with traditional toothpaste and left intact for 180 seconds before rinsing with distilled water | Drug | Casein Phosphopeptide-Amorphous Calcium Phosphate |
| Resin infiltrationAlso: ICON® (DMG, Hamburg, Germany)resin infiltration will be applied as specified by the manufacturer. | Drug | Resin Infiltration |
Primary outcome
Change in mineral contents of enamel
Time frame: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)
The maximum light fluorescence value for each tooth with a white spot lesion will be determined using a DIAGNODent flat tip, following manufacturer's instructions. The DIAGNOdent scale will be used to measure the mineral content of enamel, with values ranging from 0 to 20.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 15591733Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.
- Background: PubMed 18554336Ferreira JM, Silva MF, Oliveira AF, Sampaio FC. Evaluation of different methods for monitoring incipient carious lesions in smooth surfaces under fluoride varnish therapy. Int J Paediatr Dent. 2008 Jul;18(4):300-5. doi: 10.1111/j.1365-263X.2007.00879.x.
- Background: PubMed 11330928Lussi A, Megert B, Longbottom C, Reich E, Francescut P. Clinical performance of a laser fluorescence device for detection of occlusal caries lesions. Eur J Oral Sci. 2001 Feb;109(1):14-9. doi: 10.1034/j.1600-0722.2001.109001014.x.
- Background: PubMed 29475554Makhija SK, Bader JD, Shugars DA, Litaker MS, Nagarkar S, Gordan VV, Rindal DB, Pihlstrom DJ, Mungia R, Meyerowitz C, Gilbert GH; National Dental Practice-Based Research Network (PBRN) Collaborative Group. Influence of 2 caries-detecting devices on clinical decision making and lesion depth for suspicious occlusal lesions: A randomized trial from The National Dental Practice-Based Research Network. J Am Dent Assoc. 2018 Apr;149(4):299-307.e1. doi: 10.1016/j.adaj.2017.11.001. Epub 2018 Feb 21.
- Background: PubMed 8652497Melrose CA, Appleton J, Lovius BB. A scanning electron microscopic study of early enamel caries formed in vivo beneath orthodontic bands. Br J Orthod. 1996 Feb;23(1):43-7. doi: 10.1179/bjo.23.1.43.
- Background: PubMed 25246605Migliorati M, Isaia L, Cassaro A, Rivetti A, Silvestrini-Biavati F, Gastaldo L, Piccardo I, Dalessandri D, Silvestrini-Biavati A. Efficacy of professional hygiene and prophylaxis on preventing plaque increase in orthodontic patients with multibracket appliances: a systematic review. Eur J Orthod. 2015 Jun;37(3):297-307. doi: 10.1093/ejo/cju044. Epub 2014 Sep 22.
- Results publication: PubMed 17026510Aljehani A, Yousif MA, Angmar-Mansson B, Shi XQ. Longitudinal quantification of incipient carious lesions in postorthodontic patients using a fluorescence method. Eur J Oral Sci. 2006 Oct;114(5):430-4. doi: 10.1111/j.1600-0722.2006.00395.x.
- Results publication: PubMed 25126675Eckstein A, Helms HJ, Knosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow-up. Angle Orthod. 2015 May;85(3):374-80. doi: 10.2319/050914-334.1. Epub 2014 Aug 15.
- Results publication: PubMed 30719933Kau CH, Wang J, Palombini A, Abou-Kheir N, Christou T. Effect of fluoride dentifrices on white spot lesions during orthodontic treatment: A randomized trial. Angle Orthod. 2019 May;89(3):365-371. doi: 10.2319/051818-371.1. Epub 2019 Feb 5.
- Results publication: PubMed 26418918Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
- Results publication: PubMed 18305389Meyer-Lueckel H, Paris S. Progression of artificial enamel caries lesions after infiltration with experimental light curing resins. Caries Res. 2008;42(2):117-24. doi: 10.1159/000118631. Epub 2008 Feb 28.
- Results publication: PubMed 27007355Nascimento PL, Fernandes MT, Figueiredo FE, Faria-E-Silva AL. Fluoride-Releasing Materials to Prevent White Spot Lesions around Orthodontic Brackets: A Systematic Review. Braz Dent J. 2016 Jan-Feb;27(1):101-7. doi: 10.1590/0103-6440201600482.
- CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective studyLink 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.
Samira Algasn, BDS principal investigator
Riyadh Elm University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5% sodium fluoride, Intensive 5% sodium fluoride and Casein Phosphopeptide-Amorphous Calcium Phosphate in people with White Spot Lesion, run by Riyadh Elm University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira Algasn, BDS (966500929996, samira.m.algasn2021@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mineral contents of enamel (time frame: Baseline pre-treatment (T1), immediately post-treatment (T2), and three months post-treatment (T3)). 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 NCT06051981, which also lists 13 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 25 Sep 2023.