Dental Caries on Smooth Surface Limited to EnamelNCT05202665
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
A study testing ICON DMG Resin Infiltration (micro-invasive approach) and ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach) in people with Dental Caries on Smooth Surface Limited to Enamel and Tooth Demineralization, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Protection of dental hard tissues is one of the most important points of cariology. For this purpose, oral hygiene training (effective brushing and motivation), non-invasive approaches such as flouride varnish applications and micro-invasive approaches such as resin infiltration technique are applied in clinical… Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries on Smooth Surface Limited to Enamel, Tooth Demineralization, Dental Caries
- What is being tested?
- ICON DMG Resin Infiltration (micro-invasive approach) and ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2017to 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 43 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals with moderate/high risk of caries
- the presence of one or more noncavitated interproximal caries lesions with radiolucencies involving the outher half of enamel up to the outer third of dentin in bite-wing radiographies (lesion depth: E1, E2, D1)
- vital posterior teeth without cavitation in which the clinically active non-carious lesion had
- Only one tooth per patient was included in the study
Who cannot join
- incapable of contracting
- pregnancy
- presence of secondary caries or restoration in the involved tooth
- lack of contact teeth
- incapable of contracting
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Dentistry
Izmir, Bornova, 35100
About this study
Official title: The Evaluation of Resin Infiltration or Fluoride Varnish Effect on Non-cavited Proximal Caries Lesion Progress at Individuals Modarate/High Caries Risk
Protection of dental hard tissues is one of the most important points of cariology. For this purpose, oral hygiene training (effective brushing and motivation), non-invasive approaches such as flouride varnish applications and micro-invasive approaches such as resin infiltration technique are applied in clinical practice. In this study, the effect of resin infiltration or fluoride varnish application on lesion depth in individuals with moderate/high caries risk was investigated.
The study was a randomized controlled, prospective and parallel designed clinical trial. 60 patients were included in the study and patients were randomly allocate to the groups. Caries risk of individuals was determined according to Cariogram, which is a computer program․ According to visual clinical examination, stage the caries continuum were (ICDAS 1,2) scored and the caries diagnostic criteria scored acording to (Nyvad 1, 2, 4, 5) The teeth wich has one caries lesion in border of enamel or prolonged to first 1/3 part of dentin in bite-wing radiograph (lesion level: E1, E2, D1) included in this study. Patient's gingival condition evaluating at initial and control sessions with gingival index (0=healthy, 1=mild inflammation, 2=moderate inflammation and bleeding on pressure). Oral hygiene training was given to all subjects included in the study and the use of fluoride toothpaste (1450 ppm, NaF) was recommended. This study was performed in a single center by experienced physicians. Resin infiltration (Icon DMG, USA) was applied to one of the groups(n=30), while fluoride varnish (ClinproTM White Varnish 22600 ppm, 3M ESPE, USA) was applied to the other group(n=30). The patients follow-up time was anticipated for 60 months in 6-month periods. The inicial visual clinical examination(T0) and follow-up sessions (T 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) were conducted by two experienced researchers blind to the group information. At the aim of the study, evaluation difference in non-cavited proximal lesion progression between the resin infiltration (micro-invasive) and fluoride varnish (non-invasive) treatment options at the individuals with moderate or high risk of caries.
- Conditions
- Dental Caries on Smooth Surface Limited to Enamel, Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests, Cariogram
- Being tested
- ICON DMG Resin Infiltration (micro-invasive approach), ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)
- Keywords
- Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests
- Medical subject headings
- Tooth Demineralization, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICON DMG Resin Infiltration (micro-invasive approach)Procedure or surgery
A plastic wedge located below the contact point to apart from the surface from adjacent tooth. A 15% HCl etching gel (Icon, DMG, Hamburg, Germany) was applied by syringe below the contact point for 120 s. After, the gel was washed off with air-water-spray for 30 s. The lesion was desiccated by air-blowing for 10 s, application of ethanol for 30 s and air-blowing again for 30 s. A resin infiltrant (Icon, DMG, Hamburg, Germany) was applied with another plastic holder during 3 min. Following the penetration, excess of material was removed by air blowing and flossing. The resin was light-cured for 40 s total from the buccal, occlusal, and lingual/palatal aspects. It was needed to reapplicate the resin infiltration for once because of infiltrating remaining porosities during 1 minute. Excess material removing process was again repeated and light cured for 40 s.
ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)Procedure or surgery
Tooth surfaces were cleaned thoroughly and isolated with cotton rolls. According to the manufacturer's instructions, the unit dose packages were opened, and the contents were dispensed onto the application guide and mixed to avoid the separation of sodium fluoride components. A thin coat of varnish (ClinproTM White Varnish, 3M ESPE, USA) with 22600 ppm fluoride was applied to the tooth interface with a brush tip applicator and waited for 5 minutes. Aproximal areas were coated with dental floss. The patient was instructed not to rinse or apply suction immediately after application. Patients were advised to avoid eating hard and sticky foods or drinking hot beverages for the next 2 hours, to consume a soft diet immediately after 30 minutes and to avoid brushing and flossing for the rest of the day.
| Study group | Role | What they receive |
|---|---|---|
| Flouride Varnish applications (non-invasive approaches) | Experimental | ClinproTM White Varnish 22600 ppm, 3M ESPE was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion. Receives: Procedure: ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach) |
| Resin Infiltration (micro-invasive approaches) | Experimental | ICON DMG was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion. Receives: Procedure: ICON DMG Resin Infiltration (micro-invasive approach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale
The non-cavitated proximal carious lesion progression as measured by radiographic lesion depth scale, radiographic score change from baseline with radiographic lesion depth scale over 60 months in 6-month periods.
Description of the radiographic lesion depth scale scores used in this study:
E1 = radiolucency in outer half of enamel E2 = radiolucency in inner half of enamel D1= radiolucency in outer third of dentine
Measured: The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start26 Sep 2017
- Primary completion30 Mar 2018
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries on Smooth Surface Limited to EnamelStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TIJEN PAMIR, Ege University
- Investigators
- Elif Ercan Devrimci, PhD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202665
- Sponsor's protocol ID
- 70198063-050.06.04/17-8/7
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Resin Infiltration or Fluoride Varnish Effect on Non-cavited Proximal Caries Lesion Progress at Individuals Modarate/High Caries Risk
- ClinicalTrials.gov ID
- NCT05202665
- Acronym / sponsor ID
- 70198063-050.06.04/17-8/7
- Conditions
- Dental Caries on Smooth Surface Limited to Enamel, Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests, Cariogram
- Keywords
- Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 21 Jan 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.
Protection of dental hard tissues is one of the most important points of cariology. For this purpose, oral hygiene training (effective brushing and motivation), non-invasive approaches such as flouride varnish applications and micro-invasive approaches such as resin infiltration technique are applied in clinical practice. In this study, the effect of resin infiltration or fluoride varnish application on lesion depth in individuals with moderate/high caries risk was investigated.
The study was a randomized controlled, prospective and parallel designed clinical trial. 60 patients were included in the study and patients were randomly allocate to the groups. Caries risk of individuals was determined according to Cariogram, which is a computer program․ According to visual clinical examination, stage the caries continuum were (ICDAS 1,2) scored and the caries diagnostic criteria scored acording to (Nyvad 1, 2, 4, 5) The teeth wich has one caries lesion in border of enamel or prolonged to first 1/3 part of dentin in bite-wing radiograph (lesion level: E1, E2, D1) included in this study. Patient's gingival condition evaluating at initial and control sessions with gingival index (0=healthy, 1=mild inflammation, 2=moderate inflammation and bleeding on pressure). Oral hygiene training was given to all subjects included in the study and the use of fluoride toothpaste (1450 ppm, NaF) was recommended. This study was performed in a single center by experienced physicians. Resin infiltration (Icon DMG, USA) was applied to one of the groups(n=30), while fluoride varnish (ClinproTM White Varnish 22600 ppm, 3M ESPE, USA) was applied to the other group(n=30). The patients follow-up time was anticipated for 60 months in 6-month periods. The inicial visual clinical examination(T0) and follow-up sessions (T 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) were conducted by two experienced researchers blind to the group information. At the aim of the study, evaluation difference in non-cavited proximal lesion progression between the resin infiltration (micro-invasive) and fluoride varnish (non-invasive) treatment options at the individuals with moderate or high risk of caries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flouride Varnish applications (non-invasive approaches) | Experimental | Procedure: ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)ClinproTM White Varnish 22600 ppm, 3M ESPE was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion. |
| Resin Infiltration (micro-invasive approaches) | Experimental | Procedure: ICON DMG Resin Infiltration (micro-invasive approach)ICON DMG was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- individuals with moderate/high risk of caries
- the presence of one or more noncavitated interproximal caries lesions with radiolucencies involving the outher half of enamel up to the outer third of dentin in bite-wing radiographies (lesion depth: E1, E2, D1)
- vital posterior teeth without cavitation in which the clinically active non-carious lesion had
- Only one tooth per patient was included in the study
Key exclusion criteria (5 listed)
- incapable of contracting
- pregnancy
- presence of secondary caries or restoration in the involved tooth
- lack of contact teeth
- incapable of contracting
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 |
|---|---|---|
| ICON DMG Resin Infiltration (micro-invasive approach)A plastic wedge located below the contact point to apart from the surface from adjacent tooth. A 15% HCl etching gel (Icon, DMG, Hamburg, Germany) was applied by syringe below the contact point for 120 s. After, the gel was washed off with air-water-spray for 30 s. The lesion was desiccated by air-blowing for 10 s, application of ethanol for 30 s and air-blowing again for 30 s. A resin infiltrant (Icon, DMG, Hamburg, Germany) was applied with another plastic holder during 3 min. Following the penetration, excess of material was removed by air blowing and flossing. The resin was light-cured for 40 s total from the buccal, occlusal, and lingual/palatal aspects. It was needed to reapplicate the resin infiltration for once because of infiltrating remaining porosities during 1 minute. Excess material removing process was again repeated and light cured for 40 s. | Procedure or surgery | Resin Infiltration (micro-invasive approaches) |
| ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)Tooth surfaces were cleaned thoroughly and isolated with cotton rolls. According to the manufacturer's instructions, the unit dose packages were opened, and the contents were dispensed onto the application guide and mixed to avoid the separation of sodium fluoride components. A thin coat of varnish (ClinproTM White Varnish, 3M ESPE, USA) with 22600 ppm fluoride was applied to the tooth interface with a brush tip applicator and waited for 5 minutes. Aproximal areas were coated with dental floss. The patient was instructed not to rinse or apply suction immediately after application. Patients were advised to avoid eating hard and sticky foods or drinking hot beverages for the next 2 hours, to consume a soft diet immediately after 30 minutes and to avoid brushing and flossing for the rest of the day. | Procedure or surgery | Flouride Varnish applications (non-invasive approaches) |
Primary outcome
The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale
Time frame: The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.
The non-cavitated proximal carious lesion progression as measured by radiographic lesion depth scale, radiographic score change from baseline with radiographic lesion depth scale over 60 months in 6-month periods. Description of the radiographic lesion depth scale scores used in this study: E1 = radiolucency in outer half of enamel E2 = radiolucency in inner half of enamel D1= radiolucency in outer third of dentine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- MI varnish and MI paste plus in a caries prevention and remineralization study: A randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Elif Ercan Devrimci, PhD study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICON DMG Resin Infiltration (micro-invasive approach) and ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach) in people with Dental Caries on Smooth Surface Limited to Enamel and Tooth Demineralization, run by Ege University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 21 Jan 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale (time frame: The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.