Dental CariesNCT07112963
"Comparison of the Effects of Resin Infiltrant, Fluoride Varnish, and the Combined Application of Resin Infiltrant and Fluoride Varnish on Primary Molars in the Treatment of Proximal Non-Cavitated Carious Lesions in Children."
A study testing Fluoride Varnish in people with Dental Caries and Tooth Demineralization, run by Sacide Duman at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This randomized controlled clinical trial aimed to compare the effectiveness of fluoride varnish, resin infiltrant, and their combination in treating superficial proximal carious lesions in primary molars of children aged 4 to 9 years. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries, Tooth Demineralization, Pediatric Dentistry
- What is being tested?
- Fluoride Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2023to 1 Jan 2026
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4-9 years
- Presence of non-cavitated proximal carious lesions in primary molars
- Consent obtained from parents or legal guardians
Who cannot join
- Cavitated or advanced proximal carious lesions
- Known allergy to fluoride varnish or resin infiltrant materials
- Systemic diseases affecting oral health or participation
- Prior restorative treatment on the target teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University, Faculty of Dentistry
Malatya, Malatya, 44000
About this study
Purpose:
This randomized controlled clinical trial aimed to compare the effectiveness of fluoride varnish, resin infiltrant, and their combination in treating superficial proximal carious lesions in primary molars of children aged 4 to 9 years.
Materials and Methods:
Twenty-six children with initial proximal caries (E1, E2, D1) on primary molars were randomly assigned to three groups: fluoride varnish only (F), resin infiltration only (RI), and resin infiltration combined with fluoride varnish (RI+F). Treatments were applied according to standardized protocols, and clinical and radiographic evaluations were conducted at 3, 6, 9, and 12 months.
Read the detailed description
This randomized controlled clinical trial investigates the comparative effectiveness of fluoride varnish, resin infiltrant, and their combined use in managing superficial proximal carious lesions in primary molars of children aged 4 to 9 years. A total of 26 pediatric patients presenting with initial proximal caries lesions classified as E1, E2, and D1 levels were enrolled. Participants were randomly allocated into three groups: fluoride varnish only (F), resin infiltration only (RI), and a combination of resin infiltration with fluoride varnish (RI+F).
Interventions were applied according to standardized clinical protocols. Follow-up assessments, including clinical examinations and radiographic evaluations, were conducted at 3, 6, 9, and 12 months post-treatment to monitor lesion progression or regression. The primary outcome measure was the change in caries lesion status over time, evaluated through clinical and radiographic criteria.
- Being tested
- Fluoride Varnish
- Keywords
- Fluoride varnish, Proximal caries, Pediatric dentistry, Resins, Synthetic
- Medical subject headings
- Dental Caries, Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDrug
Also called Resin Infiltration, Resin Infiltration and Fluoride Varnish Combination
Application of fluoride varnish to proximal surfaces of primary molars following standard clinical protocols to promote remineralization and arrest early carious lesions.
Application of resin infiltrant material to proximal non-cavitated carious lesions in primary molars, performed according to manufacturer instructions to arrest lesion progression.
Sequential application of resin infiltration followed by fluoride varnish on proximal surfaces of primary molars to maximize caries arrest and remineralization effects.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Varnish Group | Active comparator | Participants in this group receive only fluoride varnish applications according to standard clinical protocols. The treatment aims to remineralize early proximal carious lesions and prevent progression. Receives: Drug: Fluoride Varnish |
| Resin Infiltration Group | Experimental | Participants in this group receive resin infiltration treatment alone, applied following manufacturer guidelines and standardized procedures, aiming to arrest or reverse early enamel carious lesions. Receives: Drug: Fluoride Varnish |
| Resin Infiltration + Fluoride Varnish Group | Experimental | Participants in this group receive a combined intervention of resin infiltration followed by fluoride varnish application. The combined treatment is intended to maximize caries arrest and promote remineralization of proximal lesions. Receives: Drug: Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries Lesion Progression
The primary outcome is the clinical and radiographic assessment of proximal carious lesion progression or arrest in primary molars over a 12-month follow-up period. Lesion status will be evaluated at 3, 6, 9, and 12 months to determine treatment efficacy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start4 Oct 2023
- Primary completion1 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned into three parallel groups: fluoride varnish only, resin infiltration only, and a combination of resin infiltration and fluoride varnish. Each group received its designated intervention, and no crossover occurred between groups.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sacide Duman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sacide Duman, Inonu University
- Investigators
- Gizem Tıraşçı, Research ass., Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112963
- Sponsor's protocol ID
- 2022/80
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) from this study will be shared in a de-identified form. Data will be made available upon reasonable request to the corresponding author after publication of the primary results. Access will be granted following approval of a data use agreement and ethics compliance.
Publications
Paris S, Meyer-Lueckel H. Infiltrants inhibit progression of natural caries lesions in vitro. J Dent Res. 2010 Nov;89(11):1276-80. doi: 10.1177/0022034510376040. Epub 2010 Aug 25.
PubMed 20739697Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.
PubMed 22257664
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of the Effects of Resin Infiltrant, Fluoride Varnish, and the Combined Application of Resin Infiltrant and Fluoride Varnish on Primary Molars in the Treatment of Proximal Non-Cavitated Carious Lesions in Children."
- ClinicalTrials.gov ID
- NCT07112963
- Acronym / sponsor ID
- 2022/80
- Keywords
- Fluoride varnish, Proximal caries, Pediatric dentistry, Resins, Synthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sacide DumanUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 8 Aug 2025 (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.
Purpose:
This randomized controlled clinical trial aimed to compare the effectiveness of fluoride varnish, resin infiltrant, and their combination in treating superficial proximal carious lesions in primary molars of children aged 4 to 9 years.
Materials and Methods:
Twenty-six children with initial proximal caries (E1, E2, D1) on primary molars were randomly assigned to three groups: fluoride varnish only (F), resin infiltration only (RI), and resin infiltration combined with fluoride varnish (RI+F). Treatments were applied according to standardized protocols, and clinical and radiographic evaluations were conducted at 3, 6, 9, and 12 months.
Detailed description
This randomized controlled clinical trial investigates the comparative effectiveness of fluoride varnish, resin infiltrant, and their combined use in managing superficial proximal carious lesions in primary molars of children aged 4 to 9 years. A total of 26 pediatric patients presenting with initial proximal caries lesions classified as E1, E2, and D1 levels were enrolled. Participants were randomly allocated into three groups: fluoride varnish only (F), resin infiltration only (RI), and a combination of resin infiltration with fluoride varnish (RI+F).
Interventions were applied according to standardized clinical protocols. Follow-up assessments, including clinical examinations and radiographic evaluations, were conducted at 3, 6, 9, and 12 months post-treatment to monitor lesion progression or regression. The primary outcome measure was the change in caries lesion status over time, evaluated through clinical and radiographic criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly assigned into three parallel groups: fluoride varnish only, resin infiltration only, and a combination of resin infiltration and fluoride varnish. Each group received its designated intervention, and no crossover occurred between groups.
| Arm | Type | Receives |
|---|---|---|
| Fluoride Varnish Group | Active comparator | Drug: Fluoride VarnishParticipants in this group receive only fluoride varnish applications according to standard clinical protocols. The treatment aims to remineralize early proximal carious lesions and prevent progression. |
| Resin Infiltration Group | Experimental | Drug: Fluoride VarnishParticipants in this group receive resin infiltration treatment alone, applied following manufacturer guidelines and standardized procedures, aiming to arrest or reverse early enamel carious lesions. |
| Resin Infiltration + Fluoride Varnish Group | Experimental | Drug: Fluoride VarnishParticipants in this group receive a combined intervention of resin infiltration followed by fluoride varnish application. The combined treatment is intended to maximize caries arrest and promote remineralization of proximal lesions. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 4-9 years
- Presence of non-cavitated proximal carious lesions in primary molars
- Consent obtained from parents or legal guardians
Key exclusion criteria (4 listed)
- Cavitated or advanced proximal carious lesions
- Known allergy to fluoride varnish or resin infiltrant materials
- Systemic diseases affecting oral health or participation
- Prior restorative treatment on the target teeth
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 |
|---|---|---|
| Fluoride VarnishAlso: Resin Infiltration, Resin Infiltration and Fluoride Varnish CombinationApplication of fluoride varnish to proximal surfaces of primary molars following standard clinical protocols to promote remineralization and arrest early carious lesions. Application of resin infiltrant material to proximal non-cavitated carious lesions in primary molars, performed according to manufacturer instructions to arrest lesion progression. Sequential application of resin infiltration followed by fluoride varnish on proximal surfaces of primary molars to maximize caries arrest and remineralization effects. | Drug | Fluoride Varnish Group, Resin Infiltration + Fluoride Varnish Group, Resin Infiltration Group |
Primary outcome
Caries Lesion Progression
Time frame: 12 months
The primary outcome is the clinical and radiographic assessment of proximal carious lesion progression or arrest in primary molars over a 12-month follow-up period. Lesion status will be evaluated at 3, 6, 9, and 12 months to determine treatment efficacy.
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 27 Mar 2026.
- Results publication: PubMed 20739697Paris S, Meyer-Lueckel H. Infiltrants inhibit progression of natural caries lesions in vitro. J Dent Res. 2010 Nov;89(11):1276-80. doi: 10.1177/0022034510376040. Epub 2010 Aug 25.
- Results publication: PubMed 22257664Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) from this study will be shared in a de-identified form. Data will be made available upon reasonable request to the corresponding author after publication of the primary results. Access will be granted following approval of a data use agreement and ethics compliance.
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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.
Gizem Tıraşçı, Research ass. study chair
Inonu 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 Fluoride Varnish in people with Dental Caries and Tooth Demineralization, run by Sacide Duman 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 3 inclusion and 4 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 27 Mar 2026. 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?
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?
Caries Lesion Progression (time frame: 12 months). 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 NCT07112963, which also lists 2 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 27 Mar 2026.