Caries; InitialNCT05969756
Early Treatments for Preventing Occlusal Caries Lesions
A study testing Fluoride varnish, Conventional etch and rinse sealant and Self-etch sealant in people with Caries; Initial and Occlusal Caries, run by Hue University of Medicine and Pharmacy at 2 sites in Vietnam.
Trial summary
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Initial, Occlusal Caries, Caries,Dental
- What is being tested?
- Fluoride varnish, Conventional etch and rinse sealant and Self-etch sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesVietnam
- Study dates
- 31 Jul 2023to 15 Oct 2024
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For children:
- Children presenting with good general health and cooperative behavior.
- Children having early caries lesions in a permanent molar (first or second).
- Parents signed informed consent.
- For permanent molars:
- Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. [Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8].
- Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). [Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9].
Who cannot join
- For children:
- Any allergy reported by the parents.
- Children unable to return for recall visits.
- For permanent molars:
- Teeth with occlusal surfaces completely covered by the gingival tissue.
- Teeth with hypoplastic defects, restorations, or sealants.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, 49120
Phu Vang Hospital
Phú Vang, Thừa Thiên Huế Province, 49900
About this study
Official title: Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
- Conditions
- Caries; Initial, Occlusal Caries, Caries,Dental
- Being tested
- Fluoride varnish, Conventional etch and rinse sealant, Self-etch sealant
- Keywords
- early caries lesions, sealants, erupting molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
Also called 3M™ Clinpro™ White Varnish
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
Conventional etch and rinse sealantDrug
Also called 3M™ Clinpro™ Sealant
Thirty-eight permanent molars will receive conventional etch and rinse sealant
Self-etch sealantDrug
Also called S-PRG filler-containing resin sealant, Beautisealant
Thirty-eight permanent molars will receive self-etch sealant
| Study group | Role | What they receive |
|---|---|---|
| Fluoride varnish group | Experimental | 5% sodium fluoride varnish, 3M, USA Receives: Drug: Fluoride varnish |
| Conventional etch and rinse sealant group | Experimental | Resin-based composite sealant, 3M, USA Receives: Drug: Conventional etch and rinse sealant |
| Self-etch sealant group | Active comparator | Self-etch primed sealant, Shofu, Japan Receives: Drug: Self-etch sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Measured: 3 months
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Measured: 6 months
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Measured: 9 months
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Measured: 12 months
Secondary outcomes (8)
Sealants retention
Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
Measured: 3 months
Sealants retention
Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
Measured: 6 months
Sealants retention
Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
Measured: 9 months
Sealants retention
Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface.
Measured: 12 months
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Measured: 3 months
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Measured: 6 months
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Measured: 9 months
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
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 posted1 Aug 2023
- Study start31 Jul 2023
- Primary completion10 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; InitialStudies 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
- This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Van Nhat Thang, Hue University of Medicine and Pharmacy
- Investigators
- Van Nhat Thang Le, DDS, PhD, Principal investigator, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969756
- Sponsor's protocol ID
- H2023/012
- Status last verified
- May 2026
- First submitted
- 23 Jul 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will plan to share information when finishing study
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
- ClinicalTrials.gov ID
- NCT05969756
- Acronym / sponsor ID
- H2023/012
- Conditions
- Caries; Initial, Occlusal Caries, Caries,Dental
- Keywords
- early caries lesions, sealants, erupting molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 1 Aug 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.
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.
| Arm | Type | Receives |
|---|---|---|
| Fluoride varnish group | Experimental | Drug: Fluoride varnish5% sodium fluoride varnish, 3M, USA |
| Conventional etch and rinse sealant group | Experimental | Drug: Conventional etch and rinse sealantResin-based composite sealant, 3M, USA |
| Self-etch sealant group | Active comparator | Drug: Self-etch sealantSelf-etch primed sealant, Shofu, Japan |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children presenting with good general health and cooperative behavior.
- Children having early caries lesions in a permanent molar (first or second).
- Parents signed informed consent.
- Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. [Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8].
- Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). [Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9].
Key exclusion criteria (6 listed)
- Any allergy reported by the parents.
- Children unable to return for recall visits.
- Teeth with occlusal surfaces completely covered by the gingival tissue.
- Teeth with hypoplastic defects, restorations, or sealants.
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: 3M™ Clinpro™ White VarnishThirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months | Drug | Fluoride varnish group |
| Conventional etch and rinse sealantAlso: 3M™ Clinpro™ SealantThirty-eight permanent molars will receive conventional etch and rinse sealant | Drug | Conventional etch and rinse sealant group |
| Self-etch sealantAlso: S-PRG filler-containing resin sealant, BeautisealantThirty-eight permanent molars will receive self-etch sealant | Drug | Self-etch sealant group |
Primary outcome
Development of new caries lesion
Time frame: 3 months
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
Time frame: 6 months
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
Time frame: 9 months
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
Time frame: 12 months
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
8 secondary outcomes
Sealants retention
Time frame: 3 months
Sealants retention
Time frame: 6 months
Sealants retention
Time frame: 9 months
Sealants retention
Time frame: 12 months
Quality of sealants
Time frame: 3 months
Quality of sealants
Time frame: 6 months
Quality of sealants
Time frame: 9 months
Quality of sealants
Time frame: 12 months
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 14 May 2026.
- Individual participant dataSharing planned: Yes. Will plan to share information when finishing study
Related trials for Caries; Initial
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
White Spot Lesion of Tooth, Orthodontic Treatment
Active, not recruiting
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Dental Caries, Fissure Sealant
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.
Van Nhat Thang Le, DDS, PhD principal investigator
Hue University of Medicine and Pharmacy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride varnish, Conventional etch and rinse sealant and Self-etch sealant in people with Caries; Initial and Occlusal Caries, run by Hue University of Medicine and Pharmacy at 2 sites in Vietnam.
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 7 inclusion and 6 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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?
Development of new caries lesion (time frame: 3 months). The study lists 4 primary outcomes in all. 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 14 May 2026.