Early Treatments for Preventing Occlusal Caries Lesions

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars

Conditions
-----------------
Caries; Initial, Occlusal Caries, Caries,Dental

Intervention / Treatment
-----------------
* Drug: Fluoride varnish
* Drug: Conventional etch and rinse sealant
* Drug: Self-etch sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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]. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride varnish group<br>5% sodium fluoride varnish, 3M, USA | Drug: Fluoride varnish<br>* Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months<br>* Other names: 3M™ Clinpro™ White Varnish;|
| Experimental: Conventional etch and rinse sealant group<br>Resin-based composite sealant, 3M, USA | Drug: Conventional etch and rinse sealant<br>* Thirty-eight permanent molars will receive conventional etch and rinse sealant<br>* Other names: 3M™ Clinpro™ Sealant;|
| Active Comparator: Self-etch sealant group<br>Self-etch primed sealant, Shofu, Japan | Drug: Self-etch sealant<br>* Thirty-eight permanent molars will receive self-etch sealant<br>* Other names: Beautisealant;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of new caries lesion | ICDAS was considered 0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion | 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 | 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 | 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early caries lesions, sealants, erupting molars