Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
Overview
- Phase
- Not Applicable
- Intervention
- Fluoride varnish
- Conditions
- Caries; Initial
- Sponsor
- Hue University of Medicine and Pharmacy
- Enrollment
- 114
- Locations
- 2
- Primary Endpoint
- Development of new caries lesion
- Status
- Recruiting
- Last Updated
- 2 years ago
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.
Investigators
Le Van Nhat Thang
DDS, PhD, Principal Investigator
Hue University of Medicine and Pharmacy
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
- •\[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\].
- •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.
Arms & Interventions
Fluoride varnish group
5% sodium fluoride varnish, 3M, USA
Intervention: Fluoride varnish
Conventional etch and rinse sealant group
Resin-based composite sealant, 3M, USA
Intervention: Conventional etch and rinse sealant
Self-etch sealant group
Self-etch primed sealant, Shofu, Japan
Intervention: Self-etch sealant
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Sealants retention(12 months)
- Quality of sealants(12 months)