Early Treatments for Preventing Occlusal Caries Lesions

N/AActive Not RecruitingNCT05969756

Hue University of Medicine and Pharmacy114 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Caries; Initial Occlusal Caries Caries,Dental

Interventions

Fluoride varnishDRUG

Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months

Conventional etch and rinse sealantDRUG

Thirty-eight permanent molars will receive conventional etch and rinse sealant

Self-etch sealantDRUG

Thirty-eight permanent molars will receive self-etch sealant

Eligibility

Sex: ALLMin age: 5 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For children: 1. Children presenting with good general health and cooperative behavior. 2. Children having early caries lesions in a permanent molar (first or second). 3. Parents signed informed consent. For permanent molars: 1. Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\]. 2. 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: 1. Any allergy reported by the parents. 2. Children unable to return for recall visits. For permanent molars: 1. Teeth with occlusal surfaces completely covered by the gingival tissue. 2. Teeth with hypoplastic defects, restorations, or sealants.

Locations (2)

Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, Vietnam

Phu Vang Hospital

Phú Vang, Thừa Thiên Huế Province, Vietnam

Outcomes

Primary Outcomes

Development of new caries lesion

ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 9 months

Data from ClinicalTrials.gov

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