Clinical trial NCT05969756: Early Treatments for Preventing Occlusal Caries Lesions
Official title: Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Caries; Initial
Occlusal Caries
Caries,Dental
Keywords: early caries lesions
sealants
erupting molars
Lead sponsor: Hue University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Development of new caries lesion
timeFrame: 3 months
measure: Development of new caries lesion
timeFrame: 6 months
measure: Development of new caries lesion
timeFrame: 9 months
measure: Development of new caries lesion
timeFrame: 12 months
Secondary outcomes:
measure: Sealants retention
timeFrame: 3 months
measure: Sealants retention
timeFrame: 6 months
measure: Sealants retention
timeFrame: 9 months
measure: Sealants retention
timeFrame: 12 months
measure: Quality of sealants
timeFrame: 3 months
measure: Quality of sealants
timeFrame: 6 months
measure: Quality of sealants
timeFrame: 9 months
measure: Quality of sealants
timeFrame: 12 months
Other outcomes:
Locations:
city: Hue
country: Vietnam
facility: Hue University of Medicine and Pharmacy
state: Thua Thien Hue
city: Phu Vang
country: Vietnam
facility: Phu Vang Hospital
state: Thua Thien Hue
Study officials:
affiliation: Hue University of Medicine and Pharmacy
name: Van Nhat Thang Le, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: