Early Treatments for Preventing Occlusal Caries Lesions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluoride varnish group 5% sodium fluoride varnish, 3M, USA |
Drug: Fluoride varnish
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
Other Names:
|
| Experimental: Conventional etch and rinse sealant group Resin-based composite sealant, 3M, USA |
Drug: Conventional etch and rinse sealant
Thirty-eight permanent molars will receive conventional etch and rinse sealant
Other Names:
|
| Active Comparator: Self-etch sealant group Self-etch primed sealant, Shofu, Japan |
Drug: Self-etch sealant
Thirty-eight permanent molars will receive self-etch sealant
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Development of new caries lesion [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 [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 [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 [12 months]
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Secondary Outcome Measures
- Sealants retention [3 months]
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.
- Sealants retention [6 months]
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.
- Sealants retention [9 months]
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.
- Sealants retention [12 months]
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.
- Quality of sealants [3 months]
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
- Quality of sealants [6 months]
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
- Quality of sealants [9 months]
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
- Quality of sealants [12 months]
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Eligibility Criteria
Criteria
Inclusion Criteria:
For children:
-
Children presenting with good general health and cooperative behavior.
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Children having early caries lesions in a permanent molar (first or second).
-
Parents signed informed consent.
For permanent molars:
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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].
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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:
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Any allergy reported by the parents.
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Children unable to return for recall visits.
For permanent molars:
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Teeth with occlusal surfaces completely covered by the gingival tissue.
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Teeth with hypoplastic defects, restorations, or sealants.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hue University of Medicine and Pharmacy | Hue | Thua Thien Hue | Vietnam | 49120 |
| 2 | Phu Vang Hospital | Phu Vang | Thua Thien Hue | Vietnam | 49900 |
Sponsors and Collaborators
- Hue University of Medicine and Pharmacy
Investigators
- Principal Investigator: Van Nhat Thang Le, DDS, PhD, Hue University of Medicine and Pharmacy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H2023/012