Status:
ACTIVE_NOT_RECRUITING
Early Treatments for Preventing Occlusal Caries Lesions
Lead Sponsor:
Hue University of Medicine and Pharmacy
Conditions:
Caries; Initial
Occlusal Caries
Eligibility:
All Genders
5-14 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05969756
Start Date
July 31 2023
End Date
October 15 2024
Last Update
September 20 2024
Active Locations (2)
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1
Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, Vietnam, 49120
2
Phu Vang Hospital
Phú Vang, Thừa Thiên Huế Province, Vietnam, 49900