Early Treatments for Preventing Occlusal Caries Lesions

Caries,Dental Clinical Trial

Official title:

Clinical Effectiveness of Early Treatments for Preventing Occlusal Caries Lesions in Erupting Permanent Molars

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969756
• Other study ID #: H2023/012
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Hue University of Medicine and Pharmacy
• Contact: Van Nhat Thang Le, DDS, PhD
• Phone: +84931199077
• Email: lvnthang[@]hueuni.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Caries; Initial
• Dental Caries
• Occlusal Caries

Intervention

Drug:
• Fluoride varnish
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
• Conventional etch and rinse sealant
Thirty-eight permanent molars will receive conventional etch and rinse sealant
• Self-etch sealant
Thirty-eight permanent molars will receive self-etch sealant

Locations

Country	Name	City	State
Vietnam	Hue University of Medicine and Pharmacy	Hue	Thua Thien Hue
Vietnam	Phu Vang Hospital	Phu Vang	Thua Thien Hue

Sponsors (1)

Lead Sponsor	Collaborator
Hue University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS=1 was considered as new caries lesion	3 months
Primary	Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS=1 was considered as new caries lesion	6 months
Primary	Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS=1 was considered as new caries lesion	9 months
Primary	Development of new caries lesion	ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS=1 was considered as new caries lesion	12 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	9 months
Secondary	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.	12 months
Secondary	Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	3 months
Secondary	Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	6 months
Secondary	Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	9 months
Secondary	Quality of sealants	Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.	12 months