Back to resultsEarly Treatments for Preventing Occlusal Caries Lesions
Primary Purpose
Caries; Initial, Occlusal Caries, Caries,Dental
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Fluoride varnish
Conventional etch and rinse sealant
Self-etch sealant
Sponsored by
About this trial
This is an interventional treatment trial for Caries; Initial focused on measuring early caries lesions, sealants, erupting molars
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Hue University of Medicine and PharmacyRecruiting
- Phu Vang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Fluoride varnish group
Conventional etch and rinse sealant group
Self-etch sealant group
Arm Description
5% sodium fluoride varnish, 3M, USA
Resin-based composite sealant, 3M, USA
Self-etch primed sealant, Shofu, Japan
Outcomes
Primary Outcome Measures
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Development of new caries lesion
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Secondary Outcome Measures
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.
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.
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.
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.
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Quality of sealants
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Full Information
NCT ID
NCT05969756
First Posted
July 23, 2023
Last Updated
August 13, 2023
Sponsor
Hue University of Medicine and Pharmacy
1. Study Identification
Unique Protocol Identification Number
NCT05969756
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hue University of Medicine and Pharmacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries; Initial, Occlusal Caries, Caries,Dental
Keywords
early caries lesions, sealants, erupting molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoride varnish group
Arm Type
Experimental
Arm Description
5% sodium fluoride varnish, 3M, USA
Arm Title
Conventional etch and rinse sealant group
Arm Type
Experimental
Arm Description
Resin-based composite sealant, 3M, USA
Arm Title
Self-etch sealant group
Arm Type
Active Comparator
Arm Description
Self-etch primed sealant, Shofu, Japan
Intervention Type
Drug
Intervention Name(s)
Fluoride varnish
Other Intervention Name(s)
3M™ Clinpro™ White Varnish
Intervention Description
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
Intervention Type
Drug
Intervention Name(s)
Conventional etch and rinse sealant
Other Intervention Name(s)
3M™ Clinpro™ Sealant
Intervention Description
Thirty-eight permanent molars will receive conventional etch and rinse sealant
Intervention Type
Drug
Intervention Name(s)
Self-etch sealant
Other Intervention Name(s)
S-PRG filler-containing resin sealant, Beautisealant
Intervention Description
Thirty-eight permanent molars will receive self-etch sealant
Primary Outcome Measure Information:
Title
Development of new caries lesion
Description
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Time Frame
3 months
Title
Development of new caries lesion
Description
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Time Frame
6 months
Title
Development of new caries lesion
Description
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Time Frame
9 months
Title
Development of new caries lesion
Description
ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Sealants retention
Description
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
Title
Sealants retention
Description
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
Title
Sealants retention
Description
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
Title
Sealants retention
Description
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
12 months
Title
Quality of sealants
Description
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Time Frame
3 months
Title
Quality of sealants
Description
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Time Frame
6 months
Title
Quality of sealants
Description
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Time Frame
9 months
Title
Quality of sealants
Description
Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Van Nhat Thang Le, DDS, PhD
Phone
+84931199077
Email
lvnthang@hueuni.edu.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Van Nhat Thang Le, DDS, PhD
Organizational Affiliation
Hue University of Medicine and Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hue University of Medicine and Pharmacy
City
Hue
State/Province
Thua Thien Hue
ZIP/Postal Code
49120
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Thao Nguyen, MD, PhD
Email
stir@huemed-univ.edu.vn
Facility Name
Phu Vang Hospital
City
Phu Vang
State/Province
Thua Thien Hue
ZIP/Postal Code
49900
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Van Lich Tran, DDS
Email
tranvanlich85@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will plan to share information when finishing study
IPD Sharing Time Frame
Plan to complete study in 1 year and will share the data after get publication
Learn more about this trial
Early Treatments for Preventing Occlusal Caries Lesions
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