Effectiveness of Sealing Dental Caries
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-invasive resin based caries sealing
Invasive resin based restoration
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars
Exclusion Criteria:
- Patients with systemic diseases; patient' guardians who did not consent with the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-invasive resin based caries sealing
Invasive resin based restoration
Arm Description
Application of resin based sealant after acid etching of carious occlusal surface
Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface
Outcomes
Primary Outcome Measures
Proportion of radiographic caries progression in the test group in comparison with the control group
Digital bitewing radiographs were taken at baseline and repeated after 6, 12, 24 and 36-months. The radiographical scoring system that will be used is: 1) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
Secondary Outcome Measures
Longevity of resin composite used as sealants to restore dental caries
Clinical evaluation will be performed through clinical examination after 6, 12, 24 and 36-months. The USPHS criteria for evaluating the marginal integrity of the restoration will be used. Clinical scores: Alfa - Restoration showing continuity with the anatomical shape ; Bravo - Restoration discontinuous with the anatomical shape , but the loss of material is not enough to expose the floor of the cavity; Charlie - Restoration discontinuous with the anatomical shape and the loss of material is sufficient to expose the floor of the cavity; and Delta - mobile Restoration fractured or lost.
Full Information
NCT ID
NCT02584218
First Posted
October 19, 2015
Last Updated
October 20, 2015
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University
1. Study Identification
Unique Protocol Identification Number
NCT02584218
Brief Title
Effectiveness of Sealing Dental Caries
Official Title
Effectiveness of Sealing Dental Caries: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to evaluate, through a controlled clinical randomized study, the effectiveness of sealing carious lesions with composite resin in primary molars. For this, healthy children (n=100) with caries lesion reaching to the middle third of the dentin of primary molars, will be submitted to different treatments to remove the lesions. These patients will be randomly allocated in the following treatment groups: (1) cavity sealing (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries removal and Invasive resin based restoration. The clinical and radiographic success of the treatment groups will be verified by periodic examination of the restorations by USPHS criteria and radiographic subtraction, respectively, which will be checked progression or not of injury. The researcher responsible for these assessments will be blind to the study, whose evaluations will occur after 6, 12, 24 and 36 months of treatment.
Detailed Description
The present study will be carried out as a randomized clinical study. Primary, occlusal caries lesions in children, aged 3-8 years old will be treated by non-invasive resin based sealing (n= 50) or resin based restoration (n=50). Randomization between sealing and restoration (1:1) was made by for a resercher at the Federal University of Rio de Janeiro and kept at the clinics in sealed envelopes. The treatments will be examined clinically and radiographically after 6, 12, 24 and 36 years. The treatments are performed and controlled by only one practitioner (the main reseacher of this study) from the Federal University of Rio de Janeiro, Brazil.
Sealing: The dentist will use a resin based sealing, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from the Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.
Restoration: The dentist will use preparation design and a resin based resin restoration, and follow their usual clinical procedures (partial caries removal) based on the instructions from the manufacturer and the guidelines from Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.
The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of children, or treatment related factors for assessing of statistically significant correlations.
The influence of each factor on the longevity and need for retreatment of occlusal sealants and restorations, will be assessed using apropriate analyses for statistical treatment of data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive resin based caries sealing
Arm Type
Experimental
Arm Description
Application of resin based sealant after acid etching of carious occlusal surface
Arm Title
Invasive resin based restoration
Arm Type
Active Comparator
Arm Description
Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface
Intervention Type
Procedure
Intervention Name(s)
Non-invasive resin based caries sealing
Other Intervention Name(s)
Sealing dental caries
Intervention Description
The dentists use resin based sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
Intervention Type
Procedure
Intervention Name(s)
Invasive resin based restoration
Other Intervention Name(s)
Restoration
Intervention Description
The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
Primary Outcome Measure Information:
Title
Proportion of radiographic caries progression in the test group in comparison with the control group
Description
Digital bitewing radiographs were taken at baseline and repeated after 6, 12, 24 and 36-months. The radiographical scoring system that will be used is: 1) Regression in depth of lesion (success) 2: Unchanged depth of lesion (success) 3: Progression in depth of lesion (failure)
Time Frame
36 months after the intervention
Secondary Outcome Measure Information:
Title
Longevity of resin composite used as sealants to restore dental caries
Description
Clinical evaluation will be performed through clinical examination after 6, 12, 24 and 36-months. The USPHS criteria for evaluating the marginal integrity of the restoration will be used. Clinical scores: Alfa - Restoration showing continuity with the anatomical shape ; Bravo - Restoration discontinuous with the anatomical shape , but the loss of material is not enough to expose the floor of the cavity; Charlie - Restoration discontinuous with the anatomical shape and the loss of material is sufficient to expose the floor of the cavity; and Delta - mobile Restoration fractured or lost.
Time Frame
36 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars
Exclusion Criteria:
Patients with systemic diseases; patient' guardians who did not consent with the study.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Sealing Dental Caries
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