Effectiveness of Sealing Dental Caries
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 22, 2015
October 1, 2015
5 months
October 19, 2015
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
36 months after the intervention
Secondary Outcomes (1)
Longevity of resin composite used as sealants to restore dental caries
36 months after the intervention
Study Arms (2)
Non-invasive resin based caries sealing
EXPERIMENTALApplication of resin based sealant after acid etching of carious occlusal surface
Invasive resin based restoration
ACTIVE COMPARATORApplication of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars
You may not qualify if:
- Patients with systemic diseases; patient' guardians who did not consent with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postgraduate student
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 22, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
February 1, 2017
Last Updated
October 22, 2015
Record last verified: 2015-10