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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
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 19, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Universidade Federal do Rio de Janeiro
    Collaborators
    Rio de Janeiro State University
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    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

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    Effectiveness of Sealing Dental Caries

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