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Isolation of the Operative Field Influences the Survival Rate of Composite Restorations (IsolationC3)

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ClinicalTrials.gov Identifier: NCT03733522
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Prócida Raggio, University of Sao Paulo

Brief Summary:
The aim of this study was to evaluate the survival of direct composite resin restorations in primary molars using different methods of isolation of the operative field: absolute isolation (local anesthesia, use of dental clamp and rubber dam) and relative isolation (cotton rollers and saliva ejector) by a randomized clinical trial. Two hundred (200) restorations will be performed on children aged 4 to 10 years who present at least one dentin caries lesion or restoration needing replacement, without pulp involvement in a primary tooth. The treatments will be performed in the dental clinic of the University of São Paulo (FOUSP) by trained operators. The teeth will be randomized between the groups: Absolute Isolation (AI) and Relative Isolation (IR) and restored with composite resin (Scotchbond Universal Adhesive adhesive system and Filtek BulkFill composite resin - 3M ESPE) stratified by surface (single or multi surface). Restoration evaluation will be performed after 6, 12, 18, and 24 months by a blind, trained and calibrated examiner. As a primary outcome, the survival of the restorations will be evaluated. The secondary outcomes involve the procedure time (in minutes), professional and material cost (in Brazilian reais), as well as the cost-effectiveness of the restorations and the discomfort reported by the patient (measured using the Wong-Baker scale). The Kaplan-Meier survival analysis and log-rank test will be applied to the survival of the restoration. All variables will be modeled and compared with a Cox regression model of shared fragility. The discomfort reported by the patient will be analyzed by Ordinal Logistic Regression (α = 5%).

Condition or disease Intervention/treatment Phase
Dental Caries in Children Procedure: Rubber dam isolation Procedure: Relative isolation Not Applicable

Detailed Description:

Objective:

The aim of this study is to evaluate the survival of direct composite resin restorations in primary molars using different methods for isolation of the operative field: absolute isolation (local anesthesia, use of dental clamp and rubber dam) and relative isolation (cotton rollers and saliva ejector) by a randomized clinical trial.

Materials and Methods:

Two hundred (200) restorations will be performed on children aged 4 to 10 years who present at least one dentin caries lesion or restoration needing replacement, without pulp involvement in a primary tooth. The treatments will be performed in the dental clinic of the University of São Paulo (FOUSP) by trained operators. The teeth will be randomized between the groups: Absolute Isolation (AI) and Relative Isolation (IR) and restored with composite resin (Scotchbond Universal Adhesive adhesive system and Filtek BulkFill composite resin - 3M ESPE) stratified by surface (single or multi surface).

Restoration evaluation will be performed after 6, 12, 18, and 24 months by a blind, trained and calibrated examiner.

The sample calculation was performed based on the primary outcome of the randomized clinical trial, which is the longevity of composite resin restorations in deciduous teeth. For this calculation, a 3-year failure rate of approximately 5% for composite resin restorations reported by a systematic review [5] was considered. Considering the hypothesis of non-inferiority between the groups and an inferiority limit of 10% between the groups, we reached the number of 118 restorations. As a child can contribute with more than one restoration, 40% was added to this value (n = 166). 20% for possible sample losses was added to this number, a minimum of 200 restorations were reached.

As a primary outcome, the survival of the restorations will be evaluated. The secondary outcomes involve the procedure time (in minutes), professional and material cost (in Brazilian reais), as well as the cost-effectiveness of the restorations and the discomfort reported by the patient (measured using the Wong-Baker scale).

The Kaplan-Meier survival analysis and log-rank test will be applied to the survival of the restoration. All variables will be modeled and compared with a Cox regression model of shared fragility. The discomfort reported by the patient will be analyzed by Ordinal Logistic Regression (α = 5%).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Only the evaluator of the restorations will be blind to the type of treatment (absolute or relative isolation). As the procedures are different, it will not be possible to blind operators and patients.
Primary Purpose: Treatment
Official Title: Does the Isolation of the Operative Field Influence the Survival Rate of Bulkfill Composite Restorations in Primary Teeth
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Active Comparator: Rubber dam isolation

Absolute isolation

  • local anesthesia
  • use of dental clamp and rubber dam
  • restoration using Universal Adhesive in a self etch mode (Single Bond Universal - 3M ESPE) and bulkfill composite resin (Filtek Bulkfill - 3M ESPE)
Procedure: Relative isolation
No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration

Experimental: Relative isolation

Relative isolation

  • no local anesthesia
  • use of cotton roll and saliva ejector
  • restoration using Universal Adhesive in a self etch mode (Single Bond Universal - 3M ESPE) and bulkfill composite resin (Filtek Bulkfill - 3M ESPE)
Procedure: Rubber dam isolation
Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration




Primary Outcome Measures :
  1. Survival of the restorations [ Time Frame: Every 6 months up to 36 months ]

    The restorations will be evaluated according to the Roeleveld et al., 2006 criteria and World Dental Federation (FDI) criteria.

    Roeleveld et al. codes success (0-10) or failure (11-50). FDI criteria codes succes 1 to 3 and failure 4 and 5 (any category)



Secondary Outcome Measures :
  1. Child self-reported discomfort (0-5) [ Time Frame: Immediately after treatment (in the same appointment) ]
    Wong-Baker Facial scale (Wong; Baker, 1998) from 0 to 5. The higher the score, higher the child self-reported discomfort.

  2. Time spent during treatment (in minutes) [ Time Frame: Immediately after treatment (in the same appointment) ]
    The total time spent in each restorative session will be recorded in minutes.

  3. Procedure cost (in brazilian reais - R$) [ Time Frame: Immediately after treatment (in the same appointment) ]
    Direct costs - all materials used in each procedure will be recorded. The average price of three different places in Brazilian market will be used (in Brazilian Reais).

  4. Incremental Cost (in brazilian reais) [ Time Frame: Every 12 months up to 36 months ]
    For the calculation of the final cost (Brazilian reais) of the treatment of each tooth will be used the result of the sum of the initial cost of the restorative procedure with the cost of repairs when necessary (incremental cost).



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • who have sought treatment in the University;
  • between 4 and 10 years of age;
  • with at least one dentin caries lesion without pulp involvement (ICCMS C score);
  • need for restoration replacement diagnosed by FDI criteria or CARS criteria;
  • absence of pulp involvement diagnosed by interproximal radiography (presence of dentin layer between the caries lesion and the pulp chamber).

Exclusion Criteria:

  • children whose parents did not agree to participate in the study:
  • children who did not agree to participate or had behavioral problems during the initial consultations.
  • signs or symptoms of pulp pathology: spontaneous pain, pulp exposure, abscess or fistula near the tooth to be included, mobility or presence of communication between the caries lesion and the pulp (evaluated by interproximal digital radiography of the diagnosis).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733522


Contacts
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Contact: Daniela P Raggio, Professor +551130917835 danielar@usp.br

Locations
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Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05508900
Contact: Isabel C Olegario, PhD    +5515997773251    isabel.costa@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Daniela P Raggio, PhD University of Sao Paulo
Study Director: Isabel C Olegário, PhD University of São Paulo

Publications of Results:
Other Publications:
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Responsible Party: Daniela Prócida Raggio, Associated Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03733522     History of Changes
Other Study ID Numbers: IsolationFOUSP
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs