Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE December 1, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03733522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • 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.
  • 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.
  • Procedure cost (in brazilian reais - R$) [ Time Frame: Immediately after treatment (in the same appointment) ]
    Direct costs - all materials used in each procedure will be recorded. The average price of three different places in Brazilian market will be used (in Brazilian Reais).
  • Incremental Cost (in brazilian reais) [ Time Frame: Every 12 months up to 36 months ]
    For the calculation of the final cost (Brazilian reais) of the treatment of each tooth will be used the result of the sum of the initial cost of the restorative procedure with the cost of repairs when necessary (incremental cost).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • Child self-reported discomfort (0-5) [ Time Frame: Immediately after treatment (in the same appointment) ]
    The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he or she felt during the treatment. This answer should be given solely by the child, which means, no parental or professional interferences. The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session. The higher the score, higher the child self-reported discomfort.
  • Time spent during treatment (in minutes) [ Time Frame: Immediately after treatment (in the same appointment) ]
    The total time spent in each restorative session will be recorded in minutes.
  • Procedure cost (in brazilian reais - R$) [ Time Frame: Immediately after treatment (in the same appointment) ]
    To calculate the professional cost, the total time spent in each restorative session will be multiplied by the average hourly rate of a dental surgeon, plus a 40% risk (R$ 50.08 / h), as well as the average income of an Auxiliary in Oral Health per hour plus 20% of insalubrity (R$ 28,62 / h), as governed by Federal Law no.3999 / 61. For the calculation of direct costs, the prices of the materials used in each procedure will also be considered. These values will be inferences of the market value obtained by average of different places that market the products in question, being updated during the time of the study. The time spent in each session will be timed by an assistant (who is not participating in the diagnostic or treatment exams) in order to enter into the cost-benefit analysis of the methods used in the research. It will also record the number of visits of each individual and the procedure done in each session, with their respective duration and materials used.
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isolation of the Operative Field Influences the Survival Rate of Composite Restorations
Official Title  ICMJE Does the Isolation of the Operative Field Influence the Survival Rate of Bulkfill Composite Restorations in Primary Teeth
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%).
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%).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dental Caries in Children
Intervention  ICMJE
  • Procedure: Rubber dam isolation
    Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration
  • Procedure: Relative isolation
    No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: Relative isolation
  • 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)
    Intervention: Procedure: Rubber dam isolation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daniela P Raggio, Professor +551130917835 danielar@usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03733522
Other Study ID Numbers  ICMJE IsolationFOUSP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Daniela Prócida Raggio, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniela P Raggio, PhD University of Sao Paulo
Study Director: Isabel C Olegário, PhD University of São Paulo
PRS Account University of Sao Paulo
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP