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
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Procedure: Rubber dam isolation Procedure: Relative isolation||Not Applicable|
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  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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
Active Comparator: Rubber dam isolation
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
Procedure: Rubber dam isolation
Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration
- 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)
- 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).
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
|Contact: Daniela P Raggio, Professorfirstname.lastname@example.org|
|University of Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 05508900|
|Contact: Isabel C Olegario, PhD +5515997773251 email@example.com|
|Principal Investigator:||Daniela P Raggio, PhD||University of Sao Paulo|
|Study Director:||Isabel C Olegário, PhD||University of São Paulo|