Clinical trial NCT03733522: Isolation of the Operative Field Influences the Survival Rate of Composite Restorations
Official title: Does the Isolation of the Operative Field Influence the Survival Rate of Bulkfill Composite Restorations in Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 93
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. All composite 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:

All composite 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%).

Eligibility 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).

Primary outcomes:
measure: Survival of the restorations
timeFrame: Every 6 months up to 24 months
Secondary outcomes:
measure: Child self-reported discomfort (0-5)
timeFrame: Immediately after treatment (in the same appointment)
measure: Time spent during treatment (in minutes)
timeFrame: Immediately after treatment (in the same appointment)
measure: Procedure cost (in brazilian reais - R$)
timeFrame: Immediately after treatment (in the same appointment)
measure: Incremental Cost (in brazilian reais)
timeFrame: Every 12 months up to 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Isabel C Olegário, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
citation: Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
citation: Chisini LA, Collares K, Cademartori MG, de Oliveira LJC, Conde MCM, Demarco FF, Correa MB. Restorations in primary teeth: a systematic review on survival and reasons for failures. Int J Paediatr Dent. 2018 Mar;28(2):123-139. doi: 10.1111/ipd.12346. Epub 2018 Jan 10.
citation: Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.