Isolation of the Operative Field Influences the Survival Rate of Composite Restorations

NCT03733522 | Completed

• 1 other identifier: IsolationFOUSP
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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%).

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• Survival of the restorations

  The restorations will be evaluated according to the Roeleveld et al., 2006 criteria. Roeleveld et al. codes success (0-10) or failure (11-50).

  Every 6 months up to 24 months

Secondary Outcomes (4)

• Child self-reported discomfort (0-5)

  Immediately after treatment (in the same appointment)

• Time spent during treatment (in minutes)

  Immediately after treatment (in the same appointment)

• Procedure cost (in brazilian reais - R$)

  Immediately after treatment (in the same appointment)

• Incremental Cost (in brazilian reais)

  Every 12 months up to 24 months

Study Arms (2)

Rubber dam isolation

ACTIVE COMPARATOR

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

Relative isolation

EXPERIMENTAL

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

Interventions

Rubber dam isolation PROCEDURE

Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration

Relative isolation

Relative isolation PROCEDURE

No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration

Rubber dam isolation

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508900, Brazil

Location

Related Publications (4)

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 17518963 BACKGROUND

• 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.

  PMID: 29322626 BACKGROUND

• 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.

  PMID: 17140533 RESULT

Study Officials

• Daniela P Raggio, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Isabel C Olegário, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: November 7, 2018
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)