Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars

Not Applicable

• Conditions: Dental Caries; Secondary Dental Caries
• Interventions: Procedure: Two adhesive coats; Procedure: Three adhesive coats

• Registration Number: NCT01680289
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

The aim of this study is to determinate the influence of an alternative adhesive application protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in primary molars.

Detailed Description

Adhesive systems based on total etch technique remains the most popular products among dental practitioners. These systems are based on the use of an acid conditioner to remove the smear layer and demineralize the enamel and dentin. After the removal of the conditioner by rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is applicated over the demineralized tissues. The polymerization of the adhesive monomers into microporosities created by acid conditioning forms the structure knowing as hybrid layer or resin-dentin interdifusion zone. A common problem related to total etch technique is the incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to enzymatic degradation. According to some laboratory studies, consecutive application of multiple adhesive coats results in quantitative and qualitative improvements in dental adhesion. In addition to increasing the values of bond strength to dentin, consecutive application of multiple adhesive layers enhances the infiltration of adehesive monomers through demineralized dentin, resulting in a more homogenous hybrid layer.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-29
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-07
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Presence of two or more pairs of caries lesions in occlusal or occluso-approximal surfaces of primary molars

Exclusion Criteria

• Systemic diseases in which dental treatment is a risk to patient's life
• Bruxism
• Orthodontic appliance
• Absence of occlusal contact in eligible teeth
• Signs and symptoms of pulp infflamation or necrosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Three adhesive coats	Two adhesive coats	Consecutive application of three one-bottle adhesive coats
Two adhesive coats	Three adhesive coats	Consecutive application of two one-bottle adhesive coats

Primary Outcome Measures

Name	Time	Method
Survival rate	06, 12, 18, 24, 30 and 36 months	Survival rate considering failure of restorations due: partial or complete loss of restorative material; marginal ditching; superficial or marginal discoloration; secondary caries; pulpal complications; wear of restorative material; tooth fracture.

Secondary Outcome Measures

Name	Time	Method
Marginal adaptation	06, 12, 18, 24, 30 and 36 months	Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)

Trial Locations

Locations (1)

School of Dentistry of Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil