Clinical Trial of the Effect of Different Categories of Adhesive System

Phase 2

• Conditions: Dental Caries
• Interventions: Procedure: Dental restoration; Procedure: 2 step ER; Procedure: 3 step ER; Procedure: 2 step SE; Procedure: 1 step SE

• Registration Number: NCT02751970
• Lead Sponsor: Universidad de Valparaiso

Brief Summary

This study aims to evaluate the clinical effectiveness of contemporary resin-based adhesive systems by retention rate of resin restorations placed in non carious cervical lesions with four different adhesive strategies: 3 and 2 steps etch-and-rinse adhesive system, 2 and 1 step self-etch adhesive systems.

Detailed Description

The etch-and-rinse (3 and 2 steps) and self-etch (1 and 2 steps) adhesive systems allow the bond between the resins restorations with the dental substrates, but they have mechanism of action different.

The success of resin composite restorations is reliant upon adhesion to the underlying tooth via adhesive systems. The mechanism of adhesion to enamel and dentine could be involved for one hand, the etching the substrates with 30-40% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin 3 steps etch-and- rinse approach or 2 steps when to combine the primer and adhesive into one bottle. For another hand, the self- etch systems with acid monomers in their primer, allow conditioning the surface without phosphoric acid step. So, they consist of either a self-etching primer accompanied by an adhesive resin applied as a subsequent step (2 steps) or a self-etch adhesive, which does not require a separate primer (1 step).

Study Timeline

• Study Start: 2014-04
• Status Verified: 2016-04
• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Study First Posted: 2016-04-26
• Last Update Posted: 2016-04-26
• Primary Completion: 2016-05
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Good general health,
• Patients with acceptable oral hygiene level,
• Patients with at least 20 teeth under occlusion.
• Patients with at least four non-carious cervical lesions in four different teeth
• Patients with maximum of eight lesions that needed to be restored.
• These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both the enamel and dentin of vital teeth without mobility.

Exclusion Criteria

• Patients with extremely poor oral hygiene,
• Patients with severe or chronic periodontitis,
• Patients with heavy bruxism habits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 step ER & Dental restoration	2 step ER	Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step.
3 step ER & Dental restoration	3 step ER	Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin.
2 step SE & Dental restoration	2 step SE	Dental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin.
2 step SE & Dental restoration	Dental restoration	Dental restoration with etching the dental substrates with acidic primer, followed by the application of adhesive resin.
2 step ER & Dental restoration	Dental restoration	Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of an adhesive/primer step.
1 step SE & Dental restoration	1 step SE	Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.
3 step ER & Dental restoration	Dental restoration	Dental restoration with etching the dental substrates 35% phosphoric acid, followed by the application of a primer and subsequently an adhesive resin.
1 step SE & Dental restoration	Dental restoration	Dental restoration with etching and infiltrate the dental substrates with acidic primer/adhesive system.

Primary Outcome Measures

Name	Time	Method
Retention rate	one year	retention rate of the dental restorations
Secondary caries	one year	Secondary caries near and/or associated of the dental restorations

Secondary Outcome Measures

Name	Time	Method
Marginal integrity	one year	marginal integrity of the dental restorations
Marginal discoloration	one year	Marginal discoloration of the dental restorations
post-operative sensitivity	one year	dentin post-operative sensitivity

Trial Locations

Locations (1)

Universidad Valparaiso; 🇨🇱 Valparaiso, V region, Chile