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

Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Resin Restorations in Primary Molars - Randomized Controlled Clinical Study.

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries; Secondary Dental Caries
• Intervention / Treatment: Procedure: Two adhesive coats; Procedure: Three adhesive coats

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21941-617
    • Recruiting
    • School of Dentistry of Federal University of Rio de Janeiro
    • Contact: Lucianne Cople Maia, PHD; Phone Number: 55-21-9994-3131; Email: rorefa@gmail.com
    • Contact: Marlus Cajazeira, MSC; Phone Number: 55-21-8383-2492; Email: marlus.cajazeira@gmail.com
    • Principal Investigator: Marlus RR Cajazeira, MSC
    • Sub-Investigator: Lucianne Cople Maia, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three adhesive coats; Consecutive application of three one-bottle adhesive coats	Procedure: Two adhesive coats; After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after 20 seconds, the layers will be gently air-dried by 5 seconds. The two layers will be photopolymerized by 10 seconds with a LED photoactivation unit.
Active Comparator: Two adhesive coats; Consecutive application of two one-bottle adhesive coats	Procedure: Three adhesive coats; After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after a similar period a third layer will be applied over cavity walls. Again, after 20 seconds, the layers will be gently air-dried and photopolymerized by 10 seconds with a LED photoactivation unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	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.	06, 12, 18, 24, 30 and 36 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Marlus RR Cajazeira, MsD, Universidade Federal do Rio de Janeiro; Study Chair: Lucianne Cople Maia, PhD, Universidade Federal do Rio de Janeiro; Study Chair: Eduardo M da Silva, PhD, Universidade Federal Fluminense; Study Chair: Alessandro D Loguércio, PhD, Universidade Estadual de Ponta Grossa; Study Director: Michelle M Amari, MsD, Universidade Federal Fluminense

Publications and helpful links

General Publications

• Hashimoto M, Sano H, Yoshida E, Hori M, Kaga M, Oguchi H, Pashley DH. Effects of multiple adhesive coatings on dentin bonding. Oper Dent. 2004 Jul-Aug;29(4):416-23.
• Hashimoto M, De Munck J, Ito S, Sano H, Kaga M, Oguchi H, Van Meerbeek B, Pashley DH. In vitro effect of nanoleakage expression on resin-dentin bond strengths analyzed by microtensile bond test, SEM/EDX and TEM. Biomaterials. 2004 Nov;25(25):5565-74. doi: 10.1016/j.biomaterials.2004.01.009.
• Hashimoto M. A review--micromorphological evidence of degradation in resin-dentin bonds and potential preventional solutions. J Biomed Mater Res B Appl Biomater. 2010 Jan;92(1):268-80. doi: 10.1002/jbm.b.31535.
• Pashley DH, Tay FR, Yiu C, Hashimoto M, Breschi L, Carvalho RM, Ito S. Collagen degradation by host-derived enzymes during aging. J Dent Res. 2004 Mar;83(3):216-21. doi: 10.1177/154405910408300306.
• Hashimoto M, Ohno H, Kaga M, Sano H, Endo K, Oguchi H. The extent to which resin can infiltrate dentin by acetone-based adhesives. J Dent Res. 2002 Jan;81(1):74-8. doi: 10.1177/002203450208100116.

Helpful Links

• School of Dentistry of Federal University of Rio de Janeiro web site

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Composite restorations; Dental restoration failure; Dentin bonding agents
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Adhesive1; PRIMEBOND21 (Registry Identifier: Primebond)