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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Universidade Federal do Rio de Janeiro
Sponsor:
Information provided by (Responsible Party):
Marlus Roberto Rodrigues Cajazeira, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01680289
First received: August 29, 2012
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Dental Caries
Secondary Dental Caries
Procedure: Three adhesive coats
Procedure: Two adhesive coats

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Survival rate [ Time Frame: 06, 12, 18, 24, 30 and 36 months ] [ Designated as safety issue: No ]
    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:
  • Marginal adaptation [ Time Frame: 06, 12, 18, 24, 30 and 36 months ] [ Designated as safety issue: No ]
    Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 a similar period, 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 three layers will be photopolymerized by 10 seconds with a LED photoactivation unit.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680289

Contacts
Contact: Marlus R Cajazeira, MsC 55-21-8383-2492 marlus.cajazeira@gmail.com
Contact: Lucianne Cople Maia, PhD 55-9994-3131 rorefa@gmail.com

Locations
Brazil
School of Dentistry of Federal University of Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21941-617
Contact: Lucianne Cople Maia, PHD    55-21-9994-3131    rorefa@gmail.com   
Contact: Marlus Cajazeira, MSC    55-21-8383-2492    marlus.cajazeira@gmail.com   
Principal Investigator: Marlus RR Cajazeira, MSC         
Sub-Investigator: Lucianne Cople Maia, PHD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Marlus Roberto Rodrigues Cajazeira, Assistant Professor, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01680289     History of Changes
Other Study ID Numbers: Adhesive1, PRIMEBOND21
Study First Received: August 29, 2012
Last Updated: September 3, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal do Rio de Janeiro:
Dentin bonding agents
Composite restorations
Dental restoration failure

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 18, 2014