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

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ClinicalTrials.gov Identifier: NCT01680289
Recruitment Status : Unknown
Verified September 2012 by Marlus Roberto Rodrigues Cajazeira, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : September 7, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Marlus Roberto Rodrigues Cajazeira, Universidade Federal do Rio de Janeiro

Tracking Information
First Submitted Date  ICMJE August 29, 2012
First Posted Date  ICMJE September 7, 2012
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Survival rate [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
Marginal adaptation [ Time Frame: 06, 12, 18, 24, 30 and 36 months ]
Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Caries
  • Secondary Dental Caries
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Three adhesive coats
    Consecutive application of three one-bottle adhesive coats
    Intervention: Procedure: Two adhesive coats
  • Active Comparator: Two adhesive coats
    Consecutive application of two one-bottle adhesive coats
    Intervention: Procedure: Three adhesive coats
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 3, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680289
Other Study ID Numbers  ICMJE Adhesive1
PRIMEBOND21 ( Registry Identifier: Primebond )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marlus Roberto Rodrigues Cajazeira, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Universidade Federal do Rio de Janeiro
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP