Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
Primary Purpose
Dental Caries, Secondary Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Three adhesive coats
Two adhesive coats
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dentin bonding agents, Composite restorations, Dental restoration failure
Eligibility 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
Sites / Locations
- School of Dentistry of Federal University of Rio de JaneiroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Three adhesive coats
Two adhesive coats
Arm Description
Consecutive application of three one-bottle adhesive coats
Consecutive application of two one-bottle adhesive coats
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Marginal adaptation
Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)
Full Information
NCT ID
NCT01680289
First Posted
August 29, 2012
Last Updated
November 25, 2014
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT01680289
Brief Title
Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Secondary Dental Caries
Keywords
Dentin bonding agents, Composite restorations, Dental restoration failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Three adhesive coats
Arm Type
Experimental
Arm Description
Consecutive application of three one-bottle adhesive coats
Arm Title
Two adhesive coats
Arm Type
Active Comparator
Arm Description
Consecutive application of two one-bottle adhesive coats
Intervention Type
Procedure
Intervention Name(s)
Three adhesive coats
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Two adhesive coats
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival rate
Description
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.
Time Frame
06, 12, 18, 24, 30 and 36 months
Secondary Outcome Measure Information:
Title
Marginal adaptation
Description
Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)
Time Frame
06, 12, 18, 24, 30 and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marlus R Cajazeira, MsC
Phone
55-21-8383-2492
Email
marlus.cajazeira@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucianne Cople Maia, PhD
Phone
55-9994-3131
Email
rorefa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlus RR Cajazeira, MsD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucianne Cople Maia, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eduardo M da Silva, PhD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alessandro D Loguércio, PhD
Organizational Affiliation
Universidade Estadual de Ponta Grossa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michelle M Amari, MsD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Study Director
Facility Information:
Facility Name
School of Dentistry of Federal University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-617
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucianne Cople Maia, PHD
Phone
55-21-9994-3131
Email
rorefa@gmail.com
First Name & Middle Initial & Last Name & Degree
Marlus Cajazeira, MSC
Phone
55-21-8383-2492
Email
marlus.cajazeira@gmail.com
First Name & Middle Initial & Last Name & Degree
Marlus RR Cajazeira, MSC
First Name & Middle Initial & Last Name & Degree
Lucianne Cople Maia, PHD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15279481
Citation
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.
Results Reference
background
PubMed Identifier
15159072
Citation
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.
Results Reference
background
PubMed Identifier
19904824
Citation
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.
Results Reference
background
PubMed Identifier
14981122
Citation
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.
Results Reference
background
PubMed Identifier
11820372
Citation
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.
Results Reference
background
Links:
URL
http://www.odontologia.ufrj.br
Description
School of Dentistry of Federal University of Rio de Janeiro web site
Learn more about this trial
Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
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