Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
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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. |
- 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.
- 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 |
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| Contact: Marlus R Cajazeira, MsC | 55-21-8383-2492 | marlus.cajazeira@gmail.com |
| Contact: Lucianne Cople Maia, PhD | 55-9994-3131 | rorefa@gmail.com |
| 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 | |
| Principal Investigator: | Marlus RR Cajazeira, MsD | Federal University of Rio de Janeiro |
| Study Chair: | Lucianne Cople Maia, PhD | Federal University of 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 Federal University of 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 June 18, 2013