Clinical trial NCT01680289: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Secondary Dental Caries
Keywords: Dentin bonding agents
Composite restorations
Dental restoration failure
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival rate
timeFrame: 06, 12, 18, 24, 30 and 36 months
Secondary outcomes:
measure: Marginal adaptation
timeFrame: 06, 12, 18, 24, 30 and 36 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: School of Dentistry of Federal University of Rio de Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Marlus RR Cajazeira, MsD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Lucianne Cople Maia, PhD
role: STUDY_CHAIR
affiliation: Universidade Federal Fluminense
name: Eduardo M da Silva, PhD
role: STUDY_CHAIR
affiliation: Universidade Estadual de Ponta Grossa
name: Alessandro D Loguércio, PhD
role: STUDY_CHAIR
affiliation: Universidade Federal Fluminense
name: Michelle M Amari, MsD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.