Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
September 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 2, 2014
September 1, 2012
3 years
August 29, 2012
November 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
06, 12, 18, 24, 30 and 36 months
Secondary Outcomes (1)
Marginal adaptation
06, 12, 18, 24, 30 and 36 months
Study Arms (2)
Three adhesive coats
EXPERIMENTALConsecutive application of three one-bottle adhesive coats
Two adhesive coats
ACTIVE COMPARATORConsecutive application of two one-bottle adhesive coats
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Presence of two or more pairs of caries lesions in occlusal or occluso-approximal surfaces of primary molars
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry of Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil
Related Publications (5)
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.
PMID: 15279481BACKGROUNDHashimoto 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.
PMID: 15159072BACKGROUNDHashimoto 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.
PMID: 19904824BACKGROUNDPashley 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.
PMID: 14981122BACKGROUNDHashimoto 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.
PMID: 11820372BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 29, 2012
First Posted
September 7, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
December 2, 2014
Record last verified: 2012-09