NCT01680289|Unknown
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Sponsor study identifier
Secondary identifiers
REGISTRY · Primebond
interventional
60
1 country
1
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2012
Actual (reported)September 7, 2012
Actual (reported)August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Marginal adaptation
06, 12, 18, 24, 30 and 36 months
Consecutive application of three one-bottle adhesive coats
Consecutive application of two one-bottle 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.
School of Dentistry of Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-617, Brazil
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.
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.
Marlus RR Cajazeira, MsD
Universidade Federal do Rio de Janeiro
Lucianne Cople Maia, PhD
Universidade Federal do Rio de Janeiro
Eduardo M da Silva, PhD
Universidade Federal Fluminense
Alessandro D Loguércio, PhD
Universidade Estadual de Ponta Grossa
First Submitted
August 29, 2012
First Posted
September 7, 2012
Study Start
August 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Primary Molars Restorations With Encapsulated or Hand-Mixed Glass Ionomer: Clinical Trial
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Michelle M Amari, MsD
Universidade Federal Fluminense
August 2015
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 2, 2014
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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