NCT04565938|UnknownPhase 2
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Sponsor study identifier
interventional
32
1 country
1
Study Start
July 21, 2020
Actual (reported)Primary Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 10, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market. The aim of this randomized controlled clinical trial was to test the hypothesis that a one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive. Materials and methods: Thirty two patients with 96 non-carious cervical lesions received composite-resin restorations (Tetric Evo Ceram - Ivoclar/Vivadent), which were bonded either with a one-step self-etch adhesive (AdheSE One - Ivoclar/Vivadent) with or without enamel etching, or with a two-step etch-and-rinse adhesive (ExiTE - Ivoclar/Vivadent). All restorations were evaluated by two examiners at baseline, 6, 12, 18 and 24 months regarding retention, caries recurrence, marginal integrity and discoloration. Retention loss, severe marginal defects and/or discoloration that needed intervention (repair or replacement) and occurrence of caries, were considered as clinical failures. A logistic regression analysis with generalized estimating equations was used to account for the clustered data (three restorations per patient).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 10, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 21, 2020
Actual (reported)September 22, 2020
Actual (reported)September 28, 2020
Actual (reported)October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 10, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Retention of the restorations
percentage of retained restorations
2 years
Recurrent caries during examination
percentage of lesion with recurrent caries
2 years
Marginal adaptation of the restorations
Measured in μm
2 years
Marginal discolouration of the restorations
percentage of stained lesions
2 years
Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive with enamel etching
Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive without enamel etching
1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) and dentin (15sec) etching with phosphoric acid 4. Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA) 5. Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec 6. Finishing and polishing
University of Athenss
Athens, Attica, 11527, Greece
Effie Pappa, DDs, MSc, PhD
University of Athens
32 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2020
First Posted
September 28, 2020
Study Start
July 21, 2020
Actual (reported)Non carious cervical lesions which will receive composite-resin restorations, with a two step etch-and-rinse adhesive
1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec 4. Composite-resin application using a transparent cervical matrix and curing for 40sec 5. Finishing and polishing
1. Mechanical removal of sclerotic dentin with a round bur 2. Enamel beveling 3. Enamel (30sec) etching with phosphoric acid 4. Application of AdheSE One and curing for 10sec 5. Composite-resin application using a transparent cervical matrix and curing for 40sec 6. Finishing and polishing
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Primary Completion
October 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 10, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 28, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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