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Clinical Performance of a One-step Self-etch Adhesive in Non-carious Cervical Lesions at 2 Years

NCT04565938 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-09-28

No results posted yet for this study

Summary

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).

Conditions

  • Non-carious Cervical Lesions
  • Adhesive Performance

Interventions

PROCEDURE

Application of adhesive for the restoration of dental lesions with resin composite

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

PROCEDURE

Application of adhesive for the restoration of dental lesions with resin composite

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

PROCEDURE

Application of adhesive for the restoration of dental lesions with resin composite

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

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Effie Pappa, DDs, MSc, PhD · University of Athens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2020-10-01
Completion
2020-10-10

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04565938 on ClinicalTrials.gov