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

NCT04565938 | Unknown Phase 2

• 1 other identifier: 118/12-3-2009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

One-step Adhesive; Self-etch Adhesive; Non-carious cervical lesions; Clinical trial

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

one-step self-etch adhesive with enamel etching

EXPERIMENTAL

Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive with enamel etching

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

one-step self-etch adhesive without enamel etching

EXPERIMENTAL

Non carious cervical lesions which will receive composite-resin restorations, with one-step self-etch adhesive without enamel etching

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

two-step etch-and-rinse adhesive

EXPERIMENTAL

Non carious cervical lesions which will receive composite-resin restorations, with a two step etch-and-rinse adhesive

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

Interventions

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

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

two-step etch-and-rinse adhesive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth

You may not qualify if:

• Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

University of Athenss

Athens, Attica, 11527, Greece

Location

MeSH Terms

Interventions

Composite Resins

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Effie Pappa, DDs, MSc, PhD

  University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: July 21, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 10, 2020
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)