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Effect of an Additional Hydrophobic Adhesive Layer Application on the Class V Composite Restorations

NCT05635981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-12-02

No results posted yet for this study

Summary

In restorative dentistry, to enhance bond strength between dentin and simplified adhesive systems, new materials or applications are constantly being developed all the time. In order to create a better hybrid layer quality, modifications are made to the chemical contents and application methods of the adhesives. For inhibition or slow down of collagen or resin matrix degradation at the adhesive interface, procedures like using protease enzyme inhibitors or additional hydrophobic layer applications are tested by in vitro and in vivo studies.

The main goal of this double-blind randomized clinical trial is to evaluate the 18-month clinical performances of two different one-step dentin adhesives that were applied alone or with an additional hydrophobic adhesive layer to non-carious cervical lesions.

The hypotheses are that (1) Additional Hydrophobic Adhesive layer application can provide better clinical performance in class V restorations and, (2) the HEMA content will cause statistically different clinical performances.

Conditions

  • Non Carious Cervical Lesion

Interventions

OTHER

Clearfil Majesty ES-2 Resin Composit Application to Non-carious Cervical Lesions

A restorative treatment method that is applied to non-carious cervical lesions using composite resin restoration after adhesive material application.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Meriç Berkman, pHD · Istanbul University

  • Safa Tuncer, Professor · Istanbul University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2021-03-10
Completion
2021-04-01

Countries

  • Turkey (Türkiye)

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 NCT05635981 on ClinicalTrials.gov