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NCT Number: NCT06772051

Clinical Evaluation of Short Dentin Etching

To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.

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Key information

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, 35516, Egypt

Location status: Recruiting

Location contact

Hoda S Ismail, Lecturer

CONTACT

About this study

The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a split mouth design. A total of thirty adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on ninety Class I restorations. No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from December 2024 to December 2026. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation. To determine the appropriate sample size, previous studies examining the clinical success rate of posterior Class I restorations restored using different adhesive strategies were considered. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 30 subjects (Three restorations per patient) was determined to be suitable.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with three primary occlusal caries of upper or lower posterior teeth.
  • Patients must have a good oral hygiene;
  • Patients with tooth gives a positive response to testing with an electric pulp tester
  • Patients with normal and full occlusion,
  • Patients with opposing teeth should be natural with no restorations.

Exclusion criteria

  • High caries risk patients with extremely poor oral hygiene
  • Patients involved in orthodontic treatment or periodontal surgery,
  • Patients with periodontally involved teeth (chronic

Treatment and study plan

Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)

Procedure

Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)

Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)

Procedure

Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)

Resin composite restoration bonded using universal adhesive in self-etch mode

Procedure

Resin composite restoration bonded using universal adhesive in self-etch mode

Primary outcomes

  1. Postoperative hypersensitivity/pulp status

    Time frame: Two years after restoration

    The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.

  2. Marginal adaptation

    Time frame: Two years after restoration

    The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.

Study contacts

Contact information is provided by the study sponsor or research team.

Hoda S Ismail, Lecturer

CONTACT

[email protected]

01005395069

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Short Dentin Etching With a Universal Adhesive: Two-Year Double-Blind Trial Comparing Etching Strategies and Durations

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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