Actively Recruiting

Phase Not Applicable
Age: 35Years - 50Years
All Genders
Healthy Volunteers
ID06772051

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

Led by Mansoura University · Updated on 2025-01-13

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the two-year clinical performance of Class I resin composite dental restorations using a universal adhesive applied with different bonding methods. The study compares three etching strategies: a 15-second etch-and-rinse, a 5-second etch-and-rinse, and a self-etch technique. This randomized, double-blind trial is designed to provide clear evidence on how these methods affect restoration success for adults aged 35 to 50 years. The study includes thirty adult patients who will each receive three restorations, one for each bonding method, following a split-mouth design. The three treatment groups involve applying phosphoric acid etching for either 15 seconds or 5 seconds followed by adhesive application, or applying the universal adhesive directly in self-etch mode. The trial will run from December 2024 to December 2026 with strict protocols approved by an ethics committee to ensure patient safety and study quality. Participants will be monitored over two years with assessments focusing on postoperative tooth sensitivity and the adaptation of the restoration margins. Evaluations include clinical exams and electric pulp testing to check the health of the treated teeth. Patients will provide informed consent and attend regular follow-up visits to track restoration performance and oral health throughout the study period.

CONDITIONS

Brief Title

Clinical Evaluation of Short Dentin Etching

Who Can Participate

Age: 35Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with three primary occlusal caries of upper or lower posterior teeth
  • Patients must have good oral hygiene
  • Patients with teeth that respond positively to electric pulp testing
  • Patients with normal and full occlusion
  • Patients with natural opposing teeth without restorations
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive resin composite restorations bonded using universal adhesive with different dentin etching strategies and durations.

1 visit (in-person)

Follow-up

Duration - Up to 2 years after restoration

Participants are monitored for postoperative hypersensitivity, pulp status, and marginal adaptation of restorations.

Periodic visits during 2 years

Trial Site Locations

Total: 1 location

1

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, Egypt, 35516

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Research Team

H

Hoda S Ismail, Lecturer

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

3

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