Clinical Evaluation of Short Dentin Etching

NCT06772051 | Recruiting

• 1 other identifier: A04012024 CD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypersensitivity Dentin; Dental Restoration Failure of Marginal Integrity

Outcome Measures

Primary Outcomes (2)

• Postoperative hypersensitivity/pulp status

  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.

  Two years after restoration

• Marginal adaptation

  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.

  Two years after restoration

Study Arms (3)

Dentin etching and rinse (15 seconds etching)

PLACEBO COMPARATOR

The dentin in the pulpal floor in this group will receive phosphoric acid etching for 15 seconds followed by rinsing and drying before universal adhesive application

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

Dentin etching and rinse (5 seconds etching)

ACTIVE COMPARATOR

The dentin in the pulpal floor in this group will receive phosphoric acid etching for 5 seconds followed by rinsing and drying before universal adhesive application

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

Dentin self-etch

PLACEBO COMPARATOR

The dentin in the pulpal floor in this group will receive universal adhesive application in self-etch mode without prior phosphoric acid etching

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

Interventions

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)

Dentin etching and rinse (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)

Dentin etching and rinse (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

Dentin self-etch

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hoda S Ismail, Lecturer

  Faculty of Dentistry, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoda S Ismail, Lecturer

CONTACT

01005395069; hoda_saleh@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will receive three restorations in posterior teeth randomly on three different quadrants, each tooth will be restored with one of the three tested adhesive strategies. All materials will be used according to manufacturers' instructions

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 13, 2025
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

EG (1)