Comparative Evaluation of Class V Restorations

NCT06164418 | Active Not Recruiting

• 1 other identifier: A01011023 CD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding

Conditions

Secondary Caries; Dental Restoration Failure of Marginal Integrity

Outcome Measures

Primary Outcomes (1)

• Percentage of aesthetic, functional and biological properties for each group

  Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group

  2 years after restoration

Study Arms (4)

a nanohybrid resin composite material with a universal adhesive

PLACEBO COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Procedure: Dental restoration

a nanohybrid resin composite material with a fluoride-releasing universal adhesive

ACTIVE COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Procedure: Dental restoration

ion-releasing restorative material with a universal adhesive

PLACEBO COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Procedure: Dental restoration

ion-releasing restorative material with a fluoride-releasing universal adhesive

ACTIVE COMPARATOR

Each patient will randomly receive one cervical restoration with one of the tested restorative systems

Procedure: Dental restoration

Interventions

Dental restoration PROCEDURE

Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material

a nanohybrid resin composite material with a fluoride-releasing universal adhesive; a nanohybrid resin composite material with a universal adhesive; ion-releasing restorative material with a fluoride-releasing universal adhesive; ion-releasing restorative material with a universal adhesive

Eligibility Criteria

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

You may qualify if:

• Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin
• 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 periodontitis)
• Patients with heavy bruxism habits and clenching

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Hoda Saleh Ismail

Al Mansurah, Dakahliya, 35516, Egypt

Location

Study Officials

• Hoda S Ismail, Lecturer

  Faculty of Dentistry, Mansoura University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant and Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Each patient will receive one restoration in a posterior tooth on any side randomly selected from the 4 tested restorative systems groups, all materials will be used according to manufacturers' instructions

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: December 2, 2023
• Primary Completion: December 2, 2025
• Study Completion: December 15, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 6 Months for 2 years
• Access Criteria: for anyone

Locations

EG (1)