Clinical trial NCT06164418: Comparative Evaluation of Class V Restorations
Official title: Comparative Evaluation of Class V Restorations: 2-Year Randomized Double-Blind Trial Comparing Ion-Releasing Materials and Resin Composite
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Secondary Caries
Dental Restoration Failure of Marginal Integrity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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

Detailed description: 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 parallel design. A total of one hundred 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 one hundred Class V 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 November 2023 to November 2025. 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 V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. 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 100 subjects was determined to be suitable.

Eligibility criteria: Inclusion Criteria:

* 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.

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 periodontitis)
* Patients with heavy bruxism habits and clenching

Primary outcomes:
measure: Percentage of aesthetic, functional and biological properties for each group
timeFrame: 2 years after restoration
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Hoda Saleh Ismail
state: Dakahliya
Study officials:
affiliation: Faculty of Dentistry, Mansoura University, Egypt
name: Hoda S Ismail, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: