Clinical trial NCT05696431: Clinical Performance of Three Universal Adhesives in Posterior Restorations
Official title: Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Caries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will receive the three universal adhesives with the same restorative material randomly in three posterior teeth. All the materials will be used according to their manufacturers' instructions.
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate and compare the two-year clinical performance of three universal adhesives in posterior composite restorations, based on International dental federation (FDI) criteria.

Detailed description: The description of the experimental design will follow the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study will be a double blinded (patients and examiner) randomized clinical trial anticipating the split-mouth design. 30 adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, Mansoura University will be enrolled in the current study with a total of 90 teeth with Class I or II posterior composite restorations.

No advertisement will be made for participant recruitment, forming a sample of convenience. Each patient will sign a consent form before participating in the current study. The study will be conducted from November 2022 to November 2024 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on a previous study with a similar study design. Parameters including a significance level of 5% (p \< 0.05) and a power of 80% were used to calculate an appropriate sample size of 28 cases. Allowing for a 20% drop-out rate, the total sample size was set at 30 cases.

Eligibility criteria: Inclusion Criteria:

* Patients will have at least 3 posterior teeth with carious lesions of ICDAS score 4, or 5.
* The teeth will have to be vital, without spontaneous pain and/or mobility.
* Patients must have a good oral hygiene.
* Patients with normal and full occlusion.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene.
* Patients with abutments.
* Patients with heavy bruxism habits and clenching.

Primary outcomes:
measure: Aesthetic, functional and biological properties for composite restorations
timeFrame: 2 years after restorations application
Secondary outcomes:
measure: Radiographic examination
timeFrame: 2 years after restorations application
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry-Mansoura university
state: Dakahia
Study officials:
affiliation: Faculty of Dentistry, Mansoura University
name: Yassmine F El-Sayed, Assis.Lec
role: PRINCIPAL_INVESTIGATOR
References: