Clinical Performance of Three Universal Adhesives in Posterior Restorations

Recurrent Caries Clinical Trial

Official title:

Comparative Evaluation of Two-Year Clinical Performance of Three Universal Adhesives in Posterior Restorations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696431
• Other study ID #: A01041022
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2022
• Est. completion date: November 5, 2024

Study information

• Verified date: November 2022
• Source: Mansoura University
• Contact: Yassmine F El-Sayed, Assis.Lec
• Phone: 01004855670
• Email: yassmine[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 5, 2024
• Est. primary completion date: November 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Caries

Intervention

Other:
• Universal adhesives application
The adhesive will be used according to their manufacturer's instructions. Selective etching for enamel will be applied for 15 seconds, followed by rinsing and gentle air drying. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
• universal adhesive with bioactive properties
The adhesive will be used according to their manufacturer's instructions. Enamel and dentin will be cleaned using clean and boost for 10 seconds, rinsed and gently dried. Then, the adhesive will be applied to enamel and dentin and light cured using a light-curing unit for 20 seconds. The composite material will be incrementally applied, and each increment will be light cured for 20 seconds. The restoration will be finished and polished using finishing and polishing instruments.
• Fluoride-releasing universal adhesive
Fluoride-releasing universal adhesive

Locations

Country	Name	City	State
Egypt	Faculty of dentistry-Mansoura university	Mansoura	Dakahia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aesthetic, functional and biological properties for composite restorations	Composite restorations will be clinically assessed based on International dental federation (FDI) criteria.; Scores from 1 to 5,; Clinically excellent; Clinically good; Clinically sufficient; Clinically unsatisfactory; Clinically poor	2 years after restorations application
Secondary	Radiographic examination	Restorative materials will be examined radiographically every 6 months.	2 years after restorations application