Clinical Performance of Three Universal Adhesives in Posterior Restorations

January 23, 2023 updated by: Mansoura University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahia
      • Mansoura, Dakahia, Egypt, 35516
        • Recruiting
        • Faculty of Dentistry-Mansoura University
        • Contact:
          • Faculty of dentistry Mansoura university
          • Phone Number: 2202835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Universal adhesive
After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a universal adhesive as control group.
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.
Active Comparator: Fluoride-releasing universal adhesive
After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used. This group will receive a Fluoride-releasing universal adhesive.
Other: Fluoride-releasing universal adhesive
Fluoride-releasing universal adhesive
Active Comparator: Universal adhesive with bioactive properties
After preparation of three posterior cavities in each patient. The cavities will be randomly divided into three groups according to the type of the adhesive used.This group will receive a universal adhesive with bioactive properties.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic, functional and biological properties for composite restorations
Time Frame: 2 years after restorations application

Composite restorations will be clinically assessed based on International dental federation (FDI) criteria.

Scores from 1 to 5,

  1. Clinically excellent
  2. Clinically good
  3. Clinically sufficient
  4. Clinically unsatisfactory
  5. Clinically poor
2 years after restorations application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic examination
Time Frame: 2 years after restorations application
Restorative materials will be examined radiographically every 6 months.
2 years after restorations application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Yassmine F El-Sayed, Assis.Lec, Faculty of Dentistry, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2022

Primary Completion (Anticipated)

November 5, 2024

Study Completion (Anticipated)

November 5, 2024

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A01041022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Data will be available within 6 Months for 2 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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