Clinical Performance of Three Universal Adhesives in Posterior Restorations

NCT ID: NCT05696431

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-05

Study Completion Date

2024-11-05

Brief Summary

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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

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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.

Conditions

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Recurrent Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Universal adhesives application

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Fluoride-releasing universal adhesive

Intervention Type OTHER

Fluoride-releasing universal adhesive

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.

Group Type ACTIVE_COMPARATOR

universal adhesive with bioactive properties

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Fluoride-releasing universal adhesive

Fluoride-releasing universal adhesive

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yassmine F El-Sayed, Assis.Lec

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Mansoura University

Locations

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Faculty of dentistry-Mansoura university

Al Mansurah, Dakahia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yassmine F El-Sayed, Assis.Lec

Role: CONTACT

01004855670

Facility Contacts

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Faculty of dentistry Mansoura university

Role: primary

2202835

Other Identifiers

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A01041022

Identifier Type: -

Identifier Source: org_study_id

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