Clinical Evaluation of Three Different Universal Adhesives in Non-carious Cervical Lesions

Tooth Diseases Clinical Trial

Official title:

Clinical Evaluation of Three Different Universal Adhesives and a Universal Flowable Composite for Restoration of Non-carious Cervical Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03415412
• Other study ID #: NCCLsclinic
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized, controlled prospective clinical trial is to evaluate and compare the performances of three different universal adhesives using a flowable universal composite resin in the restoration of non-caries cervical lesions over 48-month period.Participants over 18 will be included to the study. Oral hygiene instructions will be given before procedures. All the lesions will be restored by the same clinician who will not participate to the selection of patients for eligibility. Each patient will receive at least three restorations and randomization will be applied using a table of random numbers. All lesions will be cleaned before restoring. Adhesive procedures and restorations will be placed according to manufacturers' recommandation.

The flowable universal composite resin will be placed in bulk and light-cured for 40 seconds. The restorations will be contoured and polished with Optidisc discs (Kerr Coorporation, Orange, CA, USA).

Patients will be recalled at baseline and will be recalled at control periods after placement.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 years old with 20 teeth under occlusion. They will be required to have at least three NCCLs needed restoration in different teeth. All the NCCLs selected were in similar sizes varying between 1-3 mm.

Exclusion Criteria:

• Patients with severe periodontal disease, rampant, uncontrolled caries, xerostomia, serious medical problems preventing them from attending review visits, poor gingival health, heavy bruxism and removable partial dentures will not be included in the present study. Also, participiants will be excluded, if they are undergoing bleaching treatment or orthodontic treatment.

Related Conditions & MeSH terms

• Tooth Diseases

Intervention

Device:
• Clearfil Univesal Bond
Adhesive systems
• IBond Universal
Adhesive systems
• G-Premio Bond
Adhesive systems

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performances of different universal adhesives	Two year results according to USPHS criteria	Two years