Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

Tooth Wear Clinical Trial

Official title:

Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415516
• Other study ID #: Universal Clinical NCCLs
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: November 1, 2018

Study information

• Verified date: September 2021
• 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 the performances of two different universal adhesives and an etch&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch&rinse, SB (Control): Single Bond2+etch&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Inclusion criteria will be as follows:

1. being 18 years or older,

2. having no medical or behavioral problems preventing then from attending review visits,

3. having at least 7 tooth with NCCLs (d) having antagonist teeth.

Exclusion Criteria:

Exlusion criteria will be:

1. poor gingival health,

2. uncontrolled, rampant caries,

3. bruxism,

4. removable partial dentures,

5. xerostomia.

Related Conditions & MeSH terms

• Tooth Wear

Intervention

Device:
• Gluma Universal
Adhesive systems
• All Bond Universal
Adhesive systems

Drug:
• Single Bond2
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 adhesives	Two year examinations according to USPHS criteria	Two years