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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05161559
Other study ID # A12151221
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2018
Est. completion date October 30, 2021

Study information

Verified date December 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.


Description:

The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years. The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 30, 2021
Est. primary completion date September 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: 1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3. 2. Patients with normal and full occlusion. 3. Patients with tooth gives positive response to testing with an electric pulp tester. 4. Patients must have a good oral hygiene. 5. Patients with opposing teeth should be natural with no restorations. Exclusion Criteria: 1. High caries risk patients with extremely poor oral hygiene. 2. Patients involved in orthodontic treatment or periodontal surgery. 3. Patients with periodontally involved teeth (chronic periodontitis). 4. Patients with heavy bruxism habits and clenching. 5. Patients with abutments should be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)
Self-etch adhesive (Kuraray, Tokyo, Japan)
No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)
Chemical bond adhesive (GC, Corporation, Tokyo, Japan)
Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage % of patients with marginal staining Percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement. 3 years after restoration procedure
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