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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06346756
Other study ID # SelcukA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date July 15, 2023

Study information

Verified date June 2024
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins. The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p<0.05).


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date July 15, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: A patient presenting with; 1. over 18 years of age 2. a normal periodontal status and good general health 3. proximal caries that are similar in size to premolar and molar teeth 4. vital teeth 5. teeth in contact with the opposing tooth and subjected to normal occlusal forces 6. attend follow-up appointments Exclusion Criteria: 1. poor oral hygiene status 2. those with severe or chronic periodontitis 3. absence of adjacent and antagonist teeth 4. potential behavioral problems (e.g. bruxism) 5. allergy to any product used in the study 6. exposure of the pulp during cavity preparation 7. systemically unhealthy 8. pregnant and lactating women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Treatment of dental caries.
The researchers used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), and Filtek Ultimate (FU) composites for premolar Class II restorations.

Locations

Country Name City State
Turkey Selcuk University, Faculty of Dentistry Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention No loss of restorative material seventh day, sixth month, twelfth month
Secondary color match The restoration matches the adjacent tooth structure in color and translucency seventh day, sixth month, twelfth month
Secondary marginal adaptation There is no visible evidence of a crevice along the margin into which the explorer will penetrate seventh day, sixth month, twelfth month
Secondary marginal discoloration There is no discoloration anywhere on the margin between the restoration and the tooth structure seventh day, sixth month, twelfth month
Secondary surface texture The surface of the restoration does not have any defects seventh day, sixth month, twelfth month
Secondary anatomical form The restoration is continuous with the existing anatomic form seventh day, sixth month, twelfth month
Secondary secondary caries No evidence of secondary caries seventh day, sixth month, twelfth month
Secondary postoperative sensitivity No postoperative sensitivity, after the restorative procedure and during the study seventh day, sixth month, twelfth month
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