Dental Caries Clinical Trial
Official title:
Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites
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 |
Verified date | June 2024 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University, Faculty of Dentistry | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
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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