Clinical Evaluation of Class II Restorations

Dental Caries Clinical Trial

Official title:

Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06346756
• Other study ID #: SelcukA
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

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