Clinical Evaluation of Class II Restorations

Not Applicable

Completed

• Conditions: Dental Caries; Dental Caries Class II
• Interventions: Other: Treatment of dental caries.

• Registration Number: NCT06346756
• Lead Sponsor: Selcuk University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-15
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-aenial A'CHORD universal composite	Treatment of dental caries.	-
Tetric Prime universal composite	Treatment of dental caries.	-
G-aenial Universal Injectable composite	Treatment of dental caries.	-
Filtek Ultimate universal composite	Treatment of dental caries.	-

Primary Outcome Measures

Name	Time	Method
Retention	seventh day, sixth month, twelfth month	No loss of restorative material

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Selcuk University, Faculty of Dentistry; 🇹🇷 Konya, Turkey