Clinical Evaluation of Class II Restorations

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

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).

Study Overview

• Status: Completed
• Conditions: Dental Caries; Dental Caries Class II
• Intervention / Treatment: Other: Treatment of dental caries.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Selcuk University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G-aenial A'CHORD universal composite	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.
Experimental: Tetric Prime universal composite	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.
Experimental: Filtek Ultimate universal composite	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.
Experimental: G-aenial Universal Injectable composite	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	No loss of restorative material	seventh day, sixth month, twelfth month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
color match	The restoration matches the adjacent tooth structure in color and translucency	seventh day, sixth month, twelfth month
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
marginal discoloration	There is no discoloration anywhere on the margin between the restoration and the tooth structure	seventh day, sixth month, twelfth month
surface texture	The surface of the restoration does not have any defects	seventh day, sixth month, twelfth month
anatomical form	The restoration is continuous with the existing anatomic form	seventh day, sixth month, twelfth month
secondary caries	No evidence of secondary caries	seventh day, sixth month, twelfth month
postoperative sensitivity	No postoperative sensitivity, after the restorative procedure and during the study	seventh day, sixth month, twelfth month

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: MERVE GÜRSES, Selcuk University, Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: SelcukA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No