Class II Restorations With High-Filled Flowable Composites

Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins

In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p<0.05).

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Class II Dental Caries
• Intervention / Treatment: Other: High-filling flowable dental composite

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MERVE GÜRSES; Phone Number: +905313747997; Email: merve.gurses@selcuk.edu.tr

Study Locations

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

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: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: G-aenial Universal Injectable	Other: High-filling flowable dental composite; Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.
Experimental: Grandio Flow	Other: High-filling flowable dental composite; Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.
Experimental: Clearfil Majesty Flow	Other: High-filling flowable dental composite; Class II restorations will be performed with G-aenial Universal Injectable, Grandio Flow, and Clearfil Majesty Flow high-filling flowable composites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	No loss of restorative material	7th day, 6th month, 12th month.
Color match	The restoration matches the adjacent tooth structure in color and translucency	7th day, 6th month, 12th month.
Marginal discoloration	There is no discoloration anywhere on the margin between the restoration and the tooth structure	7th day, 6th month, 12th month.
Marginal adaptation	There is no visible evidence of a crevice along the margin into which the explorer will penetrate	7th day, 6th month, 12th month.
Secondary caries	No evidence of secondary caries	7th day, 6th month, 12th month.
Surface texture	The surface of the restoration does not have any defects	7th day, 6th month, 12th month.
Anatomical form	The restoration is continuous with the existing anatomic form	7th day, 6th month, 12th month.
Postoperative sensitivity	No postoperative sensitivity, after the restorative procedure and during the study	7th day, 6th month, 12th month.

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Merve Gürses, Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

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): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 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: SelcukC

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