Class II Restorations With High-Filled Flowable Composites

Not Applicable

Not yet recruiting

• Conditions: Dental Caries; Class II Dental Caries
• Interventions: Other: High-filling flowable dental composite

• Registration Number: NCT06346795
• Lead Sponsor: Selcuk University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Status Verified: 2024-04
• Study First Posted: 2024-04-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Study Start: 2024-06-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 Universal Injectable	High-filling flowable dental composite	-
Clearfil Majesty Flow	High-filling flowable dental composite	-
Grandio Flow	High-filling flowable dental composite	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

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