Class II Restorations With High-Filled Flowable Composites

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346795
• Other study ID #: SelcukC
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Selcuk University
• Contact: MERVE GÜRSES
• Phone: +905313747997
• Email: merve.gurses[@]selcuk.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• 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

• Class II Dental Caries
• Dental Caries

Intervention

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.

Locations

Country	Name	City	State
Turkey	Selcuk University, Faculty of Dentistry, Restorative Dentistry Department	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	7th day, 6th month, 12th month.
Primary	Color match	The restoration matches the adjacent tooth structure in color and translucency	7th day, 6th month, 12th month.
Primary	Marginal discoloration	There is no discoloration anywhere on the margin between the restoration and the tooth structure	7th day, 6th month, 12th month.
Primary	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.
Primary	Secondary caries	No evidence of secondary caries	7th day, 6th month, 12th month.
Primary	Surface texture	The surface of the restoration does not have any defects	7th day, 6th month, 12th month.
Primary	Anatomical form	The restoration is continuous with the existing anatomic form	7th day, 6th month, 12th month.
Primary	Postoperative sensitivity	No postoperative sensitivity, after the restorative procedure and during the study	7th day, 6th month, 12th month.