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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06346795
Other study ID # SelcukC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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