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Clinical Trials/NCT06346795
NCT06346795
Not yet recruiting
Not Applicable

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

Selcuk University1 site in 1 country60 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Selcuk University
Enrollment
60
Locations
1
Primary Endpoint
Retention
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
June 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Gurses

Assistant Proffesor

Selcuk University

Eligibility Criteria

Inclusion Criteria

  • A patient presenting with;
  • over 18 years of age
  • a normal periodontal status and good general health
  • proximal caries that are similar in size to premolar and molar teeth
  • vital teeth
  • teeth in contact with the opposing tooth and subjected to normal occlusal forces
  • attend follow-up appointments

Exclusion Criteria

  • poor oral hygiene status
  • those with severe or chronic periodontitis
  • absence of adjacent and antagonist teeth
  • potential behavioral problems (e.g. bruxism)
  • allergy to any product used in the study
  • exposure of the pulp during cavity preparation
  • systemically unhealthy
  • pregnant and lactating women

Outcomes

Primary Outcomes

Retention

Time Frame: 7th day, 6th month, 12th month.

No loss of restorative material

Color match

Time Frame: 7th day, 6th month, 12th month.

The restoration matches the adjacent tooth structure in color and translucency

Marginal discoloration

Time Frame: 7th day, 6th month, 12th month.

There is no discoloration anywhere on the margin between the restoration and the tooth structure

Surface texture

Time Frame: 7th day, 6th month, 12th month.

The surface of the restoration does not have any defects

Marginal adaptation

Time Frame: 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

Time Frame: 7th day, 6th month, 12th month.

No evidence of secondary caries

Anatomical form

Time Frame: 7th day, 6th month, 12th month.

The restoration is continuous with the existing anatomic form

Postoperative sensitivity

Time Frame: 7th day, 6th month, 12th month.

No postoperative sensitivity, after the restorative procedure and during the study

Study Sites (1)

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