Evaluation of the Clinical Performance of Different Compo... | NCT07343063

Studies
Evaluation of the Clinical Performance of Different Composite Materials in Class III and IV Restorations.

NCT07343063

Sponsor

Recep Tayyip Erdogan University

Status

Recruiting

Last Update Posted

Jan 15, 2026Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Dentin Caries

Interventions

Composite materials

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 16, 2025Actual

Primary Completion Date

Jan 16, 2027Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2026

Last Update Posted Date

Jan 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammet Karadaş, Clinical Professor, Recep Tayyip Erdogan UniversityPrincipal Investigator

Lead Sponsor

Recep Tayyip Erdogan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, a universal adhesive was used with different adhesive techniques (self-etch and total-etch modes) and evaluated for 18 months in three different types of composite material class III and class IV restorations according to the FDI criteria. The hypotheses tested in this study are: (1) clinical success will not differ between different composite materials and (2) clinical outcomes will not differ between different application modes of the universal adhesive.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Composite materials	Other	Restorations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FDI criteria	very good, good, poor, very poor	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good general health
No heart disease,
No diabetes
No systemic diseases such as hypertension

Exclusion Criteria:

Individuals with advanced periodontitis and associated postoperative sensitivity
Pregnant and breastfeeding women
Individuals undergoing orthodontic treatment and using appliances
Individuals with direct pulp capping
Individuals with bruxism

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All restorations to be evaluated in this study were performed at the Department of Restorative Dentistry, Faculty of Dentistry, Recep Tayyip Erdoğan University. Participants who received routine dental treatment at the university's dental clinic and whose records were kept will be included in the research.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muhammet Karadaş	Recruiting	Merkez	Rize Province	53100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided