Clinical Trial for Printed Implant Resin Crowns | NCT07113509

Studies
Clinical Trial for Printed Implant Resin Crowns

NCT07113509

Sponsor

Ege University

Status

Completed

Last Update Posted

Aug 8, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Surface Finish
Wear

Interventions

mechanical polishing
glazing

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

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

May 15, 2024Actual

Completion Date

May 31, 2024Actual

First Submitted Date

Jul 25, 2025

First Submission Date that Met QC Criteria

Aug 2, 2025

First Posted Date

Aug 8, 2025Actual

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

Aug 2, 2025

Last Update Posted Date

Aug 8, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to assess the clinical performance of printed resinous implant crowns with two surface finishing protocols-mechanical polishing versus glazing. Qualitative performance will be checked by scoring systems.

The main questions it aims to answer are;

Do printed resin implant crowns clinically succeed in the sort-term?
Do mechanical polishing or glazing the crowns would be better for clinical performance?

Participants will:

receive either mechanically polished or glazed printed resin implant crowns,
visit at 6-months and 1 year for clinical check

Detailed Description

Wear amounts of the printed resin implant crowns will be measured

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mechanical polishing	Active Comparator	surface finishing with mechanical polishing	Procedure: mechanical polishing
glazing	Active Comparator	glaze liquid application and curing	Procedure: glazing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mechanical polishing	Procedure	mechanical polishing of implant resin crowns with polishing paste and discs	mechanical polishing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
printed resin implant crown survival	survival with repairable failures	From enrollment to the end of treatment at 6 months
no catastrophic failure of the printed resin implant crowns	clinical performance with repairable failures	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

single-tooth edentulism
no head/neck radiotherapy or bisphosphonate/denosumab therapy
adequate alveolar crest width (implant diameter + 3 mm)
absence of active periodontal disease, and willingness to comply.

Exclusion Criteria:

ASA class III
heavy smoking (>20 cigarettes/day)
pregnancy or lactation
allergies to titanium
need for hard or soft tissue augmentation
bisphosphonate/denosumab therapy
head/neck radiotherapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ercan Yigit, PhD	Ege University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ege University Faculty of Dentistry		Izmir		35100	Turkey (Türkiye)

Label	URL
rationale and reference for the study set up	View source

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