The Effect of Ground and Unground Enamel on the Clinical... | NCT05590806

Studies
The Effect of Ground and Unground Enamel on the Clinical Performance of Direct Composite Build-ups

NCT05590806

Sponsor

Istanbul University

Status

Unknown status

Last Update Posted

Sep 28, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Trial of Labor; Failure

Interventions

Direct composite build-ups

Countries

Not provided

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2011Actual

Primary Completion Date

Oct 30, 2015Actual

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 20, 2022

First Posted Date

Oct 21, 2022Actual

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

Sep 27, 2023

Last Update Posted Date

Sep 28, 2023Actual

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

Twenty-four patients participated in the study. Patients received direct composite build-ups for diastema closure.

Detailed Description

The restorations were performed separately by grounding and ungrounding the enamel on the proximal surfaces in symmetrical teeth.

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Restoration	Other: Direct composite build-ups
Arm 2	Experimental	Evaluate	Other: Direct composite build-ups

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct composite build-ups	Other	Direct composite build-ups application	Arm 1 Arm 2

Measure	Description	Time Frame
Success rate		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good oral hygiene, no periodontal or pulpal disease, interarch tooth size discrepancies (Bolton discrepancy) after orthodontic treatment

Exclusion Criteria:

uncontrollable parafunctions, insufficient or poor oral hygiene, periodontal or gingival disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

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