Histological Analysis of Peri-implant Soft Tissue | NCT06862505

Studies
Histological Analysis of Peri-implant Soft Tissue

NCT06862505

Sponsor

Università degli Studi di Sassari

Status

Completed

Last Update Posted

Mar 6, 2025Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Implant Therapy
Biological Width

Interventions

Biopsy

Countries

Italy

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

Mar 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

Feb 15, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Feb 3, 2025Actual

First Submitted Date

Feb 25, 2025

First Submission Date that Met QC Criteria

Mar 3, 2025

First Posted Date

Mar 6, 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

Mar 3, 2025

Last Update Posted Date

Mar 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco Tallarico, Associate Professor, Università degli Studi di SassariPrincipal Investigator

Lead Sponsor

Università degli Studi di SassariOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biopsy at 8 weeks	Experimental		Procedure: Biopsy
Biopsy at 16 weeks	Active Comparator		Procedure: Biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biopsy	Procedure	Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue	Biopsy at 16 weeks Biopsy at 8 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histological analisys	Histological analysis of peri-implant gengivaat 8 and 16 weeks to assess collagen fibre orientation	8 and 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Histomorphometry	Quantitative measure of soft tissues	8 and 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
able to understand a sign an informed consent

Exclusion Criteria:

Peapole having a systemic or local contraindications for implant placement;
Untreated periodontal disease;
smokers;
osteoporosis;
uncontrolled diabetes;
refusal to implant rehabilitation;
refusal to biopsy collection;
systemic pathologies that could compromise the healing of peri-implant tissues.

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Rome		Rome	Italy		Italy

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

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided