Histological Analysis of Peri-implant Soft Tissue

NCT ID: NCT06862505

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-02-03

Brief Summary

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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

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Conditions

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Implant Therapy Biological Width

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biopsy at 8 weeks

Group Type EXPERIMENTAL

Biopsy

Intervention Type PROCEDURE

Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue

Biopsy at 16 weeks

Group Type ACTIVE_COMPARATOR

Biopsy

Intervention Type PROCEDURE

Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue

Interventions

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Biopsy

Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Marco Tallarico

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rome

Rome, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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15-16/12/24

Identifier Type: -

Identifier Source: org_study_id

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