Guided Bone Regeneration Versus Bone Block Grafting

NCT ID: NCT05593198

Last Updated: 2023-08-29

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

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-07-02

Brief Summary

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The purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.

Detailed Description

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Conditions

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Atrophy; Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Guided bone regeneration

Patients will be treated with guided bone regeneration.

Group Type ACTIVE_COMPARATOR

Guided bone regeneration

Intervention Type PROCEDURE

the membrane and the bone granules will be used to perform the guided bone regeneration technique.

Bone block

Patients will be treated with bone blocks using the Khoury technique.

Group Type EXPERIMENTAL

Khoury technique

Intervention Type PROCEDURE

the bone block will be used following the principles of the Khoury technique to augment the bone volume.

Interventions

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Khoury technique

the bone block will be used following the principles of the Khoury technique to augment the bone volume.

Intervention Type PROCEDURE

Guided bone regeneration

the membrane and the bone granules will be used to perform the guided bone regeneration technique.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients in need of an implant-supported rehabilitation
* Patients requiring bone regeneration
* Healthy patients
* Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 15%
* Sufficient mesiodistal and interocclusal space
* At least 6 months of follow-up

Exclusion Criteria

* An American Society of Anesthesiologists physical status classification ≥ III
* General contraindications for surgical treatment or implant placement
* Untreated periodontitis
* Smoking
* Excessive alcohol consumption
* Any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment
* No residual keratinized tissue at the experimental area
* Unwillingness to return for follow-up examinations
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio D'Addona, DDS

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli

Locations

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Fondazione Policlinico Gemelli

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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4729

Identifier Type: -

Identifier Source: org_study_id

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