Guided Bone Regeneration Versus Bone Block Grafting

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05593198

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophy; Bone	Procedure: Khoury technique Procedure: Guided bone regeneration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Clinical Trial Comparing the Clinical Measures and the Radiographical Volumetric Outcomes Assessed by Cone Beam Computed Tomography of Guided Bone Regeneration Versus Bone Block Grafting

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Guided bone regeneration Patients will be treated with guided bone regeneration.	Procedure: Guided bone regeneration the membrane and the bone granules will be used to perform the guided bone regeneration technique.
Experimental: Bone block Patients will be treated with bone blocks using the Khoury technique.	Procedure: Khoury technique the bone block will be used following the principles of the Khoury technique to augment the bone volume.

Arm

Intervention/Treatment

Active Comparator: Guided bone regeneration

Patients will be treated with guided bone regeneration.

Procedure: Guided bone regeneration

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

Experimental: Bone block

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

Procedure: Khoury technique

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

Outcome Measures

Primary Outcome Measures

Bone volume [6 Months follow up]
the bone volume will be analyzed with the Cone Beam Computed Tomography scan

Secondary Outcome Measures

Periodontal parameters [6 Months follow up]
the periodontal parameters will be analyzed clinically with the periodontal probe and measured in millimeters. All the periodontal parameters will be combined to describe the periodontal status of the patient.
Wound healing [2 weeks follow up]
the wound healing will be recorded with the Early Wound Healing Score (EHS) ranging from 0 to 10 which includes the following parameters: clinical signs of re-epithelialization: 0 points, visible distance between incision margins; 3 points, incision margins in contact; 6 points, merged incision margins. clinical signs of haemostasis: 0 points, bleeding at the incision margins; 1 point, presence of fibrin at the incision margins; 2 points, absence of fibrin on the incision margins. clinical signs of inflammation: 0 points, redness involving >50% of the incision length and/or pronounced swelling; 1 point, redness involving <50% of the incision length; 2 points, absence of redness along the incision length.
Histological analysis [6 Months follow up]
The histological analysis will be performed harvesting a sample during the implant placement. Bone biopsies including both native and regenerated bone will be subjected to digital scanning to analyze the characteristics of newly formed bone, the remaining grafted material, integration of grafted material with newly formed bone, soft tissue, and local inflammation. Histomorphometric analyses will be performed to measure the following parameters: bone tissue area , graft material area , soft tissue area. Bone tissue area , graft material area , soft tissue area will be expressed relative to the total area.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Antonio D'Addona, DDS, Fondazione Policlinico Gemelli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05593198

Other Study ID Numbers:

0016547/22

First Posted:

Oct 25, 2022

Last Update Posted:

Oct 25, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Bone Regeneration

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Oct 25, 2022