Guided Bone Regeneration Versus Bone Block Grafting

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

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.

Study Overview

• Status: Completed
• Conditions: Atrophy; Bone
• Intervention / Treatment: Procedure: Guided bone regeneration; Procedure: Khoury technique

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Fondazione Policlinico Gemelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone volume	the bone volume will be analyzed with the Cone Beam Computed Tomography scan	6 Months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal parameters	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.	6 Months follow up
Wound healing	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.	2 weeks follow up
Histological analysis	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.	6 Months follow up

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Antonio D'Addona, DDS, Fondazione Policlinico Gemelli

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 2, 2023

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Bone Regeneration
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 4729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No