Guided Bone Regeneration Versus Bone Block Grafting

Not Applicable

Completed

• Conditions: Atrophy; Bone
• Interventions: Procedure: Guided bone regeneration; Procedure: Khoury technique

• Registration Number: NCT05593198
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-05
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Study Start: 2022-11-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-02
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided bone regeneration	Guided bone regeneration	Patients will be treated with guided bone regeneration.
Bone block	Khoury technique	Patients will be treated with bone blocks using the Khoury technique.

Primary Outcome Measures

Name	Time	Method
Bone volume	6 Months follow up	the bone volume will be analyzed with the Cone Beam Computed Tomography scan

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy