Back to resultsGuided Bone Regeneration Versus Bone Block Grafting
Primary Purpose
Atrophy; Bone
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Khoury technique
Guided bone regeneration
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy; Bone focused on measuring Bone Regeneration
Eligibility Criteria
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
Sites / Locations
- Fondazione Policlinico Gemelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Guided bone regeneration
Bone block
Arm Description
Patients will be treated with guided bone regeneration.
Patients will be treated with bone blocks using the Khoury technique.
Outcomes
Primary Outcome Measures
Bone volume
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05593198
First Posted
September 5, 2022
Last Updated
August 28, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05593198
Brief Title
Guided Bone Regeneration Versus Bone Block Grafting
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy; Bone
Keywords
Bone Regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided bone regeneration
Arm Type
Active Comparator
Arm Description
Patients will be treated with guided bone regeneration.
Arm Title
Bone block
Arm Type
Experimental
Arm Description
Patients will be treated with bone blocks using the Khoury technique.
Intervention Type
Procedure
Intervention Name(s)
Khoury technique
Intervention Description
the bone block will be used following the principles of the Khoury technique to augment the bone volume.
Intervention Type
Procedure
Intervention Name(s)
Guided bone regeneration
Intervention Description
the membrane and the bone granules will be used to perform the guided bone regeneration technique.
Primary Outcome Measure Information:
Title
Bone volume
Description
the bone volume will be analyzed with the Cone Beam Computed Tomography scan
Time Frame
6 Months follow up
Secondary Outcome Measure Information:
Title
Periodontal parameters
Description
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.
Time Frame
6 Months follow up
Title
Wound healing
Description
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.
Time Frame
2 weeks follow up
Title
Histological analysis
Description
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.
Time Frame
6 Months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio D'Addona, DDS
Organizational Affiliation
Fondazione Policlinico Gemelli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Gemelli
City
Rome
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Guided Bone Regeneration Versus Bone Block Grafting
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