Back to resultsCortical Bone Plate Versus Cortico-cancellous Block Graft
Primary Purpose
Horizontal Atrophy of Edentulous Alveolar Ridge
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Split-block technique
Cortico-cancellous block graft
Sponsored by
About this trial
This is an interventional treatment trial for Horizontal Atrophy of Edentulous Alveolar Ridge focused on measuring Split-bone block technique, Cortical bone plate, Cortico-cancellous block graft
Eligibility Criteria
Inclusion Criteria:
- Eligible patients aged 18 years or older with partial edentulism of the mandible
- The residual ridge width must be 4 mm or less
- Intra-oral donor sites should be available in the external oblique ridge and symphyseal area
Exclusion Criteria:
- Patients with general contraindications for implant surgery such as uncontrolled diabetes
- Irradiation of the head and neck region
- Intravenous bisphosphonate
- Pregnancy
- Smokers, alcoholics and drug abusers
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cortical bone plate
Cortico-cancellous block graft
Arm Description
A cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge.
A cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge.
Outcomes
Primary Outcome Measures
Evaluation of bone quality
Histomorphometric analysis (Masson's Trichrome stain)
Secondary Outcome Measures
Horizontal ridge dimensional changes
Measuring the linear horizontal changes using CBCT
Full Information
NCT ID
NCT04567966
First Posted
September 24, 2020
Last Updated
September 24, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04567966
Brief Title
Cortical Bone Plate Versus Cortico-cancellous Block Graft
Official Title
Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
January 6, 2020 (Actual)
Study Completion Date
March 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horizontal Atrophy of Edentulous Alveolar Ridge
Keywords
Split-bone block technique, Cortical bone plate, Cortico-cancellous block graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cortical bone plate
Arm Type
Experimental
Arm Description
A cortical plate was harvested from the external oblique ridge and split in half. Then one plate was fixed at a distance from the atrophied ridge and autogenous bone chips were used to fill the gap between the plate and the ridge.
Arm Title
Cortico-cancellous block graft
Arm Type
Active Comparator
Arm Description
A cortico-cancellous block graft was harvested from the symphysis of the mandible and fixed to the atrophied ridge.
Intervention Type
Procedure
Intervention Name(s)
Split-block technique
Intervention Description
Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.
Intervention Type
Procedure
Intervention Name(s)
Cortico-cancellous block graft
Intervention Description
Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.
Primary Outcome Measure Information:
Title
Evaluation of bone quality
Description
Histomorphometric analysis (Masson's Trichrome stain)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Horizontal ridge dimensional changes
Description
Measuring the linear horizontal changes using CBCT
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Eligible patients aged 18 years or older with partial edentulism of the mandible
The residual ridge width must be 4 mm or less
Intra-oral donor sites should be available in the external oblique ridge and symphyseal area
Exclusion Criteria:
Patients with general contraindications for implant surgery such as uncontrolled diabetes
Irradiation of the head and neck region
Intravenous bisphosphonate
Pregnancy
Smokers, alcoholics and drug abusers
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Abbassia
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Cortical Bone Plate Versus Cortico-cancellous Block Graft
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