Back to resultsPiezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation
Primary Purpose
Alveolar Bone Loss
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
silica-calcium phosphate nanocomposite SCPC
freezed dried bone
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
- Augmented area length in the mesial-distal direction of less than 20 mm.
- Adequate physically healthy condition.
Exclusion Criteria:
- A systemic disease that would contraindicate oral surgical treatment.
- Treated patients who had undergone therapy involving radiation
- Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
- Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A will be treated with the buccal plate repositioning technique and grafted with SCPC.
Group B will be similarly managed and grafted using DFDBA
Outcomes
Primary Outcome Measures
change in alveolar ridge width
All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05317039
Brief Title
Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation
Official Title
Evaluation of Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation Comparing Between Two Different Grafting Materials (a Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
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
Achieving prosthetically driven implant placement is a highly predictable treatment modality with reliable long-term results. Different surgical procedures have been used as a solution for reconstructing of the alveolar ridge with deficient volume. In the present study we demonstrate a modified alveolar ridge split technique for horizontal alveolar ridge augmentation (buccal plate repositioning technique) using the piezotome surgery. Evaluation of the effect of silica-calcium phosphate nanocomposite (SCPC) graft material versus demineralized freeze dried bone allograft (DFBA) in horizontal alveolar ridge augmentation before implant insertion will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A will be treated with the buccal plate repositioning technique and grafted with SCPC.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B will be similarly managed and grafted using DFDBA
Intervention Type
Other
Intervention Name(s)
silica-calcium phosphate nanocomposite SCPC
Intervention Description
Patients will be treated with the buccal plate repositioning technique and grafted with SCPC then the grafted defect will be covered with a platelet-rich fibrin membrane.
Intervention Type
Other
Intervention Name(s)
freezed dried bone
Intervention Description
Patients will be treated with the buccal plate repositioning technique and grafted using DFDBA. then the grafted defect will be covered with a platelet-rich fibrin membrane.
Primary Outcome Measure Information:
Title
change in alveolar ridge width
Description
All patients will receive a CBCT scan; immediately after surgery and at 6 months post-operatively. The images will be analyzed using OnDemand3D software (Cybermed Inc) CBCT analyzing software and compared to the pre-operative scan for alveolar ridge width evaluation.
Time Frame
at baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with horizontal atrophy of the posterior mandible with pristine residual alveolar crest width from 2 to 4 mm.
Augmented area length in the mesial-distal direction of less than 20 mm.
Adequate physically healthy condition.
Exclusion Criteria:
A systemic disease that would contraindicate oral surgical treatment.
Treated patients who had undergone therapy involving radiation
Patients who had received bone resection as part of an oncological treatment after a bone augmentation procedure.
Patients are subjected to intravenous and/or oral bisphosphonate therapy after the bone augmentation procedure.
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Piezosurgical Buccal Plate Repositioning Technique for Horizontal Alveolar Ridge Augmentation
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