- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06313229
Simultaneous Implant Placement With Vertical and Horizontal Bone Augmentation
Simultaneous Versus Staged Implant Placement With Vertical and Horizontal Bone Augmentation Using Autogenous Cortical Bone Plates Combined With a Mixture of Platelet-rich Fibrin and Allobone Grafts.
Study Overview
Status
Conditions
Detailed Description
Sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. A variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. The present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects.
Forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. The two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. Radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kafrelsheikh
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Kafr ash Shaykh, Kafrelsheikh, Egypt, 214312
- faculty of dentistry, kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Good general health at the time of surgery
- At least 3 months of healing after tooth extraction
- Horizontally and vertical compromised alveolar ridges
Exclusion Criteria:
- Thick cortex in the labial/buccal with less cancellous bone inside;
- Obvious undercut on the labial/buccal side
- Uncontrolled periodontal conditions or other oral disorders;
- history of radiotherapy in the head and neck region
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Staged implant placement approach
the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft.
6 months later the implant was placed in the grafted site.
|
the deficient ridge was grafted first followed by implant placement after 6-monthes
|
|
Experimental: Simultaneous implant placement approach
the bone defect was grafted using bone plates buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft combined with simultaneous implant placement.
|
the deficient ridge was grafted and followed by implant placement simultaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stability Quotient of Implants (SQI)
Time Frame: 12-month.
|
The implant stability was recorded using Osstell TM.
Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.
|
12-month.
|
|
Horizontal bone dimensions (HBDs)
Time Frame: 12-month.
|
The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.
|
12-month.
|
|
Peri-implant Bone Density (PBD)
Time Frame: 12-month.
|
For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.
|
12-month.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walid AH Elamrousy, PhD, Faculty of Oral and Dental Medicine, Kafrelsheikh University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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