- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06529653
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yasmin ahmed, B.D.S
- Phone Number: 01065273456
- Email: yasmin.ahmed@dentistry.cu.edu.eg
Study Contact Backup
- Name: Mohamed Omara, PHD
- Phone Number: 01144452862
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- oral and maxillo facial Surgery Department; Faculty of dentistry, Cairo University.
-
Contact:
- yasmin ahmed, B.D.S
- Phone Number: 01065273456
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
All patients possessed partially edentulous anterior maxillary ridge with the following criteria
- The anterior maxillary vertical dimension was more than ten mm measured from the alveolar crest to the basal bone of the maxilla.
- The horizontal alveolar dimension varies from 3-5 mm at the crest and 6-8 mm at the basal part of the ridge measured from the labial cortex to the lingual cortex.
- All patients were free from any medical conditions that may affect bone healing .
- No local pathosis that may interfere with bone healing.
No previous grafting procedures at the indicated edentulous ridge.
-
Exclusion Criteria:
1- Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: intervention group
the group using an autogenous bone wedge harvested from the chin interpositioned between split cortices in the anterior maxilla to manage the horizontal deficiency of the ridge.
|
autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge
|
|
Other: control group
the group used mixed autogenic and xenogenic bone particles that interposed between split cortices in anterior maxilla to manage the horizontal deficiency of the ridge
|
autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative
Time Frame: 6 months
|
after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of areas of new bone (%)
Time Frame: 6 months
|
The harvested core biopsies would be stained with H&E and Massons trichrome stain and be microscopically examined to determine percentage areas of newly formed bone
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
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
Other Study ID Numbers
- ridge splitting
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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