- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416605
Autogenous Tooth Graft for Ridge Augmentation
Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups:
• Group I: Horizontal bone augmentation will be done by bone shell technique.
• Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique.
Evaluation:
A-Clinical evaluation:
- All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation.
- The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa.
- A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site.
B-Radiographic evaluation
•Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws.
Radiographic analysis:
Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Heba Elsheikh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.
2- Age ranging from 18_50 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.
Exclusion Criteria:
1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,
- etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
Horizontal bone augmentation will be done by bone shell technique
|
using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant
|
Experimental: group B
Horizontal bone augmentation will be done by autogenous tooth shell technique
|
using tooth graft or bone graft to increase alveolar ridge width to be able to insert dental implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
horizontal alveolar width measurements
Time Frame: 6 months
|
Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- A03030123
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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