Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 5:04 PM
Study NCT ID:
NCT06416605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autogenous Tooth Graft for Ridge Augmentation
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Tooth Shell Versus Bone Shell Technique For Horizontal Maxillary Alveolar Ridge Augmentation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.
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.
• 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: