Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05987930 |
Other study ID # |
1611 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 20, 2023 |
Est. completion date |
December 20, 2023 |
Study information
Verified date |
January 2024 |
Source |
Tanta University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Twenty patients with benign mandibular lesion will be included in this study. the patient
will be divided randomly (10 patients each group). Group I the lesion will be treated using
bone lid technique. Group II the lesion will be treated using the standard technique. The
patients will be received, clinically and radiologically examined, and managed at the Oral
and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The patients will be evaluated clinically to evaluate healing and radiographically using cone
beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six
months later
Description:
Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid
technique performed using a piezoelectric device versus the traditional technique in patients
requiring excision of the mandibular bony lesions
Materials & Methods: Twenty patients with mandibular lesion will be included in this study.
the patient will be divided randomly (10 patients each group). Group I the lesion will be
treated using bone lid technique. Group II the lesion will be treated using the standard
technique. The patients will be received, clinically and radiologically examined, and managed
at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using
Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.
Surgical procedure: A full thickness flap will be elevated in both groups to achieve access
to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond
the actual extension of lesion in radiograph using piezoelectric device to secure a latter
repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an
internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in
saline. After excision of the lesion, the bony lid will be repositioned to its original
position and fixed to the bone with an absorbable suture.
In group II the bone will be removed buccally using surgical bur then the lesion is removed.
Finally, the flap will be sutured in both groups.
Postoperative evaluation: The patients will be evaluated clinically regarding healing,
presence of infection, inflammation, necrosis, or bone exposure each week for one month then
monthly for six months.
Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the
repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone
defect bone healing and volume of the defect.
All selected cases of both groups b were went for CBCT scan using fixed exposure parameters
(Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same
axial slicing to evaluate the following
1. Cyst area in coronal view for posterior region and sagittal view for anterior region
2. Evaluating lesion location by making perpendicular line from alveolar crest on the
occlusal plane and measuring the distance from alveolar crest to the lesion using
(Coronal view posterior, sagittal anterior).
3- recurrence of lesion , integration of buccal cortex 4- bone density