Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

Mandible Tumor Clinical Trial

Official title:

Lecturer of Oral and Maxillofacial Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987930
• Other study ID #: 1611
• Status: Completed
• Phase: N/A
• 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
• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 20, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

age = 6 years

• presence of bony lesion (cysts, benign tumors, odontoma) located in mandibular region,

• the existence of a normal residual buccal cortical plate with the adequate thickness (=1 mm) at least at the periphery of buccal cortical plate

Exclusion Criteria:

• • patients taking medications that affect bone metabolism,

• patients underwent head and neck radiotherapy

Related Conditions & MeSH terms

• Mandible Tumor
• Mandibular Diseases

Intervention

Device:
• bone lid technique
group I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex
• standard technique
group II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of pain evaluated clinically in both groups	using visual analogue scale:0 represent no pain and 10 represents the highest level of pain	one-two weeks
Primary	soft tissue healing evaluated clinically in both groups	adequate means closed or inadequate means open wound	one week
Primary	infection evaluated clinically in both groups	1 means mild,2 means moderate or3 means sever infection	one week-one month
Primary	cyst area calculation radiographically in both groups	using CBCT to measure the area in mm2	six months
Primary	measuring the distance between the lesion and alveolar crest in both groups	making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.	six months
Primary	density of bone calculated radiographically in both groups	CBCT to measure density (D1> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield	six months
Secondary	inflammation clinically in both groups	0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation	one week
Secondary	integration of buccal cortex radigraphically in both groups	presence of radiolucency around of buccal cortex or not	six months