Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

Lecturer of Oral and Maxillofacial Surgery

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

Study Overview

• Status: Completed
• Conditions: Mandibular Diseases; Mandible Tumor; Mandible Cyst
• Intervention / Treatment: Device: bone lid technique; Device: standard technique

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 3111
    • Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bone lid technique; ten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place	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
Experimental: standard technique; ten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
cyst area calculation radiographically in both groups	using CBCT to measure the area in mm2	six months
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
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
soft tissue healing evaluated clinically in both groups	adequate means closed or inadequate means open wound	one week
infection evaluated clinically in both groups	1 means mild,2 means moderate or3 means sever infection	one week-one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammation clinically in both groups	0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation	one week
integration of buccal cortex radigraphically in both groups	presence of radiolucency around of buccal cortex or not	six months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: mona s sheta, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: mandibular lesions; bone lid technique; standard technique
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Mandibular Diseases
• Other Study ID Numbers: 1611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No