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Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

Not Applicable
Completed
Conditions
Mandible Tumor
Mandible Cyst
Mandibular Diseases
Interventions
Device: standard technique
Device: bone lid technique
Registration Number
NCT05987930
Lead Sponsor
Tanta University
Brief 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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
standard techniquestandard techniqueten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion
bone lid techniquebone lid techniqueten 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
Primary Outcome Measures
NameTimeMethod
measuring the distance between the lesion and alveolar crest in both groupssix months

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.

density of bone calculated radiographically in both groupssix months

CBCT to measure density (D1\> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield

soft tissue healing evaluated clinically in both groupsone week

adequate means closed or inadequate means open wound

infection evaluated clinically in both groupsone week-one month

1 means mild,2 means moderate or3 means sever infection

cyst area calculation radiographically in both groupssix months

using CBCT to measure the area in mm2

degree of pain evaluated clinically in both groupsone-two weeks

using visual analogue scale:0 represent no pain and 10 represents the highest level of pain

Secondary Outcome Measures
NameTimeMethod
inflammation clinically in both groupsone week

0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation

integration of buccal cortex radigraphically in both groupssix months

presence of radiolucency around of buccal cortex or not

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University

🇪🇬

Tanta, Egypt

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