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Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

Lecturer of Oral and Maxillofacial Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987930
Enrollment
24
Registered
2023-08-14
Start date
2023-06-20
Completion date
2023-12-20
Last updated
2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible Cyst, Mandible Tumor, Mandibular Diseases

Keywords

mandibular lesions, bone lid technique, standard technique

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

Interventions

DEVICEbone 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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
density of bone calculated radiographically in both groupssix monthsCBCT to measure density (D1\> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield
cyst area calculation radiographically in both groupssix monthsusing CBCT to measure the area in mm2
measuring the distance between the lesion and alveolar crest in both groupssix monthsmaking 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.
degree of pain evaluated clinically in both groupsone-two weeksusing visual analogue scale:0 represent no pain and 10 represents the highest level of pain
soft tissue healing evaluated clinically in both groupsone weekadequate means closed or inadequate means open wound
infection evaluated clinically in both groupsone week-one month1 means mild,2 means moderate or3 means sever infection

Secondary

MeasureTime frameDescription
integration of buccal cortex radigraphically in both groupssix monthspresence of radiolucency around of buccal cortex or not
inflammation clinically in both groupsone week0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026