Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions

NCT05987930 | Completed

• 1 other identifier: 1611
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Mandible Cyst; Mandible Tumor; Mandibular Diseases

Keywords

mandibular lesions; bone lid technique; standard technique

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Secondary Outcomes (2)

• inflammation clinically in both groups

  one week

• integration of buccal cortex radigraphically in both groups

  six months

Study Arms (2)

bone lid technique

EXPERIMENTAL

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

standard technique

EXPERIMENTAL

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

Interventions

bone lid technique DEVICE

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

bone lid technique

standard technique DEVICE

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

standard technique

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients taking medications that affect bone metabolism,
• patients underwent head and neck radiotherapy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 3111, Egypt

Location

Related Publications (1)

• Sheta MS, Ghouraba RF, Ibrahim MT. Bone lid technique versus standard technique for treatment of mandibular lesions. BMC Oral Health. 2024 Aug 2;24(1):875. doi: 10.1186/s12903-024-04594-y.

  PMID: 39095818 DERIVED

MeSH Terms

Conditions

Mandibular Neoplasms; Mandibular Diseases

Condition Hierarchy (Ancestors)

Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• mona s sheta

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Surgery Department

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 14, 2023
• Study Start: June 20, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 20, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

EG (1)