NCT06099431

Brief Summary

The purpose of this study is to evaluate the reliability of using mandibular osteosynthesis a 2.3mm reconstruction bone plate in the maintenance of the space, contour, and mandibular bone preservation during marginal mandibular resection.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

October 9, 2023

Last Update Submit

April 7, 2025

Conditions

Mandible Tumor

Keywords

Reconstructionbone plateMandible

Outcome Measures

Primary Outcomes (3)

  • Degree of pain

    The degree of pain is determined during the follow up periods according the scale of Kerkmanov and Nordenram , Mild: require one tablet of analgesics three times/ day, Moderate: require two tablets of analgesics three times/ day, Severe: require injective analgesics.

    1 month

  • Rate of inflammation

    The wounds were inspected accurately post-operatively for detecting the proper healing using inflammation score scale, 0 no inflammation,1-3 mild inflammation, 4-7,moderate inflammation, 8-10 sever inflammation

    1 month

  • Rate of Infection

    using Infection score scale , mild infection which responds to antibiotics, only without the need for incision and drainage, moderate infection which needs for incision and drainage and severe infection which needs for incision and drainage in addition to hardware removal.

    6 months

Secondary Outcomes (1)

  • Axial and coronal computed tomography

    6 month

Study Arms (1)

Surgery/Device

OTHER

Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate

Procedure: Mandibular marginal resection and reconstructionDevice: mandibular osteosynthesis a 2.3mm reconstruction bone plate

Interventions

Mandibular marginal resection and reconstructionPROCEDURE

Intraoral buccal and lingual incisions 2-3 mm away from the free gingival margins were carried out around the teeth to be included in the resection. The osteotomy lines were marked using a long shank surgical tapered fissure bur. The osteotomies completed and the resected segment was removed.

Surgery/Device
mandibular osteosynthesis a 2.3mm reconstruction bone plateDEVICE

a 2.3 mm reconstruction bone plate was then fit in place and fixed to both the proximal and distal segments

Surgery/Device

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection

You may not qualify if:

  • systemic disease affect primary wound healing malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 3111, Egypt

Location

MeSH Terms

Conditions

Mandibular Neoplasms

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Jaw NeoplasmsSkull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesMandibular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Mohamed K Allam, Ass prof

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 25, 2023

Study Start

December 22, 2022

Primary Completion

December 10, 2025

Study Completion

December 30, 2025

Last Updated

April 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)