NCT07403708

Brief Summary

Background: Condylar fracture is one of mandibular fracture which accounts for 20-35%. It is the most controversial fractures regarding diagnosis and management. For several years, surgeons preferred closed reduction over open reduction to avoid surgical complications. Closed reduction may have late complications, the preference started to change towards open treatment. A Transmasseteric Anteroparotid (TMAP) approach for open treatment of condylar fractures overcomes the problems of facial nerve injury of other approaches. Aim: Comparing the Transmasseteric Antroparotid approach(TMAP) to the Transparotid (TP) approach in management of subcondylar fractures regarding the facial nerve affection, parotid fistula, reduction angulation, pain, duration of the surgery, occlusion and patient satisfaction with the scar. Materials and Methods: Twenty patients with subcondylar fracture will be divided randomly into two equal groups. Group1(study group): Transmasseteric Antroparotid approach. Group2 (control group): Retromandibular Transparotid approach. Patients will be followed up for 3 months to assess facial nerve injury, pain, occlusion and patient's scar satisfaction . Results: data will be collected, tabulated and statistically analysed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 5, 2026

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • facial nerve injury

    immediate postoperative

Secondary Outcomes (1)

  • approach time

    interaoperative

Study Arms (2)

transmasseteric anteroparotid approach

EXPERIMENTAL
Procedure: transmasseteric anteroparotid approach

transparotid approach

ACTIVE COMPARATOR
Procedure: transparotid approach

Interventions

facial nerve and parotid dissection to reach condyle

transparotid approach

safer approach for condylar fracture

transmasseteric anteroparotid approach

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including:
  • Difficulty of obtaining adequate occlusion by closed method. Radiological signs of the following:
  • Deviation of the he fragments from the axis of the ascending ramus in medial or lateral direction more than 10°. (28)
  • Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.
  • Dislocation of the condyle from the glenoid fossa.

You may not qualify if:

  • Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems. 2. Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

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
Dr.

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 11, 2026

Study Start

January 1, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations