NCT06898710

Brief Summary

The collected patients according to the eligibility criteria will be randomly distributed into one of these groups: Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group). Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group). The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 21, 2025

Last Update Submit

March 21, 2025

Conditions

Mandible Fracture

Outcome Measures

Primary Outcomes (1)

  • inter condylar distance

    3 months

Study Arms (2)

z miniplate with lingual extension

EXPERIMENTAL
Procedure: z mini plate with lingual extension

two mini plate

ACTIVE COMPARATOR
Procedure: conventional 2 mini plates

Interventions

z mini plate with lingual extensionPROCEDURE

patient with class III mandible fracture will be treated with patient specific z mini plate with lingual extension

z miniplate with lingual extension
conventional 2 mini platesPROCEDURE

patient with class III mandible fracture will be treated with conventional 2 mini plates

two mini plate

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Class III mandibular fracture
  • medically stable patient
  • aged above 21 years
  • no medical condition affect the bone healing

You may not qualify if:

  • absence of other facial trauma, mandibular condylar fracture
  • patient refuse the follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw FracturesMaxillofacial InjuriesFacial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesSkull FracturesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 21, 2025

First Posted

March 27, 2025

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 1, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03