NCT04396054

Brief Summary

This study is a prospective randomized controlled clinical trial. It was performed on sixteen patients with anterior mandibular fractures, to compare Double Y-shaped plates and Lag Screws in fracture fixation from clinical and radiographic perspectives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

September 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 9, 2020

Last Update Submit

May 15, 2020

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (2)

  • progress of fracture healing in the postoperative period

    Measurement of bone density in the fracture line using CBCT at 6 points and calculation of mean bone density

    after 6 months

  • Sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side

    Detection of nerve injury by examining sensory nerve function using dental probe to assess sensory changes along mental nerve distribution and comparing it to the contralateral side

    up to 6 months

Study Arms (2)

Lag Screws

ACTIVE COMPARATOR

Group 1: underwent open reduction and internal fixation using two lag screws.

Device: Lag Screws

Double Y-shaped plates

ACTIVE COMPARATOR

Group 2: underwent open reduction and internal fixation using double Y-shaped plates.

Device: double Y-shaped plates

Interventions

Lag ScrewsDEVICE

Method of internal fixation

Lag Screws
double Y-shaped platesDEVICE

Method of internal fixation

Double Y-shaped plates

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both genders
  • with age ranging from 25 to 45 years,
  • suffering from anterior fractures of the mandible (symphyseal or parasymphyseal)

You may not qualify if:

  • old fractures,
  • infected fractures
  • comminuted fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Alexandria, 21411, Egypt

Location

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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 20, 2020

Study Start

September 3, 2019

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

May 20, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)