NCT04443998

Brief Summary

Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 16, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

June 20, 2020

Last Update Submit

June 20, 2020

Conditions

Mandibular Fractures

Outcome Measures

Primary Outcomes (4)

  • Change in radiodensitometric measurements

    cone-beam computerized tomograms (CBCT) used to analyze the mean bone density at the site of fracture

    at 3rd, 6th months

  • change in maximal mouth opening

    maximal interincisal opening between maxillary and mandibular central incisors.

    1 week, 2 weeks, 1 month, 6 weeks, and 3 months

  • change in occlusion

    Any occlusal disturbance including open bite or improper tooth contact will be recorded

    1 week, 2 weeks, 1 month, 6 weeks, and 3 months

  • change in pain level

    Pain: will be measured on Visual Analogue Scale (VAS). The patients will be asked to rate their postoperative pain on a 4-point scale (0= none, 1= slight, 2= moderate, 3- severe)

    1 week, 2 weeks, 1 month, 6 weeks, and 3 months

Study Arms (1)

Bone reduction forceps

EXPERIMENTAL
Device: Bone reducion forceps

Interventions

Bone reducion forcepsDEVICE

Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction

Bone reduction forceps

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged from 20 to 45 years will be included.
  • Patients suffered from recent and uninfected.
  • Patients with isolated mandibular fractures.

You may not qualify if:

  • Medically compromised patients that will be not fit for surgery.
  • Edentulous patients.
  • Non-displaced
  • Comminuted fracture with bone loss
  • Old fracture, more than 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 20, 2020

First Posted

June 23, 2020

Study Start

October 16, 2019

Primary Completion

August 18, 2020

Study Completion

September 1, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

EG(1)