TREATMENT OUTCOMES OF 3D MINIPLATE USED FOR FIXATION OF CONDYLAR FRACTURES

Phase 3

Conditions: Health Condition 1: K039- Disease of hard tissues of teeth,unspecifiedHealth Condition 2: V299- Motorcycle rider (driver) (passenger) injured in unspecified traffic accident

Registration Number: CTRI/2022/04/041581

Lead Sponsor: PRAVARA INSTITUTE OF MEDICAL SCIENCES

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients with diagnosed Condylar neck/Subcondylar with or without other mandible fractures(according to Lindahls classification)

2.Patients with dentition complete enough to apply Erichâ??s arch bars

3.Patients with absent or minimal dental restorations

4.Presence of Molar relation for placement of bite force measurement device.

5.Patients above 18 years of age and of any gender.

6.Patients willing to give written and informed consent before any study specific procedure.

7.Hemodynamically stable patients

Exclusion Criteria

1.Patients with edentulous ridges.

2.Patients with associated other facial bone fractures.

3.Patients with head injury or any neurosensory deficit

4.Presence of periodontally compromised teeth.

5.Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS

6.Known case of tuberculosis/AKT therapy, patients on long term steroid therapy, immune compromised patients, patients having chronic diseases, uncontrolled diabetes.

7.Subjects having psychiatry morbidity

8.Subjects who declared unfit for general anaesthesia by anaesthetics as SOP

9.Subject who are planning to become pregnant within five months of surgery, lactating mother

10.Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BITE FORCE, TIME PERIOD FOR RECOVERY OF BITE FORCE(IN DAYS),OCCLUSION, STABILITY OF FIXATION,FUNCTION: CHEWING EFFICIENCYTimepoint: POST-OP DAY 1, 1ST WEEK, 1ST MONTH, 3RD MONTH

Secondary Outcome Measures

Name	Time	Method
COMPLICATIONS : PLATE FRACTURE, SCREW LOOSENING, WOUND DEHISCENCE, TMJ PAIN, CLICKING,FACIAL NERVE WEAKNESS; SURGICAL TIME, SURGEONS DIFFICULTY INDEX, INTERINCISAL MOUTH OPENING, LATERAL DEVIATION, RADIOGRAPHIC ASSESMENT ON OPG, WHO QOL SCALETimepoint: POST-OP DAY 1, 1ST WEEK, 1ST MONTH, 3RD MONTH