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

COMPARATIVE EVALUATION OF TREATMENT OUTCOMES AFTER FIXATION OF CONDYLAR FRACTURES WITH 3-D MINIPLATE VERSUS CONVENTIONAL MINIPLATE: A RANDOMISED CLINICAL TRIAL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041581

Enrollment

Registered

2022-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: 3-D MINIPLATES: 3-D TITANIUM MINIPLATES FOR OPEN REDUCTION AND INTERNAL FIXATION OF CONDYLAR FRACTURES DURATION OF THERAPHY : 3MONTHS (3 MONTHS FOLLOWUP) Control Intervention1: CONVENT

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDR TANVY SUBIR SANSGIRI

RURAL DENTAL COLLEGE,PIMS

nirav_seemit@yahoo.com9823129828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026