Comparison of bone supported EZY arch bars, Intermaxillary Fixation Screws and Conventional Erich arch bar in Maxillo-Mandibular fixation- A Randomised Control Study

Not yet recruiting

• Conditions: Fracture of mandible, (2) ICD-10 Condition: S026||Fracture of mandible, (3) ICD-10 Condition: V229||Unspecified motorcycle rider injured in collision with two- or three-wheeled motor vehicle in traffic accident,

• Registration Number: CTRI/2022/07/043839
• Lead Sponsor: Acchuthakrishnan K A

Brief Summary

Ø To evaluate Bone supported Ezy arch bars, IMF screws and Erich’s arch bar in Maxillo-Mandibular fixation in terms of surgical time taken, glove perforation post operative occlusion, IMF stability, oral hygiene, screw assesment, mucosal ulcerations and non vitality characteristics at preoperative, Ist week, 6th week postoperatively Radiological assessment-  loss of screw, screw breakage, screw covered by mucosa and iatrogenic damage to dental roots in IMF screws and EZY arch bars postoperatively. Functional assessment- post operative occlusion and IMF stability were recorded as satisfactory and non satisfactory based on Angle’s classification. Mucosal ulcerations caused by the hardware were assessed. Pre and post operative tooth vitality by the help of Electrical Pulp Tester. Needle stick injury or perforations assessed by water inflation method. Intraoperative assessment-. Surgical time-Stopwatch. Oral hygiene assessment-  OHI-S   given by Greene and vermillion.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-07
• Study Start: 2022-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Patients who are consented to participate.
• 2.Patient’s in the age group of 16-60 years.
• Patient’s with unilateral mandibular parasymphysis fracture.

Exclusion Criteria

1.Edentulous patients with underlying medical conditions 2.Pathologic and communited fracture of mandible 3.Patients with multiple fractures 4.Patient with fracture in other parts of body 5.Patients with primary and mixed dentition was excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time required for the placement of device.	1st week and 6th week.
3.Post operative occlusion ( Andrews six Keys of Occlusion)	1st week and 6th week.
2.Pre operative occlusion ( Andrews six Keys of Occlusion)	1st week and 6th week.

Secondary Outcome Measures

Name	Time	Method
1.Glove Perforation during Placement of the Device	2.Vitality of the teeth

Trial Locations

Locations (1)

Karpaga Vinayaga Institute of Dental Sciences; 🇮🇳 Kancheepuram, TAMIL NADU, India

Karpaga Vinayaga Institute of Dental Sciences

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Acchuthakrishnan

Principal investigator

7904307597

acchu7.ak@gmail.com