Comparing Two Methods to Stabilize Broken Jaw Bones: Traditional Wire Braces vs. Screw-Fixed Braces

Phase 2

Not yet recruiting

• Conditions: Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible,

• Registration Number: CTRI/2025/05/086773
• Lead Sponsor: SELF

Brief Summary

Erich’s arch bar has traditionally been used for intermaxillary fixation (IMF) in maxillofacial trauma. However, it presents risks like wire prick injuries, glove tears, and increased operative time. The screw-retained hybrid arch bar is proposed as a safer and more efficient alternative.

AIM OF THE STUDY To evaluate and compare the effectiveness of Erich’s arch bar and self-drilling screw retained hybrid arch bar for intermaxillary fixation in the management of maxillofacial trauma.

OBJECTIVES OF STUDY Compare occlusal stability

Compare placement and removal times

Evaluate operator and assistant injuries

Assess patient soft tissue injury and glove tear incidence

METHODOLOGY

**Inclusion:** Patients aged 18–65 with maxillofacial trauma requiring IMF.

**Exclusion:** Patients outside the age range, those unwilling to consent, or with contraindications for arch bar use.

Assessment Parameters:

Preoperative**:** Occlusion, tooth vitality, radiological evaluation

Intraoperative: Time, ergonomics, glove/wire injuries

Postoperative**:** Removal time, tooth morbidity, screw/wire loosening, soft tissue status

After the placement of arch bars in both groups , parameters are assessed such as time of placement, removal, occlusal stability, operator and assistant injury, wire prick injury, soft tissue injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-30
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Participants aged 18-65 years requiring arch bar fixation.
• Participants who are willing to give consent for the study.

Exclusion Criteria

• Participants aged below 18 years and above 65 years.
• Patients with the conditions where arch bar fixation is contraindicated.
• Participants who are not willing to give informed and written consent for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the occlusal stability provided by self drilling screw retained hybrid arch bar and Erich’s arch bar.	Baseline, 4 weeks
To assess and compare the time taken for the placement and removal of self drilling screw retained hybrid arch bar and Erich’s arch bar.	Baseline, 4 weeks
To assess and compare the injury to operator and assistant.	Baseline, 4 weeks
To assess intra operative and post operative soft tissue injury to the patient.	Baseline, 4 weeks
To assess and compare the incidence of glove tear.	Baseline, 4 weeks

Secondary Outcome Measures

Name	Time	Method
To see the wire and screw loosening	Baseline and after 4 weeks

Trial Locations

Locations (1)

Kamineni Institute of Dental Sciences; 🇮🇳 Nalgonda, TELANGANA, India

Kamineni Institute of Dental Sciences

🇮🇳Nalgonda, TELANGANA, India

Dr Binshi Biju

Principal investigator

9063544398

binshibiju964@gmail.com