Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

Mandibular Fractures Clinical Trial

Official title:

Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05401994
• Other study ID #: A03080921
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation

Description:

2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The patients age ranges from 18 to 50 years.

2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.

3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.

Exclusion Criteria:

• 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.

Related Conditions & MeSH terms

• Mandibular Fractures

Intervention

Procedure:
• screw retained arch bar
maxillomandibular fixation with bone screwed arch bar
• conventional Erich's Arch Bar
maxillomandibular fixation with conventional arch bar fixed to the teeth

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of surgical procedure in minutes	Duration between the starting of fixation and complete fixation of fracture	intraoperative
Primary	maxillomandibular fixation stability in nominal scale(stable-unstable)	stability after fixation	immediately postoperative
Primary	maxillomandibular fixation stability in nominal scale(stable-unstable)	stability after fixation	4-6 weeks
Primary	oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)	the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.	immediately postoperative
Primary	oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)	the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.	4-6 weeks
Secondary	number of iatrogenic injuries	iatrogenic injuries to teeth and gingiva	intraoperative
Secondary	number of needle and wire stick injuries	injuries to the surgeon and the assistants.	intraoperative
Secondary	pain assessment using numeric rating scale (NRS)	participants rated their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	immediately postoperative