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

N/ACompletedNCT05401994

Mansoura University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mandibular Fractures

Interventions

screw retained arch barPROCEDURE

maxillomandibular fixation with bone screwed arch bar

conventional Erich's Arch BarPROCEDURE

maxillomandibular fixation with conventional arch bar fixed to the teeth

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mansoura university

Al Mansurah, Egypt

Outcomes

Primary Outcomes

duration of surgical procedure in minutes

Duration between the starting of fixation and complete fixation of fracture

Time frame: intraoperative

maxillomandibular fixation stability in nominal scale(stable-unstable)

stability after fixation

Time frame: immediately postoperative

maxillomandibular fixation stability in nominal scale(stable-unstable)

stability after fixation

Time frame: 4-6 weeks

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.

Time frame: immediately postoperative

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.

Time frame: 4-6 weeks

Secondary Outcomes

number of iatrogenic injuries

iatrogenic injuries to teeth and gingiva

Time frame: intraoperative

number of needle and wire stick injuries

injuries to the surgeon and the assistants.

Time frame: intraoperative

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").

Data from ClinicalTrials.gov

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