Skip to main content
OpenTrials
Completed

NCT Number: NCT05401994

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mandibular Fractures Craniocerebral Trauma Facial Injuries Fractures, Bone Jaw Fractures Maxillofacial Injuries Nervous System Diseases Skull Fractures Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, 35516, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

screw retained arch bar

Procedure

maxillomandibular fixation with bone screwed arch bar

conventional Erich's Arch Bar

Procedure

maxillomandibular fixation with conventional arch bar fixed to the teeth

Primary outcomes

  1. duration of surgical procedure in minutes

    Time frame: intraoperative

    Duration between the starting of fixation and complete fixation of fracture

  2. maxillomandibular fixation stability in nominal scale(stable-unstable)

    Time frame: immediately postoperative

    stability after fixation

  3. maxillomandibular fixation stability in nominal scale(stable-unstable)

    Time frame: 4-6 weeks

    stability after fixation

  4. oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)

    Time frame: immediately postoperative

    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.

  5. oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)

    Time frame: 4-6 weeks

    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.

Secondary outcomes

  1. number of iatrogenic injuries

    Time frame: intraoperative

    iatrogenic injuries to teeth and gingiva

  2. number of needle and wire stick injuries

    Time frame: intraoperative

    injuries to the surgeon and the assistants.

  3. pain assessment using numeric rating scale (NRS)

    Time frame: immediately postoperative

    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").

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.