Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture

October 6, 2024 updated by: Shanza Rehman, Services Institute of Medical Sciences, Pakistan

Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture in Terms of Mouth Opening and Radiographic Gap and Displacement

The goal of this clinical trial is to learn if transbuccal technique for mandibular angle fracture is better than transoral technique. The main questions it aims to answer are:

  • Does transbuccal technique provide better mouth opening than transoral technique
  • Radiographic gap and displacement between fracture lines is more prevalent in transoral technique than transbuccal technique postoperatively Researcher will compare both the techniques to see if transbuccal technique works better than transoral technique

Participants will:

  • Be assessed 1 week , 1 month and 3 months postoperatively
  • Their mouth opening will be assessed by measuring interincisal opening with ruler
  • Radiographic gap between fracture segments and displacement of fractured segments will be measured on OPG through ruler

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE: To compare the efficacy of transoral versus transbuccal technique for fixation of mandibular angle fracture in terms of mouth opening and radiographic gap and displacement.

OPERATIONAL DEFINITIONS:

MANDIBLE ANGLE FRACTURE:Fracture line in area bound from the anterior border of the masetter(distal of 2nd molar) to posterior border of the masetter assessed clinically through palpation and radiographically through OPG and PA mandible.

EFFICACY: The efficacy of the two procedures will be assessed on 1 week, 1 month, 3 months with following outcomes.

  1. MOUTH OPENING: Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
  2. GAP BETWEEN FRACTURE SEGMENTS: Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
  3. DISPLACEMENT OF FRACTURE SEGMENTS: Presence of step between distal and proximal segments in vertical plane at the lower border on OPG.

HYPOTHESIS: Transbuccal approach will have better functional post-operative mouth opening, radiographic gap and displacement compared to transoral fixation technique in patients with mandibular angle fracture.

MATERIALS AND METHODS:

STUDY DESIGN: Prospective randomized clinical study. SETTING:Oral and maxillofacial surgery department, emergency and OPD of Services Hospital Lahore.

DURATION OF STUDY: Six months after approval of synopsis. SAMPLE SIZE: Sample size was calculated through openepi calculator for sample size for % frequency in a population(random sample) Population size=1000000 Anticipated % frequency(p)=50 Confidence limits=12% absolute precision Design effect=1.0 for random sample Sample size for 95% confidence level=67 Sample size in each group=n=34

SAMPLING TECHNIQUE: Nonprobability purposive sampling technique.

SAMPLE SELECTION:

DATA COLLECTION PROCEDURE:

METHODS OF DATA COLLECTION:Patients fulfilling inclusion criteria will be taken from emergency and OPD of Services Hospital Lahore and will be randomized into 2 groups group A( transoral technique) and group B (transbuccal technique) by lottery method after taking informed consent from them by briefing them about study, research protocol and risk-benefit ratio.Diagnosis and treatment plan will be made based on history, clinical examination and radiographic findings of OPG and PA mandible. Procedure will be done by single surgical team. In Group A transoral approach inferior alveolar nerve block and buccal nerve block will be given by 2% xylocaine with 1:100000 adrenaline. Incision will be made with surgical blade no 15 from gingival crevices of molars to ascending ramus. Fracture segments will be reduced alongwith MMF. A 5-hole 2mm miniplate with 2 holes anterior and 2 holes posterior to fracture line will be screwed to external oblique ridge and MMF will be removed and incision line will be closed. In Group B tranbuccal technique same procedure will be performed till fracture reduction and MMF after which extraorally a stab incision will be made with scalpel blade parallel to relaxed resting skin tension lines through which the cannula with a trocar will be inserted through facial tissue down to bone. Transbuccal instrument system will cionsist of transbuccal guide, mountable retractor, drill sleeve, drill guide, and 2mm drill bit. A 2mm titanium miniplate will be placed along buccal cortex and screwed through trocar system. MMF will be removed and incision line closed.

DATA COLLECTION TOOLS:All study variables will be assessed by single person at 1 week,1 month and 3 months post op.Clinical parameters will be assessed through proforma/questionnaire. Radiological parameters will be assessed through OPG, PA mandible.

DATA ANALYSIS PROCEDURE:Data will be collected and statistically analyzed using the SPSS software version 29. Mean and standard deviation will be calculated for quantitative variables like age, etiology, associated fractures, clinical and radiological parameters. Frequency and percentage will be measured for qualitative measures like gender, site. Efficacy between both groups will be compared by t-test and a P value of less than or equal to 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Muhammad Waheed Tahir, BDS, FCPS OMFS
  • Phone Number: 092-3127307601
  • Email: mwaheed76@gmail.com

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Institute of Medical Sciences Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1.All dentate and partially dentate patients with unilateral mandibular angle fracture.
  • 2. Both isolated mandibular angle fractures and mandibular angle fractures associated with other facial fractures will be included

Exclusion Criteria:

  • 1.Comminuted mandibular angle fractures.
  • 2.Edentulous patients.
  • 3. Gross external laceration in submandibular region.
  • 4.Presence of local bone pathology alongwith fracture will be excluded from study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A will undergo transoral technique for mandibular angle fracture reduction
In Group A transoral approach inferior alveolar nerve block and buccal nerve block will be given by 2% xylocaine with 1:100000 adrenaline. Incision will be made with surgical blade no 15 from gingival crevices of molars to ascending ramus. Fracture segments will be reduced alongwith MMF. A 5-hole 2mm miniplate with 2 holes anterior and 2 holes posterior to fracture line will be screwed to external oblique ridge and MMF will be removed and incision line will be closed
Procedure: Transoral technique for mandibular angle fracture reduction
In transoral technique approach inferior alveolar nerve block and buccal nerve block will be given by 2% xylocaine with 1:100000 adrenaline. Incision will be made with surgical blade no 15 from gingival crevices of molars to ascending ramus. Fracture segments will be reduced alongwith MMF. A 5-hole 2mm miniplate with 2 holes anterior and 2 holes posterior to fracture line will be screwed to external oblique ridge and MMF will be removed and incision line will be closed.
Experimental: Group B will undergo transbuccal technique for mandibular angle fracture reduction
In Group B tranbuccal technique approach inferior alveolar nerve block and buccal nerve block will be given by 2% xylocaine with 1:100000 adrenaline. Incision will be made with surgical blade no 15 from gingival crevices of molars to ascending ramus. Fracture segments will be reduced alongwith MMF after which extraorally a stab incision will be made with scalpel blade parallel to relaxed resting skin tension lines through which the cannula with a trocar will be inserted through facial tissue down to bone. Transbuccal instrument system will cionsist of transbuccal guide, mountable retractor, drill sleeve, drill guide, and 2mm drill bit. A 2mm titanium miniplate will be placed along buccal cortex and screwed through trocar system. MMF will be removed and incision line closed
Procedure: Transbuccal technique for mandibular angle fracture reduction
In transbuccal technique inferior alveolar nerve block and buccal nerve block will be given by 2% xylocaine with 1:100000 adrenaline. Incision will be made with surgical blade no 15 from gingival crevices of molars to ascending ramus. Fracture segments will be reduced alongwith MMF. extraorally a stab incision will be made with scalpel blade parallel to relaxed resting skin tension lines through which the cannula with a trocar will be inserted through facial tissue down to bone. Transbuccal instrument system will cionsist of transbuccal guide, mountable retractor, drill sleeve, drill guide, and 2mm drill bit. A 2mm titanium miniplate will be placed along buccal cortex and screwed through trocar system. MMF will be removed and incision line closed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of mouth opening
Time Frame: 1 week, 1 month, 3 month
Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
1 week, 1 month, 3 month
MEAN OF GAP BETWEEN FRACTURE SEGMENTS
Time Frame: 1 week, 1 month, 3 month
Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
1 week, 1 month, 3 month
MEAN OF DISPLACEMENT OF FRACTURE SEGMENTS:
Time Frame: 1 week, 1 month, 3 month
Presence of step between distal and proximal segments in vertical plane at the lower border on OPG.
1 week, 1 month, 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 29, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1313-5995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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