Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06622642
Enrollment
68
Registered
2024-10-02
Start date
2024-12-01
Completion date
2025-06-01
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Angle Fracture, Surgical Approach & Incisions

Keywords

Mandible trauma, Mandible angle fracture, Intraoral approach, Transbuccal approach, champy's prinicple of plating

Brief summary

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

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.

Interventions

PROCEDURETransoral 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.

PROCEDURETransbuccal 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

Sponsors

Services Institute of Medical Sciences, Pakistan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean of mouth opening1 week, 1 month, 3 monthMouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
MEAN OF GAP BETWEEN FRACTURE SEGMENTS1 week, 1 month, 3 monthGap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
MEAN OF DISPLACEMENT OF FRACTURE SEGMENTS:1 week, 1 month, 3 monthPresence of step between distal and proximal segments in vertical plane at the lower border on OPG.

Countries

Pakistan

Contacts

Primary ContactShanza Rehman, BDS
shanzarehman175@gmail.com092-3368821994
Backup ContactMuhammad Waheed Tahir, BDS, FCPS OMFS
mwaheed76@gmail.com092-3127307601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026