Clinical trial NCT06622642: Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture
Official title: Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture in Terms of Mouth Opening and Radiographic Gap and Displacement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandibular Angle Fracture
Surgical Approach &amp; Incisions
Keywords: Mandible trauma
Mandible angle fracture
Intraoral approach
Transbuccal approach
champy&#39;s prinicple of plating
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 68
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean of mouth opening
timeFrame: 1 week, 1 month, 3 month
measure: MEAN OF GAP BETWEEN FRACTURE SEGMENTS
timeFrame: 1 week, 1 month, 3 month
measure: MEAN OF DISPLACEMENT OF FRACTURE SEGMENTS:
timeFrame: 1 week, 1 month, 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences Lahore
state: Punjab
Study officials:
References:
citation: 9. Hidayatullah SK, Saifullah SK. Outcome of Transbuccal and Transoral Technique in Open Reduction and Internal Fixation of Mandibular Angle Fractures. Pak J Med Health Sci. 2022 Jul 30;16(07):85-85
citation: 8. Elsayed SA, Reda HM, Awadd MM, Mourad SI, Shokeir HM, Elsayed EH, Al-Moraissi. Transbuccal vs intraoral approach using an angulated screwdriver in fixation of a mandibular angle fracture. Open Dent J. 2022 Aug 16(1):1-7
citation: 7. Gupta S, Pandilwar P, Yerragudi N, Chawla JG, Redij S, Kumbhare S. Fixation of mandibular angle fracture by transoral approach versus transbuccal approach a clinical .and radiographic study.Asian J Contemp Dent Sci.2021 March 1(1):04-07
citation: 6. Asim M,Muddassar M,Qureshi IS,Rana ZA, Hoti KK. Comparison of intraoral external oblique ridge fixation and transbuccal lateral cortical plate fixation for mandibular angle fracture-A randomized control trial. Health Sci J. 2020;14(3):716.
citation: Sehrawat K, Malik B, Vallabha HV, Vaishnavi AB, Pendyala SK, Ibrahim M, Binyahya FA. A Comparative Evaluation of Transbuccal versus Transoral Approach for the Management of Mandibular Angle Fractures: A Prospective, Clinical, and Radiographic Study. J Pharm Bioallied Sci. 2021 Nov;13(Suppl 2):S1295-S1299. doi: 10.4103/jpbs.jpbs_112_21. Epub 2021 Nov 10.
citation: Bhardwaj B, Singh J, Mahajan S. Transbuccal Approach in Management of Mandible Angle Fracture. Indian J Otolaryngol Head Neck Surg. 2020 Dec;72(4):457-462. doi: 10.1007/s12070-020-01904-y. Epub 2020 Jun 23.
citation: Krishnan Kutty D, Hallur N, Siddiqa A, Zakaullah S, Kothari C. Management of Sub-Condylar and Angle of Mandible Fracture by a Trans-Buccal Trocar Along With an Intra-Oral Approach. Indian J Otolaryngol Head Neck Surg. 2020 Dec;72(4):538-544. doi: 10.1007/s12070-020-02058-7. Epub 2020 Aug 20.
citation: 2. Khokhar M, Sadhwan BS, Tailor SS. Comparison of intra-oral and extra-oral approaches in mandibular angle fractures. Nat J Clinic Orthop 2022; 6(3): 01-03
citation: Pavithra SK, Vivek N, Saravanan C, Karthik R, Prashanthi G, Scott C. Comparison of Conventional Versus Right Angled Fixation Technique in Management of Mandibular Angle Fractures - A Prospective Randomized Clinical Study. J Oral Maxillofac Surg. 2023 Aug;81(8):1001-1010. doi: 10.1016/j.joms.2023.04.005. Epub 2023 Apr 20.