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

NCT06622642 | Not Yet Recruiting DMC

• 1 other identifier: U1111-1313-5995
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Mandibular Angle Fracture; Surgical Approach & Incisions

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Mean of mouth opening

  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

  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:

  Presence of step between distal and proximal segments in vertical plane at the lower border on OPG.

  1 week, 1 month, 3 month

Study Arms (2)

Group A will undergo transoral technique for mandibular angle fracture reduction

ACTIVE COMPARATOR

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

Group B will undergo transbuccal technique for mandibular angle fracture reduction

EXPERIMENTAL

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

Interventions

Transoral technique for mandibular angle fracture reduction PROCEDURE

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.

Group A will undergo transoral technique for mandibular angle fracture reduction

Transbuccal technique for mandibular angle fracture reduction PROCEDURE

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

Group B will undergo transbuccal technique for mandibular angle fracture reduction

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35017974 BACKGROUND

• 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.

  PMID: 33088775 BACKGROUND

• 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.

  PMID: 33088789 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 37160255 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Shanza Rehman, BDS

CONTACT

092-3368821994; shanzarehman175@gmail.com

Muhammad Waheed Tahir, BDS, FCPS OMFS

CONTACT

092-3127307601; mwaheed76@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OMFS Resident

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)