Mandibular Angle FractureNCT06622642
Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture
A study testing Transoral technique for mandibular angle fracture reduction and Transbuccal technique for mandibular angle fracture reduction in people with Mandibular Angle Fracture and Surgical Approach &Amp; Incisions, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Mandibular Angle Fracture, Surgical Approach &Amp; Incisions
- What is being tested?
- Transoral technique for mandibular angle fracture reduction and Transbuccal technique for mandibular angle fracture reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences Lahore
Lahore, Punjab Province, 54000
About this study
Official title: 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
Read more
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
Read the 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.
- MOUTH OPENING: Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
- GAP BETWEEN FRACTURE SEGMENTS: Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
- 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.
- Being tested
- Transoral technique for mandibular angle fracture reduction, Transbuccal technique for mandibular angle fracture reduction
- Keywords
- Mandible trauma, Mandible angle fracture, Intraoral approach, Transbuccal approach, champy's prinicple of plating
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral technique for mandibular angle fracture reductionProcedure or surgery
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.
Transbuccal technique for mandibular angle fracture reductionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Transbuccal technique for mandibular angle fracture reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of mouth opening
Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mandibular Angle FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shanza Rehman, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622642
- Sponsor's protocol ID
- U1111-1313-5995
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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
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
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.
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.
PubMed 35017974Bhardwaj 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.
PubMed 33088775Krishnan 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.
PubMed 330887892. 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
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.
PubMed 37160255
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture in Terms of Mouth Opening and Radiographic Gap and Displacement
- ClinicalTrials.gov ID
- NCT06622642
- Acronym / sponsor ID
- U1111-1313-5995
- Keywords
- Mandible trauma, Mandible angle fracture, Intraoral approach, Transbuccal approach, champy's prinicple of plating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- MOUTH OPENING: Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.
- GAP BETWEEN FRACTURE SEGMENTS: Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A will undergo transoral technique for mandibular angle fracture reduction | Active comparator | Procedure: Transoral technique for mandibular angle fracture reductionIn 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 |
| Group B will undergo transbuccal technique for mandibular angle fracture reduction | Experimental | Procedure: Transbuccal technique for mandibular angle fracture reductionIn 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 |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral technique for mandibular angle fracture reductionIn 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. | Procedure or surgery | Group A will undergo transoral technique for mandibular angle fracture reduction |
| Transbuccal technique for mandibular angle fracture reductionIn 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 | Procedure or surgery | Group B will undergo transbuccal technique for mandibular angle fracture reduction |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background9. 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
- Background8. 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
- Background7. 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
- Background6. 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: PubMed 35017974Sehrawat 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.
- Background: PubMed 33088775Bhardwaj 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.
- Background: PubMed 33088789Krishnan 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.
- Background2. 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
- Results publication: PubMed 37160255Pavithra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral technique for mandibular angle fracture reduction and Transbuccal technique for mandibular angle fracture reduction in people with Mandibular Angle Fracture and Surgical Approach &Amp; Incisions, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanza Rehman, BDS (092-3368821994, shanzarehman175@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of mouth opening (time frame: 1 week, 1 month, 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622642, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.