Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622642
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Efficacy of Transoral Versus Transbuccal Technique for Fixation of Mandibular Angle Fracture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 FRACTUREFracture line in area bound from the anterior border of the masetterdistal 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 SETTINGOral 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 populationrandom sample Population size1000000 Anticipated frequencyp50 Confidence limits12 absolute precision Design effect10 for random sample Sample size for 95 confidence level67 Sample size in each groupn34
SAMPLING TECHNIQUE Nonprobability purposive sampling technique
SAMPLE SELECTION
DATA COLLECTION PROCEDURE
METHODS OF DATA COLLECTIONPatients 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 ratioDiagnosis 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 1100000 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 TOOLSAll study variables will be assessed by single person at 1 week1 month and 3 months post opClinical parameters will be assessed through proformaquestionnaire Radiological parameters will be assessed through OPG PA mandible
DATA ANALYSIS PROCEDUREData 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 005 will be considered statistically significant
OPERATIONAL DEFINITIONS
MANDIBLE ANGLE FRACTUREFracture line in area bound from the anterior border of the masetterdistal 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 SETTINGOral 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 populationrandom sample Population size1000000 Anticipated frequencyp50 Confidence limits12 absolute precision Design effect10 for random sample Sample size for 95 confidence level67 Sample size in each groupn34
SAMPLING TECHNIQUE Nonprobability purposive sampling technique
SAMPLE SELECTION
DATA COLLECTION PROCEDURE
METHODS OF DATA COLLECTIONPatients 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 ratioDiagnosis 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 1100000 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 TOOLSAll study variables will be assessed by single person at 1 week1 month and 3 months post opClinical parameters will be assessed through proformaquestionnaire Radiological parameters will be assessed through OPG PA mandible
DATA ANALYSIS PROCEDUREData 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 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None