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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-70
SponsorServices Institute of Medical Sciences, Pakistan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Transoral technique for mandibular angle fracture reduction

    Procedure/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 reduction

    Procedure/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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Group A will undergo transoral technique for mandibular angle fracture reductionActive comparator 1 intervention
Group B: Group B will undergo transbuccal technique for mandibular angle fracture reductionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean of mouth opening

Mouth opening will be defined as maximum interincisal distance measured in millimeters through ruler.

Time frame
1 week, 1 month, 3 month
2

MEAN OF GAP BETWEEN FRACTURE SEGMENTS

Gap between proximal and distal fracture lines measured in millimeters in OPG with ruler.

Time frame
1 week, 1 month, 3 month
3

MEAN OF DISPLACEMENT OF FRACTURE SEGMENTS:

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

Time frame
1 week, 1 month, 3 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: