A comparison between a new interdental wiring technique with currently used technique in the treatment of facial jaw fractures

Not yet recruiting

Conditions: Maxillofacial trauma patients who are otherwise healthy and not medically compromised

Registration Number: CTRI/2017/12/010760

Lead Sponsor: Dr Abdul Ahad G Khan

Brief Summary: **Introduction**

Intermaxillary fixation (IMF) is used in thetreatment of jaw fractures since times immemorial. It is necessary to orientthe jaw bones into satisfactory dental occlusion before fixation of jawfractures. However the contemporary techniques used for IMF are tedious, timeconsuming, traumatic for the patient as well as the operator, difficult fororal hygiene maintenance, with inherent risk of transmission of blood-bornediseases and increased duration ofsurgical anesthesia. So, this study was designed in which a novel technique ofIMF is compared with the contemporary technique for IMF, Ivy eyelet IMF, toevaluate and compare the efficacy and inherent associated complications.

**Aims& Objectives**

The aim of the study is to compare the new intermaxillaryfixation wiring technique with eyelet wiring for intermaxillary fixation of jawfractures. The objectives will include comparison based on

1.      Timeduration required for application of IMF

2.      Stabilityof IMF over the treatment span and

3.      Incidenceof glove perforation.

Materials & Methods

A sample of 80 subjects from amongst the maxillofacial traumapatients referred to the OPD/IPD of Deptof Oral and Maxillofacial Surgery, GDCH Aurangabad fulfilling the specifiedinclusion criteria will be randomly divided into test and control group andwill be blinded off the methodology used. Inter Maxillary Fixation will be doneby 2 or more different surgeons with comparable surgical/wiring skills underlocal anesthesia/GA. IMF will be placedfor 4-6 weeks depending on the facts of the case, with weekly follow-up .

The observations will be made as follows:

1.      The time taken for wiring is fromthe application of first wire till the completion of IMF and will be noted downin minutes.

2.      Stability of IMF will be assessed bymaintenance of IMF wires as otherwise there will be loosening of the IMF wires.

3.      Incidence of Glove perforation willbe assessed by inflating the glove post-wiring by water/saline to look forleakages.

4.      Digital OPG will be taken at 4months and 6 months to assess thehealing of the fracture as evidenced by disappearance/reduction in radiolucencyof the fracture line.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1.Minimally displaced jaw fractures either maxilla and/or mandible screened clinically and confirmed radiographically by means of a digital OPG 2.Occlusion should be minimally disturbed/deranged 3.Favourable fractures 4.Multiple fractures with at least 3-4 teeth firmly fixed to basal bone in all fragments 5.Undisplaced Condylar fractures in which occlusion is minimally deranged that can be manipulated into satisfactory occlusion under local anesthesia manually 6.Zygomatico-maxillary complex fractures not requiring open reduction/ fixation 7.Jaw fractures with good proximal contacts between the teeth 8.Healthy patients free from medical compromise such as diabetes, hypertension, B asthma, Epilepsy, drug allergies etc.

Exclusion Criteria

1.Unfavourable fractures 2.Fractures with grossly deranged occlusion 3.Mixed dentition period for need of good dento-alveolar support 4.Comminuted jaw fractures 5.Dento-alveolar fractures 6.Displaced condylar fractures requiring open reduction internal fixation 7.Partially/ totally edentulous jaw fractures 8.Jaw fractures with open proximal contacts between the teeth 9.Medical problems such as bronchial asthma, epilepsy that preclude IMF 10.Oral mucosal conditions that pose significant restrictions on operators maneuverability such as oral submucous fibrosis .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time duration required for application of IMF in minutes measured from the point in time when the first wire placement is started to the finished tucking of IMF wires interdentally	Measured at the time of intervention
To compare the new intermaxillary fixation wiring technique with eyelet wiring for intermaxillary fixation of jaw fractures based on:	Measured at the time of intervention

Secondary Outcome Measures

Name	Time	Method
1.Stability of IMF over the treatment span assessed by maintenance/ loosening of IMF wires	2.Incidence of glove perforation assessed by glove inflation by water post intervention

Trial Locations

Locations (1): Govt Dental College and Hospital, Aurangabad
🇮🇳
Aurangabad, MAHARASHTRA, India
Govt Dental College and Hospital, Aurangabad
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Abdul Ahad G Khan
Principal investigator
9552002731
drabdulahadkhan@gmail.com