ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624001487505

Ethics application status

Approved

Date submitted

3/10/2024

Date registered

20/12/2024

Date last updated

20/12/2024

Date data sharing statement initially provided

20/12/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The functional outcomes of adult mandibular condylar fractures with open surgical techniques versus closed reduction modalities-A single blinded randomised control trial

Scientific title

The functional outcomes of adult mandibular condylar fractures with open surgical techniques versus closed reduction modalities-A single blinded randomised control trial

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

treatment of adult mandibular condylar fractures

Condition category

Condition code

Injuries and Accidents

Fractures

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The open reduction group’s treatment will be performed through a 3-cm preauricular incision or hind’s approach. For preauricular incision dissection proceeded in the space between ear cartilage and superficial temporal vessels to safely approach the zygomatic arch until the anterior border of the zygomatic eminence is met. The joint capsule will be opened, and medial displaced fracture segment will be reduced back to the glenoid fossa with the preservation of the attachment of lateral pterygoid muscle and the cartilaginous surface.
For hinds approach a vertical incision will be placed through the skin and subcutaneous tissue extending 0.5 cm below the ear lobe towards the angle of the mandible and 1cm posterior and parallel to the posterior border of the mandible. We will go through either trans parotid or retro parotid approach. After subcutaneous dissection the superficial musculoaponeurotic system (SMAS) layer will be incised vertically. Blunt dissection done either within the parotid gland or behind the gland parallel to the facial nerve will be done. Upon reaching the posterior border pterygomasseteric sling will be incised. Mandible will be exposed. If there is sufficient space for placement of a plating system, we will use a semirigid fixation with 2 titanium miniplate (Shangai Haqsun medical instruments) for condylar head fractures one along the posterior border and another anterior medially placed . The occlusion and Temperomandibular joint mobility will be evaluated. Displaced discs will be reduced if found, and finally the joint capsule will be repaired. All concomitant mandible and maxillary fractures will also be treated by open reduction and rigid fixation by rigid plating systems at the same time. After the operation, all patients will receive intermaxillary fixation (IMF) via eyelet wiring to maintain occlusion. The period of IMF ranged from 2 to 6 weeks according to the patients’ occlusion condition. All patients will adopt a liquid diet for 1 week, followed by a soft diet in subsequent month after the operation.
Both surgical procedures will take up to 3 hours. The surgery will be performed by one maxillofacial surgeon. After surgery the record of the surgery/ procedure will be made with patient record ID in hospital management information system (HMIS) for postop follow-up. There will be no follow-up surgeries. The open surgical group will receive post op physiotherapy with wooden spatulas at 4 weeks postoperatively. the postoperative physiotherapy will involve wooden spatula sticks kept between upper and lower teeth for 10 mins repeated 3 to 4 times a day increasing one spatula per day.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

For the closed reduction group, the treatment was IMF after manual reduction, without the intervention of TMJ joint space. After the operation, all patients will receive IMF via eyelet wiring to maintain occlusion. The period of intermittent IMF will range from 4 to 8 weeks according to the patients’ occlusion condition. Intensive physiotherapy will be initiated postoperatively with routine dental visits to our clinic to resume early mouth opening with wooden spatulas 4 times a day increasing one spatula per day. The patient will be educated about the physiotherapy by physiotherapist once and will continue doing at home with the help of attendant. All patients will adopt a liquid diet for 1 week, followed by a soft diet in subsequent month after the operation.

Control group

Active

Outcomes

Primary outcome [1]

interincisal mouth opening

Timepoint [1]

at 6 weeks and 6 months time post operatively

Primary outcome [2]

occlusion

Timepoint [2]

at 6 weeks and 6 months time post operatively

Secondary outcome [1]

pain

Timepoint [1]

pain recorded at 6 weeks and 6 months interval postoperatively

Eligibility

Key inclusion criteria

Adult population of age 18 years and above of all genders, ethnicities and geographical areas with traumatic bone condylar fracture will be included in this trial

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with firearm injury of the condylar region, underlying pathological bone diseases and recurrent fractures of condyles will not be included in this trial.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

group assignments will be based on sequentially numbered opaque sealed envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

There will be two groups each having 17 patients, randomly allocated using random sequence generator.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Frequencies and percentages will be calculated for categorical data. For scale data calculated by mean SD, scale data will be analysed by using T -TEST by comparing mean differences. For secondary outcome we will analyse using chi-square test and fisher test if required. Probability value will be considered significant at < 0.05. Subgroup analysis will be done where needed as for age, gender, level and type of condylar bone fractures ( unilateral and bilateral , low high condylar neck fractures).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/12/2024

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

KPK

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lady Reading Hospital Medical Teaching Institute Peshawar

Address [1]

Country [1]

Pakistan

Funding source category [2]

Hospital

Name [2]

Lady Reading Hospital , Medical teaching institute Peshawar

Address [2]

Country [2]

Pakistan

Primary sponsor type

Hospital

Name

Sehath Sahuluth Card, Lady Reading Hospital Medical Teaching Institute Peshawar

Address

Country

Pakistan

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Lady Reading Hospital, Medical Teaching Institute . Institutional review board (IRB)

Ethics committee address [1]

research new medsurg building 4th floor Seokarno chowk Lady Reading Hospital Peshawar Cantt ,25000,KPK

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

07/10/2024

Approval date [1]

06/11/2024

Ethics approval number [1]

Ethics committee name [2]

Lady Reading Hospital, Medical Teaching Institute . Institutional review board (IRB)

Ethics committee address [2]

research@lrh.edu.pk

Ethics committee country [2]

Pakistan

Date submitted for ethics approval [2]

07/10/2024

Approval date [2]

Ethics approval number [2]

Summary

Brief summary

There are two treatment options for management of condylar fracture i.e. open surgery and closed treatment. Traditionally the conservative management with or without maxillomandibular fixation (MMF) has been the recommended course of care.
There are better functional outcomes with surgical techniques than closed methods.  Due to possible complications with open surgical methods this option is reserved for severe trauma cases for better functional outcomes.
This clinical trial aims to address significant gaps in the current understanding of treatment options for mandibular condylar fractures, ultimately enhancing patient care and outcomes in oral and maxillofacial surgery.
The main objective of this randomized control trial is to compare the different functional outcomes in the form of mouth opening, occlusion and pain by open surgical techniques versus closed reduction techniques with or without MMF of condylar fractures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Sana Wazir

Address

Lady Reading Hospital, Soekarno Road,PTCL Colony,Peshawar, Khyber Pakhthunakhwa 25000

Country

Pakistan

Phone

+92919211430

Fax

sana.wazir@lrh.edu.pk

Contact person for public queries

Name

Sana Wazir

Address

Lady Reading Hospital Peshawar Soekarno Road,PTCL Colony,Peshawar, Khyber Pakhthunakhwa 25000

Country

Pakistan

Phone

+92919211430

Fax

sana.wazir@lrh.edu.pk

Contact person for scientific queries

Name

Sana Wazir

Address

Lady Reading Hospital Peshawar Soekarno Road,PTCL Colony,Peshawar, Khyber Pakhthunakhwa 25000

Country

Pakistan

Phone

+92919211430

Fax

sana.wazir@lrh.edu.pk

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24242	Informed consent form					388466-(Uploaded-03-10-2024-20-08-20)-Consent _1 (1).pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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