CTRI Number |
CTRI/2025/04/085422 [Registered on: 23/04/2025] Trial Registered Prospectively |
Last Modified On: |
22/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparision between 5 hole strut plate and 4 hole delta plate for treatment of fractures of the head of the lower jaw. |
Scientific Title of Study
|
3D Strut plate versus delta plate in management of mandibular condylar fracture- a prospective randomised clinicoradiographic comparative study |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ayushi Jha |
Designation |
PG Resident |
Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Address |
02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
Lucknow UTTAR PRADESH 226025 India |
Phone |
9643280799 |
Fax |
|
Email |
ayushi80799@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Gaurav Singh |
Designation |
Professor and Head |
Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Address |
02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
Lucknow UTTAR PRADESH 226025 India |
Phone |
9415086536 |
Fax |
|
Email |
dr.gaurav1502@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Gaurav Singh |
Designation |
Professor and Head |
Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Address |
02, Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences Chaudhary Vihar Utrathia Raebareily Road Lucknow 226025 Uttar Pradesh
Lucknow UTTAR PRADESH 226025 India |
Phone |
9415086536 |
Fax |
|
Email |
dr.gaurav1502@gmail.com |
|
Source of Monetary or Material Support
|
Department of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow, Uttar Pradesh, India
Pin code- 226025 |
|
Primary Sponsor
|
Name |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences |
Address |
Raebareily road Lucknow- 226025 |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Ayushi Jha |
Out Patient Department of Oral and Maxillofacial Surgery |
Department of Oral and Maxillofacial Surgery Sardar Patel Post graduate institute of Dental and Medical Sciences, Lucknow Lucknow UTTAR PRADESH |
9643280799
ayushi80799@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Intitutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
3D Strut Plate |
Using a conventional retromandibular incision, the fracture site is exposed. The Langenbeck retractor, which is positioned at the sigmoid notch, will be used for the reduction. Next, a 2 mm system 5-hole Strut subcondylar plate made of titanium will be positioned at the fractured site, with its short arm situated slightly below the sigmoid notch and its long arm parallel to the posterior border of the ramus of the mandible. The plate will be secured in place by five 8 mm titanium screws. After fixing the plates, Maxillomandibular Fixation will be released and occlusion will be checked. The extraoral incision will be sealed with 4-0 prolene on the skin and 3-0 vicryl in the deep layers. Along with Maxillo-Mandibular Fixation training elastics will also be placed on all the patients since second post-operative day for 2 weeks. Patients will be evaluated immediately following surgery, as well as 1, 2, 3, and 6 weeks later. 2 weeks following surgery, Maxillo Mandibular Fixation will be released, and following the fourth post-operative week, arch bars will be taken out. All the patients to be given a high dose of antibiotics and analgesics post-operatively. Patients will receive strict instructions regarding oral hygiene. |
Comparator Agent |
Delta Plate |
Using a conventional retromandibular incision, the fracture site is exposed. The Langenbeck retractor, which is positioned at the sigmoid notch, will be used for the reduction. The fracture site will have a delta plate placement, with the base of the plate pointing in the direction of the angle of mandible. The plate will be secured in place by four 8 mm titanium screws. After fixing the plates, Maxillomandibular Fixation will be released and occlusion will be checked. The extraoral incision will be sealed with 4-0 prolene on the skin and 3-0 vicryl in the deep layers. Along with Maxillo-mandibular Fixation training elastics will also be placed on all the patients since second post-operative day for 2 weeks. Patients will be evaluated immediately following surgery, as well as 1, 2, 3, and 6 weeks later. 2 weeks following surgery, Maxillo-Mandibular Fixation will be released, and following the fourth post-operative week, arch bars will be taken out. All the patients to be given a high dose of antibiotics and analgesics post-operatively. Patients will receive strict instructions regarding oral hygiene. |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Condylar fractures with or without occlusal discrepancy.
Displaced and undisplaced both types of condylar fracture.
American Society of Anaesthesiologist Classification (ASA) I and II patient.
Condylar fractures: unilateral or bilateral
|
|
ExclusionCriteria |
Details |
Edentulous mandible fracture.
Pre-existing discrepancies in skeleton
Pathological problems that were present in the temporomandibular joints before.
Condylar head fracture
Condylar fracture associated with any other mid-face fracture.
Severely comminuted along with infected fracture.
Patients who are not fit to undergo procedure under general anaesthesia.
Previous history of irradiation of head and neck area |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Primary Outcome is to compare the clinical and radiological outcomes of 3D strut plate with delta plate in the treatment for condylar fractures of mandible and to asses occlusal discrepancy, Maximum interincisal opening, bite force, fracture stability, restoration of ramus height and post operative complications |
The estimated time may range upto 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary outcome is to assess pain, facial nerve funtion, post operative complications |
The estimated time may range upto 6 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
03/05/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The
data for this study will be collected from the patients with fractures of
condyle of mandible who visit the Out Patient Department (OPD) of Oral and Maxillofacial Surgery, Sardar Patel Post Graduate Institute of Dental and Medical Sciences,
and Dr. O.P. Chaudhary Hospital and Research Centre, Lucknow, will be the
subjects of the study. Each
patient will be asked for written informed consent after being fully informed
about the procedure’s nature, expected results, and potential side effects.
Patient will be selected irrespective of caste, creed, sex,
religion or socio-economic status. Each
patient will be randomly allocated to group A and group B using lottery
method. Surgical procedure will be performed under General Anaesthesia.
Patient will be laid on the operating table and Intravenous line will be
secured. Anaesthesia will be induced by Propofol and maintained by Halothane
and O2 + N2O. Nasotracheal intubation will be done.
Surgical site preparation, draping, and maxillomandibular fixation will be
done. Local infiltration will be given. Following the preparation of the
surgical sterile field, surface markings will be made and the zygomatic arch,
mandibular condyle, and ramus up to the angle will be identified. After that,
the fracture end will be described. There will be a conventional
retromandibular incision made. The periosteum is raised and the fracture
is located once the surface of the bone is reached. The Langenbeck retractor,
which is positioned at the sigmoid notch, will be used for the reduction. Next,
a 2 mm system 5-hole Strut subcondylar plate made of titanium will be
positioned at the fractured site, with its short arm situated slightly below
the sigmoid notch and its long arm parallel to the ramus’s posterior border.
The plate will be secured in place by five 8 mm titanium screws, or the
fracture site will have a delta plate placement using four 8mm screws, with the
base of the plate pointing in the mandibular angle’s direction. After fixing
the plates, Maxillo-mandibular Fixation will be released and occlusion will be
checked. The extraoral incision will be sealed with 4-0 Prolene on the skin and
3-0 Vicryl in the deep layers. Along with Maxillo-mandibular Fixation training
elastics will also be placed on all the patients since second post-operative
day for 2 weeks. Patients will be evaluated immediately following surgery, as
well as one, two, three, and six weeks later. Two weeks following surgery, Maxillo-mandibular
Fixation will be released, and following the fourth post-operative week, arch
bars will be taken out. All the patients to be given a high dose of antibiotics
and analgesics post-operatively. Patients will receive strict instructions
regarding oral hygiene. |