| CTRI Number |
CTRI/2023/09/057905 [Registered on: 21/09/2023] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study in which we compare conventional vestibular incision to modified vestibular incision in symphysis and/ parasymphysis fracture |
|
Scientific Title of Study
|
A comparison between Modified vestibular incision and conventional vestibular incision in mandibular symphysis and/or parasymphysis fracture- An Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preethi sai G Shankar |
| Designation |
1st year Postgraduate |
| Affiliation |
Manipal college of dental sciences |
| Address |
Room no-4, Dept.of Oral and maxillofacial surgery, Manipal college of dental college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9686789305 |
| Fax |
|
| Email |
preethisai.g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adarsh Kudva |
| Designation |
Professor |
| Affiliation |
Manipal college of dental sciences |
| Address |
Room no-4, Dept.of Oral and maxillofacial surgery, Manipal college of dental college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886245099 |
| Fax |
|
| Email |
dradarshkudva@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupam Singh |
| Designation |
Assistant professor |
| Affiliation |
Manipal college of dental sciences |
| Address |
Room no-4, Dept.of Oral and maxillofacial surgery, Manipal college of dental college, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535619076 |
| Fax |
|
| Email |
anupamsingh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal college of dental sciences Manipal |
| Address |
Room No- 4, Dept. of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 Preethi sai G Shankar |
Manipal college of dental sciences, |
Dept of Oral and maxillofacial surgery, Manipal college of dental sciences, Manipal
Udupi
KARNATAKA |
9686789305
preethisai.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutuional ethics commitee -2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients with Symphysis and/or parasymphysis fractures of the mandible with or without associated with other facial fractures
b) Patients aged between 12 years to 80 years with ASA grading 1 to 3
c) Patients who will be managed surgically
d) Patients who are willing for the study
|
|
| ExclusionCriteria |
| Details |
a) Patients with infected fractures
b) Patients with tissue loss on the affected site
c)Patients who are not willing for the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of post operative function of mentalis muscle based on specific criteria
2. Total time taken for the surgery
3. Adequacy of the exposure
4. The clinical evaluation will help in determining need for further management of mentalis muscle dysfunction
|
1 week and 1 month post surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To help create a consensus among the clinicians on postoperative aesthetic & functional complications with respect to mentalis muscle dysfunction
2. Formulating guidelines for decision making in the incisions which would be appropriate in managing mandibular symphysis fractures
|
4weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
5.
Symphysis
fractures intraorally are approached by lower vestibular incisions which gives
advantageous access to the fracture. One of the important anatomical structures
encountered in the surgical field is the Mentalis muscle. It is important to
note that the Mentalis muscle, being the only elevator of lower lip needs to be
repositioned in a proper way to prevent untowardly aesthetic complications. In
one hand Conventional vestibular incisions require detachment of the mentalis
muscle for exposure and concerns arise over proper repositioning of muscle. On the
other hand, Modified vestibular incisions with the provision of adequate
exposure provide us the option of muscle sparring, thus aiding in uneventful
reposition and better functional and aesthetic outcome. Due to lack of specific
studies in literature, more research regarding the same is highly recommended. |