| CTRI Number |
CTRI/2025/10/095787 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing how often patients experience numbness in the lower lip and chin after two different types of lower jaw surgery in the traditional method versus a newer less invasive technique. |
|
Scientific Title of Study
|
Comparative evaluation of inferior alveolar nerve dermatome paresthesia in conventional bilateral sagittal split osteotomy versus low and short medial cut osteotomy A single blinded Randomised Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandana Vinod |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
First floor,Department of Oral and Maxillofacial Surgery,Centre for Dental Education and Research,All India Institute of Medical Sciences,New Delhi 11002
New Delhi
DELHI
110029
India |
| Phone |
9605892492 |
| Fax |
|
| Email |
nanadana.r.vinod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krushna Bhatt |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
First floor,Department of Oral and Maxillofacial Surgery,Centre for Dental Education and Research,All India Institute of Medical Sciences,New Delhi 110029
First floor,Department of Oral and Maxillofacial Surgery,Centre for Dental Education and Research,All India Institute of Medical Sciences,New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9899325168 |
| Fax |
|
| Email |
bhatt_krushna@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandana Vinod |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
First floor,Department of Oral and Maxillofacial Surgery,Centre for Dental Education and Research,All India Institute of Medical Sciences,New Delhi 11002
DELHI
110029
India |
| Phone |
9605892492 |
| Fax |
|
| Email |
nanadana.r.vinod@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Ansari Nagar,New Delhi,India-110029 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Nandana Vinod |
All India Institute of Medical Sciences,New Delhi |
First floor,Department of Oral and Maxillofacial Surgery,Centre for Dental Education and Research,All India Institute of Medical Sciences 110029
New Delhi
DELHI |
9605892492
nandana.r.vinod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AIIMS New Delhi Ethics Committee |
Submittted/Under Review |
| Institutional ethics committee,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M268||Other dentofacial anomalies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral sagittal split osteotomy with low and short medial cut osteotomy |
Comparative evaluation of inferior alveolar nerve dermatome paresthesia in bilateral sagittal split osteotomy versus low and short medial cut osteotomy for a follow-up period of 6 months |
| Comparator Agent |
Conventional bilateral sagittal split osteotomy |
Comparison of inferior alveolar nerve dermatome paresthesia in conventional bilateral sagittal split osteotomy versus low and short medial cut osteotomy for a follow-up period of 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in study
Patient giving informed consent |
|
| ExclusionCriteria |
| Details |
Patient not giving informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Inferior alveolar nerve dermatome paresthesia |
Inferior alveolar nerve dermatome paresthesia at immediate postop period,1 month,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Accuracy of movements achieved |
immediate postop and 6 months postoperatively |
| To assess frequency percentage of complication like bad split,lingual plate interferences,bleeding,duration |
intraoperatively |
| To assess fixation failure,wound dehiscence,surgical site infection,occurence of TMD/condylar instability,relapse |
7 days postoperatively,6 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
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
|
Comparative evaluation of inferior alveolar nerve dermatome paresthesia in conventional bilateral sagittal split osteotomy versus low and short medial cut osteotomy: A single blinded,Randomised Controlled Trial
This comparison focuses on the risk of inferior alveolar nerve (IAN) paresthesia after two types of mandibular surgery:
Conventional Bilateral Sagittal Split Osteotomy (BSSO)
Low and Short Medial Cut Osteotomy (a modified, less invasive version)
Modified BSSO techniques — like the short medial cut — tend to result in:
Lower risk of nerve injury
Faster sensory recovery
Less long-term paresthesia
This is likely because they reduce nerve exposure and manipulation during surgery.
Conventional BSSO, while effective, maybe associated with:
Higher rates of IAN disturbance
Longer recovery times for sensation
Greater chance of lasting numbness or altered sensation
No exact randomized controlled trial (RCT) comparing these two techniques has been published yet. However, related studies suggest the modified approach is safer for nerve preservation. |