| CTRI Number |
CTRI/2024/07/070932 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between traditional method vs modified method of sagittal split surgery for forwardly or backward placed lower jaw |
|
Scientific Title of Study
|
A Comparative study of conventional Bilateral Sagittal Split Osteotomy vs Modified Sagittal Split Osteotomy requiring mandibular advancement or setback in skeletal malocclusion cases |
| 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 Harshni B |
| Designation |
Post graduate resident |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of Oral and Maxillofacial surgery, Sree Balaji dental college and hospital, Velachery main road, Narayanapuram , Chennai, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
9489338944 |
| Fax |
|
| Email |
drharshniomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saravanakumar B |
| Designation |
Professor |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of Oral and Maxillofacial surgery, Sree Balaji dental college and hospital, Velachery main road, Narayanapuram , Chennai, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
9444385846 |
| Fax |
|
| Email |
drsaranomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshni B |
| Designation |
Post graduate resident |
| Affiliation |
Sree Balaji dental college and hospital |
| Address |
Room no 03, Department of Oral and Maxillofacial surgery, Sree Balaji dental college and hospital, Velachery main road, Narayanapuram , Chennai, Tamil Nadu
TAMIL NADU
600100
India |
| Phone |
9489338944 |
| Fax |
|
| Email |
drharshniomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 03, Department of oral and maxillofacial surgery, Sree Balaji Dental College and Hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100 |
|
|
Primary Sponsor
|
| Name |
Dr Harshni B |
| Address |
Room no. 03, Department of Oral and maxillofacial surgery, Sree Balaji dental college and hospital, Velachery main road, Narayanapuram, Pallikaranai, Chennai, Tamil Nadu |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Harshni B |
Sree Balaji Dental College and Hospital |
Room no 03, Department of oral and maxillofacial surgery, Velachery main road, Narayanapuram, Pallikaranai, Chennai 600100
Chennai
TAMIL NADU |
9489338944
drharshniomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ( CLINICAL TRAIL) SREE BALAJI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q189||Congenital malformation of face and neck, unspecified, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral Sagittal Split Osteotomy |
This is a traditional method of surgical procedure required incase of skeletal malocclusion cases with prognathic or retrognathic mandible and the study will be completed in one and half years |
| Intervention |
Modified Sagittal Split Osteotomy |
This is a modified method of surgical procedure required incase of skeletal malocclusion cases with prognathic or retrognathic mandible and the study will be completed in one and half years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases with skeletal malocclusion requiring BSSO advancement or setback
2. Patients above 18 years of age and below 40 years of age
|
|
| ExclusionCriteria |
| Details |
1. History of Previous Orthognathic surgery
2. Immunocompromised patients.
3. Patients with other systemic conditions contraindicated for surgery.
4. Pregnancy or lactation
5. Severe TMJ disorder
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Stability of mandibular advancement and or setback
Complication rates
Functional outcome
Radiographic assessment
|
One week, three weeks and 6 weeks postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Balanced appearance of face
2. Improved breathing, chewing & swallowing functions
|
3 & 6 months postoperatively
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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="2"
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
|
Rationale behind the study is to evaluate the safety, and outcomes of these two surgical techniques. This study aim to determine which approach offers better results in terms of postoperative stability, functional outcomes and complications. Additionally, comparative studies help identify any advantages or disadvantages associated with each technique, aiding surgeons in making informed decisions about the most appropriate surgical approach for individual patients. |