| CTRI Number |
CTRI/2024/08/072635 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to compare the difference between two plates and one plate placement in orthognathic surgeries |
|
Scientific Title of Study
|
Comparison of Skeletal Stability between
Single-plate osteosynthesis and double-plate osteosynthesis in anterior mandibular osteotomies
-A randomised clinical 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 |
Raparthy Bhuvan Chandra |
| Designation |
PG Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Raghavendra Nager Colony, 1-35/1
Saveetha Dental College And Hospitals 162 Poonamallee High Road Velappanchavadi
Hyderabad
TELANGANA
500092
India |
| Phone |
9573856542 |
| Fax |
|
| Email |
raparthybhuvan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sneha pendem |
| Designation |
professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
saveetha dental college and hospitals
Thiruvallur
TAMIL NADU
500092
India |
| Phone |
9573856542 |
| Fax |
|
| Email |
drsneha_p@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Raparthy Bhuvan Chandra |
| Designation |
PG Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Raghavendra Nager Colony, 1-35/1
Saveetha Dental College And Hospitals 162 Poonamallee High Road Velappanchavadi
Hyderabad
TELANGANA
500092
India |
| Phone |
9573856542 |
| Fax |
|
| Email |
raparthybhuvan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental college and hospitals, saveetha institute of medical and technical sciences, saveetha university, 600054 |
|
|
Primary Sponsor
|
| Name |
saveetha dental college and hospitals |
| Address |
saveetha dental college and hospitals, SIMATS, Saveetha University, 600054 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhuvan Chandra |
saveetha dental college and hopitals |
Department of Oral and Maxillofacial Surgery, clinic no 20,Saveetha Dental College And Hospitals 162 Poonamallee High Road Velappanchavadi
Thiruvallur
TAMIL NADU |
09573856542
raparthybhuvan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instuitional human ethical comittee saveetha dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
double plate oteosynthesis. |
placement of two plates osteosynthesis in genioplasties and subapical osteotomies with follow up time of 6 months |
| Intervention |
single plate placement |
placement of single plate in genioplasties and lower subapical osteotomies with follow up time of 6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The study includes subjects aged 18 to 50, male or female, requiring anterior mandibular osteotomies (subapical osteotomies and genioplasties) for correction of skeletal mandibular deformities, and systematically healthy individuals. |
|
| ExclusionCriteria |
| Details |
Subjects with known systemic diseases, subjects who are mentally challenged, pregnant women, and lactating women. Patients undergoing genial corrections in transverse directions for facial asymmetry correction. Patients with cleft and craniofacial syndromes. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| skeletal stability with cephalometric landmarks, at immediate post op and 6 months postbop |
preop , immediate post op, 6 months post op
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
neuromuscular disturbances
ease of surgery
intraoperative time |
neuromuscular disturbances ( immediate post-op & 6 month post-op)
ease of surgeon |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
24/08/2024 |
| 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="1"
Months="6"
Days="20" |
|
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
|
The
present randomized control trial aims to fill this void in literature by comparing the quantitative treatment outcome
like skeletal stability achieved by using the traditional method of double
plate osteosynthesis and a relatively new technique of single plate
osteosynthesis in anterior mandibular osteotomies.
No
available literature reports a comparison between the aforementioned
techniques, making this trial a novel idea. |