| CTRI Number |
CTRI/2025/01/079219 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the Success rate and stability of Temporary Skeletal Anchorage devices A Randomized Controlled Trial |
|
Scientific Title of Study
|
Success Rate and Stability of Temporary Skeletal Anchorage Devices A Randomized 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 |
Dr Akansha Pandey |
| Designation |
Postgraduate student |
| Affiliation |
Banaras Hindu University |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,India, 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450003088 |
| Fax |
|
| Email |
waytoakansha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ajit Vikram Parihar |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,India, 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8004925688 |
| Fax |
|
| Email |
drajitparihar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akansha Pandey |
| Designation |
postgraduate student |
| Affiliation |
Banaras Hindu University |
| Address |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,India, 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450003088 |
| Fax |
|
| Email |
waytoakansha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India , 221005 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 Akansha Pandey |
Institute of medical sciences, Banaras hindu university |
Faculty of dental sciences, Institute of medical sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,India, 221005
Varanasi
UTTAR PRADESH |
9450003088
waytoakansha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VARANASI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insertion of temporary skeletal anchorage device. |
insertion of extra-alveolar mini-screw on left side |
| Intervention |
Insertion of temporary skeletal anchorage devices |
Insertion of extra-alveolar mini-screw on right side |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
33.00 Year(s) |
| Gender |
Both |
| Details |
Fully Erupted permanent dentition
15 to 33 years of age.
Requiring Extra alveolar bone screw as a method of anchorage for retraction of teeth.
|
|
| ExclusionCriteria |
| Details |
Systemic diseases or syndromes
Long-term anti-inflammatory medication
Extraction or missing permanent teeth
History of previous orthodontic treatment
Parafunctional habits
Grossly decayed teeth
• Any cases of facial asymmetry
• Temporomandibular dysfunction
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical stability of temporary skeletal anchorage devices |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Success rate of temporary skeletal anchorage devices |
8 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/02/2025 |
| 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="1"
Months="0"
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
|
1. To evaluate the Success rate and stability of Temporary Skeletal Anchorage Devices used in Orthodontics. 2. To assess other factors such as 1. Age 2. Gender 3. Side of Implant 4. Facial Growth Pattern 5. Primary stability of mini-screws 6. Implant site and Insertion Angle 7. Insertion and Removal torque values of mini-screws 8. Oral hygiene of the patient 9. Mobility of the implant 10. Soft tissue thickness 11. Cortical Bone Thickness 12. Inflammation and pain 13. Loading force. 3. To compare the Success Rate in Males and Females based on various parameters. |