| CTRI Number |
CTRI/2025/12/099820 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Fast Upper Front Teeth Move Up Using TADs, With or Without Micro-Osteoperforation |
|
Scientific Title of Study
|
Comparative evaluation of Deepbite correction utilizing Temporary Anchorage Devices (TADs) with and without Micro-osteoperforations- A Randomized 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 |
Ruchi Tiwari |
| Designation |
Postgraduate III Year Student in Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Rungta College of Dental Sciences and Research |
| Address |
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai
Durg
CHHATTISGARH
490023
India |
| Phone |
9329190823 |
| Fax |
|
| Email |
ruchitiwari1541998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaheen Hamdani |
| Designation |
Professor in Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Rungta College of Dental Sciences and Research |
| Address |
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai
Nehru-Nagar East, Bhilai
Durg
CHHATTISGARH
490023
India |
| Phone |
9993084442 |
| Fax |
|
| Email |
hamdanishaheen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Tiwari |
| Designation |
Postgraduate III Year Student in Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Rungta College of Dental Sciences and Research |
| Address |
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai
Durg
CHHATTISGARH
490023
India |
| Phone |
9329190823 |
| Fax |
|
| Email |
ruchitiwari1541998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai |
|
|
Primary Sponsor
|
| Name |
Rungta College of Dental Sciences and Research |
| Address |
R-2, Rungta College of Dental Sciences and Research,Kohka-kurud, Bhilai |
| Type of Sponsor |
Other [Private Dental college 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 |
| Ruchi Tiwari |
rungta college of dental sciences and research |
R-2,204, Department of orthodontics and Dentofacial orthopaedics, SRGI, kohka-kurud, Bhilai
Durg
CHHATTISGARH |
9329190823
ruchitiwari1541998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Orthodontic Patients with deepbite |
| Patients |
(1) ICD-10 Condition: R479||Unspecified speech disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TADs |
2 self-drilling TADs will be placed between maxillary lateral incisors and canine bilaterally.After 2 weeks, the upper incisors will be connected to TADs using elastomeric chains. |
| Comparator Agent |
TADs with Micro-osteoperforation |
2 self-drilling TADs will be placed between maxillary lateral incisors and canine bilaterally. After 2 weeks, the upper incisors will be connected to TADs using elastomeric chains.MOPs will target coronal and middle areas between central incisors, central and lateral incisors, as well as between lateral incisor and canine on both sides. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Deep overbite exceeding 50%.
Medically healthy condition.
Satisfactory oral hygiene and periodontal condition.
Complete set of permanent teeth present, excluding third molars. |
|
| ExclusionCriteria |
| Details |
Extreme skeletal malocclusion requiring orthodontic surgery.
Habit of smoking.
Patient with Bleeding Disorders.
Patient with prolonged medication affecting tooth movement. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To clinically evaluate and compare the rate of intrusion in maxillary anteriors during deep bite correction using TADs with and without Micro-osteoperforations.
To radiographically evaluate and compare the amount of intrusion in maxillary anteriors during deep bite correction using lateral cephalogram in both the groups. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pain perception of patients during maxillary anteriors intrusion in both the groups. |
3 Months |
|
|
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)
|
30/12/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This study compares how quickly the upper front teeth can be intruded during deep bite correction using TADs with and without Micro-osteoperforations (MOPs). Twenty patients aged 12–30 years will be treated with MBT fixed appliances and will have two TADs placed between the lateral incisor and canine on each side. In the MOP group, small bone perforations will be performed every three weeks for three months to speed up tooth movement. Tooth intrusion will be measured using lateral cephalograms taken at three stages: before treatment (T0), after initial alignment (T1), and after three months (T2). Cephalometric analysis will assess linear and angular changes in tooth position. Pain levels will also be recorded using a standardized questionnaire. The results will compare intrusion rates and patient discomfort between both groups. |