| CTRI Number |
CTRI/2025/06/089552 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if the profile of a patient improves with use of mini-implants during braces treatment in adults |
|
Scientific Title of Study
|
Efficacy of mandibular mini-implants in improving vertical control during maxillary anterior teeth retraction with mini-implant anchorage in adult patients -A randomized control |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrIsha Shrikant Joshi |
| Designation |
Junior Resident |
| Affiliation |
Dr.D.Y Patil Dental College and Hosptial ,Pimpri ,Pune |
| Address |
Shree Samarth Apartment opposite shankar Mahadevan academy Behind vedvihar left bhusari colony Kothrud
Pune
MAHARASHTRA
411038
India |
| Phone |
7798520230 |
| Fax |
|
| Email |
joshiisha248@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajaganesh Gautam |
| Designation |
Head of Department and Professor |
| Affiliation |
Dr.D.Y Patil Dental College and Hosptial ,Pimpri ,Pune |
| Address |
Dr.D.Y.Patil Dental College and Hospital ,Santa-Tukaram Nagar ,pimpri ,Pune
MAHARASHTRA
411018
India |
| Phone |
9890389945 |
| Fax |
|
| Email |
rajaganesh.gautam@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrIsha Shrikant Joshi |
| Designation |
Junior Resident |
| Affiliation |
Dr.D.Y Patil Dental College and Hosptial ,Pimpri ,Pune |
| Address |
Shree Samarth Apartment opposite shankar Mahadevan academy Behind vedvihar left bhusari colony Kothrud
MAHARASHTRA
411038
India |
| Phone |
7798520230 |
| Fax |
|
| Email |
joshiisha248@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Isha Shrikant Joshi |
| Address |
Dr.D.Y.Patil Dental college and hospital ,Santa-Tukaram Nagar ,Pimri,Pune -411018 |
| Type of Sponsor |
Private medical college |
|
|
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 Isha Shrikant Joshi |
Dr.D.Y.Patil Dental College And Hospital ,Pimpri ,Pune |
Santatukaram Nagar ,Pimri,Pune .Department of Orthodontics and Dentofacial Orthopedics ,Department number 3.
Pune
MAHARASHTRA |
7798520230
joshiisha248@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee – Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune – 411018. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q188||Other specified congenital malformations of face and neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORTHODONTIC MINI SCREW IMPLNATS |
Placement of mini-implants (temporary anchorage devices) in both the maxilla and the mandible to assist in vertical control and retraction of maxillary anterior teeth during fixed orthodontic treatment in adult patients in the intervention group Mini-implants will be inserted interradicularly in the posterior region of the mandible and maxilla. Force application will be standardized and monitored during treatment . These will be placed only until the extraction space is closed that is a duration of 1 -1.5 year |
| Comparator Agent |
ORTHODONTIC MNI IMPLANTS |
Placement if mini-implants in just the maxilla for retraction of anterior teeth . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring extraction of four pre-molars
2. Adult Patients (Above 18 years)
3. ANB angle greater than 4 degree
|
|
| ExclusionCriteria |
| Details |
1. Patients with syndromes , craniofacial anomalies,systemic diseases .
2. Patients indicated for orthognathic surgery .
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the amount of vertical control of mandibular molar and thereby mandibular rotation between the two groups using cephalometric analysis before and after retraction. |
T1: At baseline, before initiation of anterior retraction
T2: At the end of space closure, approximately 7-8 months after T1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mandibular molar supra-eruption: Measured via cephalometric distance from molars to mandibular plane at baseline & post space closure (4–6 months).
Chin projection: Change in soft tissue pogonion to E-line, assessed via cephalograms at baseline & after space closure.
Anchorage loss: Mesial movement of maxillary molars evaluated using cephalometric landmarks at baseline & after space closure.
|
Mandibular molar supra-eruption – Baseline & after space closure (approx. 4–6 months)
Chin projection – Baseline & after space closure
Anchorage loss – Baseline & after space closure
|
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
09/07/2025 |
| 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="2"
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
|
This clinical study is designed to evaluate whether placing small screw-like devices (called mini-implants) in both the upper and lower jaws can help improve tooth movement and facial balance during braces treatment in adults. In certain orthodontic cases, especially in adults with a long face or vertical growth pattern, it is important to control unwanted upward movement (eruption) of lower back teeth during the treatment. If this eruption happens, it can interfere with efforts to improve facial profile and chin projection. Participants in this study will be adults who need upper front teeth retracted as part of their braces treatment. They will be randomly divided into two groups. One group will receive mini-implants only in the upper jaw, while the other group will receive them in both upper and lower jaws. The aim is to compare the effects of these two approaches in terms of controlling vertical tooth movement and improving overall facial appearance. X-rays will be taken before and after the treatment to measure changes in tooth position, jaw rotation, and chin projection. The expected outcome is that the group receiving both upper and lower jaw mini-implants will show better control over vertical changes and improved facial profile. This research could help develop better treatment guidelines for adult patients with similar orthodontic needs.
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