| CTRI Number |
CTRI/2025/07/091071 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Orthodontic Miniimplants Diameter on stability during complete retraction of Anterior teeth |
|
Scientific Title of Study
|
Effects of diameter of orthodontic miniimplants in their stability during enmasse Retraction of anterior teeth A prospective invivo study |
| 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 Vinayak Mattadabettu Ravishankar |
| Designation |
PG Student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
KVG Dental College and Hospital Sullia
Room No 7 Department of Orthodontics and Dentofacial Orthopaedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9141481637 |
| Fax |
|
| Email |
mrvinayak99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Revanth Soonthodu |
| Designation |
Reader |
| Affiliation |
KVG Dental College and Hospital |
| Address |
KVG Dental College and Hospital Sullia
Room No 7 Department of Orthodontics and Dentofacial Orthopaedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9900447440 |
| Fax |
|
| Email |
revanthss7@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Revanth Soonthodu |
| Designation |
Reader |
| Affiliation |
KVG Dental College and Hospital |
| Address |
KVG Dental College and Hospital Sullia
Room No 7 Department of Orthodontics and Dentofacial Orthopaedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9900447440 |
| Fax |
|
| Email |
revanthss7@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Vinayak Mattadabettu Ravishankar |
| Address |
KVG Dental College and Hospital Sullia
Room No 7 Department of Orthodontics and Dentofacial Orthopaedics
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vinayak Mattadabettu Ravishankar |
KVG Dental College and Hospital |
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka 574327 Dakshina Kannada KARNATAKA |
9141481637
mrvinayak99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
8x1.3 |
To assess the stability of 8mm x 1.3mm orthodontic mini-implants used asanchorage during enmasse retraction of anterior teeth
To assess if the diameter of orthodontic mini-implants will play a role in stability during enmasse retraction of anterior teeth.
Total Duration : 6 Months |
| Comparator Agent |
8x1.5 |
To assess the stability of 8mm x 1.5mm orthodontic mini-implants used as anchorage during enmasse retraction of anterior teeth.
To assess if the diameter of orthodontic mini-implants will play a role in stability during enmasse retraction of anterior teeth.
Total Duration : 6 Months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients requiring corrective orthodontic treatment
2.Patients aged 18 to 40 years
3.Patients requiring absolute anchorage with miniimplants
4.Tooth brushing right or left handed three times a day after each meal and no symptoms of any oral diseases
5.Only patients with planned extraction of 1st or 2nd premolar in the maxillary arch
6.Patients with good oral hygiene and good periodontal support. |
|
| ExclusionCriteria |
| Details |
1.Patients with poor oral hygiene
2.Patients not requiring absolute anchorage.
3.Non extraction treatment cases. |
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effects of diameter of orthodontic miniimplants in their stability during enmasse retraction of anterior teeth |
1,2,3,4,5,6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the stability of 8mm x 1.3mm orthodontic mini-implants used as anchorage during enmasse retraction of anterior teeth.
|
1,2,3,4,5,6 Months |
To assess the stability of 8mm x 1.5mm orthodontic mini-implants used as anchorage during enmasse retraction of anterior teeth
|
1,2,3,4,5,6 Months |
To compare the stability of 8mm x 1.3mm and 8mm x 1.5mm orthodontic mini-
implants used as anchorage during enmasse retraction of anterior teeth.
|
1,2,3,4,5,6 Months |
To assess if the diameter of orthodontic mini-implants will play a role in stability
during enmasse retraction of anterior teeth.
|
1,2,3,4,5,6 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="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
|
An important consideration to take into account during the planning of orthodontic treatment is anchorage control. Even with the usage of different methods to reinforce anchorage, desired outcomes are not always achieved. Conventional anchorage system predominantly involve the patient’s teeth or depend on their compliance, leading to uncontrollable and often undesirable movement. Several strategies have been developed to address this crucial issue in orthodontics. Skeletal anchoring techniques have gained significant among them. From the utilization of vitalinum screws to conventional osteointegrated implants for orthodontic anchorage, several methods have been used miniplates, onplates, palatal implants, miniimplants. These serve as valuable tools for achieving treatment goals. The key benefit of TADs is their provision of optimal biomechanics for both tooth movement and anchorage control, even in uncooperative patients. The other advantages of TADs are cost effectiveness, simplicity in their in their insertion and removal, and minimal occurence of complications during application. An early loss or loosening of a miniscrew is considered a failure that hampers therapeutic objectives Therefore many research focuses on examining variables influencing TADs stability during orthodontic tooth movement. Factors such as patient’s oral hygiene, oral and systemic conditions, smoking habits, surgical protocol (including implant location), loading technique (duration,force and direction) and type of TAD are among possible factors which might miniimplant failure. However conducting a compenhensive study of TAD stability is a difficult task therefore the need to establish patient group to ensure accurate findings and recommendations. Although small diameter miniimplants are convient to use as TADs in the maxilla and mandible they could compromise on primarily stabilty. To compensate for inadeqyuate intial stability in case of inferior bone quality and quantity large diameter diameter and long length implants may be used. Hence, this study aims to evaluate the impact of diameter of orthodontic miniimplants on their stablity during enmasse retraction of anterior teeth. |