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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
 
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