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CTRI Number  CTRI/2025/10/095968 [Registered on: 13/10/2025] Trial Registered Prospectively
Last Modified On: 10/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating the Role of Denosumab in Orthodontic Anchorage Control: A Split-Mouth Randomized Controlled Trial 
Scientific Title of Study   Assessing the effect of denosumab on anchorage control- A Split mouth randomized control 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. Pravinkumar S Maroore 
Designation  Professor 
Affiliation  MIDSR Dental College Latur 
Address  DEPT. OF ORTHODONTICS, MIDSR DENTAL COLLEGE, VISHWANATHPURAM AMBAJOGAI ROAD, LATUR

Latur
MAHARASHTRA
413512
India 
Phone  7720821889  
Fax    
Email  drpravinkumar08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kirti G Sonawane 
Designation  Postgraduate 
Affiliation  MIDSR Dental College Latur 
Address  Department of Orthodontics and Dentofacial Orthopaedics MIDSR dental college Latur

Latur
MAHARASHTRA
413512
India 
Phone  7720821889  
Fax    
Email  kirtisonawane96@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Kirti G Sonawane 
Designation  Postgraduate 
Affiliation  MIDSR Dental College Latur 
Address  Dept of Orthodontics and Dentofacial Orthopaedics MIDSR Dental college Latur

Latur
MAHARASHTRA
413512
India 
Phone  7720821889  
Fax    
Email  kirtisonawane96@gmail.com  
 
Source of Monetary or Material Support  
Self supported(by Dr. Kirti Sonawane and Dr. Pravinkumar Maroore). Monetary support from MIDSR Dental college vishvanathpuram ambajogai road Latur,Maharashtra, India 413512 
 
Primary Sponsor  
Name  MIDSR Dental College Latur 
Address  MIDSR Dental college vishwanathpuram,ambajogai road Latur, Maharashtra, India 413512 
Type of Sponsor  Other [Private Dental College] 
 
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 Kirti G Sonawane  MIDSR Dental college Latur  Department of Orthodontics and Dentofacial Orthopaedics Midsr Dental college Latur
Latur
MAHARASHTRA 		 7720821889

kirtisonawane96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee MIDSR Latur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Denosumab injection- A Monoclonal Antibody  5mg/ml local submucosal injection to the first molar buccal site of one arch and opposite side of second arch as it is a split mouth study.follow up taken for next 6 months from the start of treatment.Total duration is 6 months 
Comparator Agent  Sterile water local injection  Sterile water for injection will be given similarly on the buccal aspect of the maxillary and mandibular first molars on the control side during the start of the retraction stage of the orthodontic treatment.followup for further 6 months.total duration is 6 months 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  patients with orthodontic first premolars extraction,angles class I molars relation, Dentoalveolar Proclination, mild crowding 
 
ExclusionCriteria 
Details  hypocalcemic patients, patients allergic to drug, Immunocompromized patients, pregnant patients, not on other bone related medication 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To evaluate the effect of Denosumab on the amount of mesial movement of molar.
2) 2) To evaluate the effect of Denosumab on the amount of anterior retraction 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare effect of Denosumab in en-masse and two step anterior retraction.  6 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2/ Phase 3 
Date of First Enrollment (India)   29/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kirtisonawane96@gmail.com].

  6. For how long will this data be available start date provided 02-08-2025 and end date provided 02-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   aim of the study is to assess the effect of denosumab on the anchorage control. It is a split mouth randomized controlled trial. intervention is a denosumab drug and and sterile injection as a control site. to check the drug effect on mesialisation of molars and the anterior teeth ditalization. anchorage control is checked through lateral cephalograms taken 0,3,6 months timely intervals. 
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