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CTRI Number  CTRI/2025/05/087949 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Speeding up braces with platelet-rich plasma. 
Scientific Title of Study   The effect of locally administered platelet-rich plasma injection on the acceleration of orthodontic tooth movement: A Split mouth 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  Shailesh Ram Kulkarni 
Designation  Post Graduate MDS student 
Affiliation  Aditya Dental College Beed 
Address  Renukai Niwas near Jidnyasa classes Bhagyanagar Beed
Room no.8 department of orthodontics Aditya dental college and hospital Beed
Bid
MAHARASHTRA
431122
India 
Phone  7058034968  
Fax    
Email  shaileshkulkarni000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Handa 
Designation  Professor 
Affiliation  Aditya Dental College Beed 
Address  Aditya Dental College Beed
Room no. 8 Department of orthodontics Aditya dental college and hospital beed.
Bid
MAHARASHTRA
431122
India 
Phone  9960573397  
Fax    
Email  handaamit1986@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Handa 
Designation  Professor 
Affiliation  Aditya Dental College Beed 
Address  Aditya Dental College Beed
Room no. 8 Department of orthodontics Aditya dental college and hospital beed.
Bid
MAHARASHTRA
431122
India 
Phone  9960573397  
Fax    
Email  handaamit1986@gmail.com  
 
Source of Monetary or Material Support  
Aditya Dental College & Hospital, Sarda Estate Pimpalner Road, Beed, Maharashtra-431122 INDIA 
 
Primary Sponsor  
Name  Shailesh Kulkarni 
Address  Aditya Dental College & Hospital, Sarda Estate Pimpalner Road, Beed, Maharashtra-431122 INDIA 
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 Amit Handa  Aditya dental college and hospital Beed  Room no.8 department of orthodontics Aditya dental college and hospital sarda estate beed 431122
Bid
MAHARASHTRA 
9960573397

handaamit1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aditya dental college and hospital esthics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet Rich Plasma  Intervention: The intervention involves the use of Platelet-Rich Plasma (PRP) prepared from the patient’s own blood. A small amount of venous blood will be collected and processed using a standard centrifugation protocol to isolate PRP. In each patient, PRP will be injected locally into the buccal and palatal mucosa adjacent to the maxillary canine and premolar region on one side of the arch. The injections will be administered at the start of the retraction phase and repeated every 4 weeks for a total of three applications. The purpose of the PRP application is to evaluate its effect on the rate of orthodontic tooth movement during en-masse retraction. 
Comparator Agent  PLETELET RICH PLASMA  Comparator: In this split-mouth study design, the contralateral side of the same dental arch will serve as the control. No PRP will be applied on this side. All other orthodontic procedures—including bracket placement, archwire sequence, and retraction mechanics—will remain identical on both sides to ensure a uniform comparison. The rate of tooth movement between the PRP-treated side and the control side will be measured and analyzed. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients aged more than 12 years
2) Patients with moderate crowding in the anterior maxilla where extraction is indicated
3) Patients with no history of orthodontic treatment
4) patients with no history of systemic diseases (specifically blood-related disorders)
 
 
ExclusionCriteria 
Details  1) Patients who had blood-related disorders
2) Patients took anticoagulant drugs that affected bone metabolism, for example, heparin, warfarin, NSAIDs, cyclosporine, glucocorticoids, medroxyprogesterone acetate, and thyroid hormones.
3) Patients with severe tooth displacement like ectopic canine
4) Previous history of orthodontic treatment 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the rate of orthodontic tooth movement during the en-masse retraction phase. Tooth movement will be measured at baseline, 3 weeks, 6 weeks, and 9 weeks on both the PRP-treated and control sides using standardized intraoral measurements on dental casts or intraoral photographs. The difference in tooth movement between the two sides will be analyzed to assess PRPs effectiveness in accelerating tooth movement. This outcome is used in the sample size calculation.  at baseline, 3 weeks, 6 weeks, 9 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean amount of canine retraction (in mm) on the PRP-injected side compared to the control side  21 days
42 days
63 days 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 
Date of First Enrollment (India)   15/06/2025 
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="1"
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  

Orthodontic treatment, aimed at correcting malocclusions and enhancing dental aesthetics, typically involves a prolonged duration due to the natural constraints of bone architecture. One of the main deterrents for patients to decline orthodontic treatments is the inconvenience of having long-term procedures. The canine retraction is one such common procedure that might take up to seven to eight months for its completion. So the concept of accelerating orthodontic tooth movement (OTM) has garnered significant interest among orthodontists and researchers alike, seeking to reduce treatment duration and enhance the patient experience. Over time, several methods have been developed to shorten the course of treatment.

Microimpulses, low-dose laser therapy, and pharmaceuticals are examples of such noninvasive techniques. Surgically assisted methods including corticision, micro-osteoperforation, piezocision, periodontal ligament distraction, and periodontally accelerated osteogenic orthodontics are examples of invasive treatments. Research has demonstrated that invasive procedures harm the alveolar bone. The mechanical simulation brought on by invasive procedures increases osteoclastic activity, which in turn causes the alveolar bone to resorb, reducing its density and causing the targeted teeth’s bone to disappear.

Platelet-rich plasma (PRP) is currently utilized across numerous medical specialties and has been viewed as an orthobiological adjuvant therapy in recent times. Because PRP is being used for a variety of purposes in dermatology, including tissue regeneration, wound healing, scar revision, skin rejuvenating benefits, and alopecia, interest in its usage has recently exploded. PRP has the ability and potential to encourage periodontal regeneration via a variety of methods. The concentration of PRP employed determines its impact on the localized acceleration of tooth movement. Nonetheless, the effectiveness of PRP-based tooth movement acceleration depends on the synthesis method. Injectable PRP can influence bone quality and accelerate tooth movement, therefore using it at a different stage of orthodontic therapy can improve the quality of the outcome.

This study aims to investigate the effect of locally administered PRP injections on accelerating orthodontic tooth movement through a split-mouth study design. By administering PRP on the Experimental side of the oral cavity while using conventional orthodontic mechanics on the control side, the study seeks to isolate and evaluate the specific impact of PRP on the rate of tooth movement.

Understanding the underlying mechanisms through which PRP influences orthodontic tooth movement is crucial for optimizing treatment protocols and enhancing clinical outcomes. This study will not only contribute to the growing body of evidence in the field of orthodontics but also holds the potential to revolutionize orthodontic practice by offering a safe and effective means of expediting treatment duration while ensuring optimal patient outcomes.

This study will explore the complex relationship between PRP injection and orthodontic tooth movement to offer insightful information that can guide evidence-based clinical practice and open the door to more developments in orthodontic therapy.

 
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