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
|
|
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
|
|
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. | |