- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016727
Variation in Rate of Orthodontic Tooth Movement in Response to Platelet Rich Plasma Therapy
January 20, 2020 updated by: Fatima Hamid, Armed Forces Institute of Dentistry, Pakistan
PRP from 5 ml blood was prepared and 60 units were injected into the buccal vestibule of patient before initiating canine retraction using NiTi coil spring.
Pre and post cervical, incisal and mid distances were measured using Vernier calliper.
Study Overview
Detailed Description
Platelet rich plasma was prepared using patients own blood.
The production of PRP began with a 6-mL homologous blood sample that was withdrawn from the donor via venupuncture.
One milliliter of the blood sample was set apart to determine the concentration of platelets and leukocytes in whole blood.
The remaining 5 mL was mixed with an anticoagulant (3.8%, 1-mL sodium citrate) to prevent clotting.
The blood sample was centrifuged at 113 g for 5 minutes to separate the plasma containing the platelets from the red cells.
The plasma was drawn off the top and centrifuged for an additional 2 minutes at 3772 g to separate the platelets.
Suitable platelet concentrations were achieved by the resuspension of PRP with plasma (high platelet concentration, 5 times the concentration in whole blood).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46100
- AFID
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients requiring first premolar extractions
Exclusion Criteria:
- patients taking any drugs, steroids, NSAIDs and antibiotics
- patients with any co morbid conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRP group
patients in which 60 units of prp was injected
|
Platelet rich plasma was prepared using patients own blood.
60 units of PRP was injected on one side of the arch using insulin syringe.
Each patient served as his/her own control (the side with PRP injected) and experimental group (the side without PRP injected).
Whether the right or left side served as control or experimental was determined by lottery method.
Patients were recalled after 4 weeks and the measurements were repeated again between lateral incisors and canines at mid, cervical and incisal of the teeth and their mean was recorded.
|
No Intervention: Control group
patients not given any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
canine movement in mili meters
Time Frame: 1 month
|
distance was measured using vernier caliper at mid cervical and incisal region
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: sana tariq, BDS, AFID rawalpindi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2018
Primary Completion (Actual)
March 2, 2019
Study Completion (Anticipated)
February 2, 2020
Study Registration Dates
First Submitted
June 28, 2019
First Submitted That Met QC Criteria
July 10, 2019
First Posted (Actual)
July 11, 2019
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 20, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Platelet rich plasma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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