Tooth MovementPhase 4NCT04016727
Variation in Rate of Orthodontic Tooth Movement in Response to Platelet Rich Plasma Therapy
A Phase 4 study testing platelet rich plasma in people with Tooth Movement, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Movement
- What is being tested?
- platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2018to 2 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients requiring first premolar extractions
Who cannot join
- patients taking any drugs, steroids, NSAIDs and antibiotics
- patients with any co morbid conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 The production of PRP began with a 6-mL homologous blood sample that was withdrawn from the donor via venupuncture.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).
- Conditions
- Tooth Movement
- Being tested
- platelet rich plasma
- Keywords
- tooth movement, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | patients in which 60 units of prp was injected Receives: Biological: platelet rich plasma |
| Control group | No intervention | patients not given any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
canine movement in mili meters
distance was measured using vernier caliper at mid cervical and incisal region
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start2 Jul 2018
- Primary completion2 Mar 2019
- Study completion2 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Hamid, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- sana tariq, BDS, Study chair, AFID rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016727
- Sponsor's protocol ID
- platelet rich plasma
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Rate of Orthodontic Tooth Movement in Response to Platelet Rich Plasma Therapy
- ClinicalTrials.gov ID
- NCT04016727
- Acronym / sponsor ID
- platelet rich plasma
- Conditions
- Tooth Movement
- Keywords
- tooth movement, platelet rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 2 Feb 2020 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: platelet rich plasmapatients in which 60 units of prp was injected |
| Control group | No intervention | –patients not given any intervention |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients requiring first premolar extractions
Key exclusion criteria (2 listed)
- patients taking any drugs, steroids, NSAIDs and antibiotics
- patients with any co morbid conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet rich plasmaPlatelet 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. | Biological | PRP group |
Primary outcome
canine movement in mili meters
Time frame: 1 month
distance was measured using vernier caliper at mid cervical and incisal region
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sana tariq, BDS study chair
AFID rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing platelet rich plasma in people with Tooth Movement, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
canine movement in mili meters (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.