NCT04016727

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

January 20, 2020

Conditions

Keywords

tooth movementplatelet rich plasma

Outcome Measures

Primary Outcomes (1)

  • canine movement in mili meters

    distance was measured using vernier caliper at mid cervical and incisal region

    1 month

Study Arms (2)

PRP group

EXPERIMENTAL

patients in which 60 units of prp was injected

Biological: platelet rich plasma

Control group

NO INTERVENTION

patients not given any intervention

Interventions

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.

PRP group

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients requiring first premolar extractions

You may not qualify if:

  • patients taking any drugs, steroids, NSAIDs and antibiotics
  • patients with any co morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFID

Rawalpindi, Punjab Province, 46100, Pakistan

Location

Study Officials

  • sana tariq, BDS

    AFID rawalpindi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 11, 2019

Study Start

July 2, 2018

Primary Completion

March 2, 2019

Study Completion

February 2, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations