NCT05616936

Brief Summary

The present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases

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
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

3 months

First QC Date

November 9, 2022

Last Update Submit

November 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • effect of injectable platelet rich fibrin on different tooth movements

    rate of tooth movement

    post interventional at 4 months

Study Arms (6)

Group I

EXPERIMENTAL

Intervention side: application of i-PRF with distalization of maxillary first molar that will be performed on intervention sides according to a standardized protocol.

Biological: injectable platelet rich fibrin

Group II

NO INTERVENTION

Control side: distalization of maxillary first molar that will be performed without any intervention

Group A

EXPERIMENTAL

levelling and alignment assisted with Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol.

Biological: injectable platelet rich fibrin

Group B

NO INTERVENTION

leveling and alignment will be commenced without Injection of Injectable platelet-rich fibrin (i-PRF)

Group a

EXPERIMENTAL

Will includes 9 patients who will receive intrusive arch after leveling and alignment assisted Injectable Platelet-rich fibrin (i-PRF) according to a standardized protocol.

Biological: injectable platelet rich fibrin

Group b

NO INTERVENTION

Will includes 9 patients who will receive intrusive utility arches after leveling and alignment without Injection of Injectable platelet-rich fibrin (i-PRF)

Interventions

injectable platelet rich fibrin

Group AGroup IGroup a

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All permanent teeth present, 3rd molars are excluded. Good oral and general health. No systemic disease/medication that could interfere with orthodontic tooth movement. No previous orthodontic treatment.

You may not qualify if:

  • Poor oral hygiene or periodontally compromised patient. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university

Cairo, Egypt

Location

Related Publications (2)

  • Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.

    PMID: 33481053BACKGROUND
  • Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.

    PMID: 33459765BACKGROUND

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Factorial Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 15, 2022

Study Start

January 1, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations