NCT06380946

Brief Summary

The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

April 19, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 19, 2024

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter

    rate of orthodontic tooth movement by millimeter

    post interventionalal at 6months

Study Arms (8)

Experimental:iPRF group closure of premolar extraction space

EXPERIMENTAL

closure ofpremolar extraction space that will be performed with iPRFapplication according to a standardized protocol

Biological: iPRF

intervention group

NO INTERVENTION

iPRFgroup closure of premolar extraction space control side

Experimental: iPRFgroup: distalization intervntion side

EXPERIMENTAL

distalization will be commenced with application of iPRF according to a standardized protocol

Biological: iPRF

No Intervention: iPRF group: distalization control side

NO INTERVENTION

distalization will be commenced without application of iPRF according to a standardized protocol

Experimental: iPRF group: leveling and alignment

EXPERIMENTAL

leveling and alignment be commenced with application of iPRF according to a standardized protocol

Biological: iPRF

No Intervention: leveling and alignment without intervention

NO INTERVENTION

leveling and alignment without intervention

Experimental: iPRF group: Intrusion

EXPERIMENTAL

intrusion assisted with application of iPRF according to a standardized protocol

Biological: iPRF

No Intervention: intrusion control group

NO INTERVENTION

intrusion without intervention

Interventions

iPRFBIOLOGICAL

iPRF has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.

Also known as: injectaleplatelets rich fibrin
Experimental: iPRF group: IntrusionExperimental: iPRF group: leveling and alignmentExperimental: iPRFgroup: distalization intervntion sideExperimental:iPRF group closure of premolar extraction space

Eligibility Criteria

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

You may qualify if:

  • \. Age ranges from 15 to 22 years. 2. Bilateral Class II molar relationship. 3. Skeletal Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7. Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit orthodontic movement
  • initial bonding appointment; 6. No required management with interproximal stripping, inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine retraction Eligibility criteria
  • Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous orthodontic treatment; No systemic disease that might have affected bone formation or density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpaI Investigator

Study Record Dates

First Submitted

April 19, 2024

First Posted

April 24, 2024

Study Start

June 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations