NCT07103551

Brief Summary

Aim of the study is evaluation of the efficacy of injectable platelet-rich plasma in orthodontic tooth movement acceleration with clear aligner

Trial Health

35
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_3

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_3

Status
not yet recruiting

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

July 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

July 29, 2025

Last Update Submit

August 4, 2025

Conditions

Clear Aligner Appliance

Keywords

MalocclusionClear alignerPlatelet-rich plasma

Outcome Measures

Primary Outcomes (1)

  • Measuring the amount of tooth movement in group of clear aligner therapy and group of clear aligners with injectable platelet-rich plasma by little's irregularity index

    Little's irregularity index is used to measure the amount of tooth movement by measuring the distance between each contact points in anterior teeth before injection and after injection

    Baseline, 3 weeks, and 6 weeks

Study Arms (2)

Clear aligner therapy only without injection of platelet-rich plasma

NO INTERVENTION

Clear aligner only without acceleration

Clear aligner Therapy with injection of platelet-rich plasma

EXPERIMENTAL

Clear aligner therapy with injection of platelet-rich plasma

Biological: Platelet-rich plasma

Interventions

Platelet-rich plasmaBIOLOGICAL

Platelet-rich plasma used during clear aligner therapy for acceleration of Orthodontic Tooth Movement

Clear aligner Therapy with injection of platelet-rich plasma

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-extraction cases
  • Complete permanent dentition
  • Good oral hygiene
  • Healthy periodontal condition
  • Single or double arch treatment
  • No therapeutic intervention planned intermaxillary or other intraoral or extraoral appliances including lip bumper, elastics and maxillary expansion appliances
  • mild to moderate crowding

You may not qualify if:

  • Systemic medical conditions
  • Dental anomalies in tooth size or shape
  • Current use of anti-inflammatory medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Ali Mahmoud Elhewaity

CONTACT

+201558222026alimahmoud9779@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

August 7, 2025

Record last verified: 2025-08