NCT07795073

Brief Summary

This study compares the effectiveness of two adjunct therapies- photobiomodulation (low-level laser therapy) (PBM) and localized platelet-rich plasma (PRP) injections in accelerating orthodontic tooth movement. Participants receiving clear aligner therapy will be randomly assigned to one of three groups: clear aligners with PBM, clear aligners with PRP, or clear aligners alone (control group). The goal is to evaluate the efficiency, tooth movement tracking and safety.

Trial Health

63
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Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Sep 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress14%
Sep 2026May 2027

First Submitted

Initial submission to the registry

August 17, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 17, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

clear aliginerlow- level laser therapyPRPAccelerated tooth movementorthodontics

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical tooth movement via intraoral digital scans

    Quantitative measurement of cumulative linear displacement and dental crown movement (in millimeters) calculated after every 2- aligners sequence (every 4 weeks) measurement will be obtained using digital intra-oral scan superimposed across all three study groups.

    Every 4 weeks from baseline up to 6 months

Secondary Outcomes (4)

  • Root apex displacement

    Baseline and 6 months

  • Patient-Reported Pain Level

    At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.

  • Root resorption

    Baseline and 6 months

  • Peri-tooth alveolar bone density

    Baseline and 6 months

Study Arms (3)

Clear Aligner + Photobiomodulation

EXPERIMENTAL

under a reduced wear-time framework.

Device: photobiomodulation (PBM) TherapyDevice: clear aligner(12-hour wear protocol)

Clear Aligner + Plasma Injection

EXPERIMENTAL

under a reduced wear-time framework

Biological: Platelet Rich Plasma (PRP) injectionDevice: clear aligner(12-hour wear protocol)

Clear Aligner Control Group

ACTIVE COMPARATOR

without any accelerator intervention

Device: Clear aligner(22-hour wear protocol)

Interventions

local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement

Clear Aligner + Plasma Injection

extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement

Clear Aligner + Photobiomodulation

Clear aligner worn for 22-hour on the first day of each aligner stage, followed by a daily wear duration of 12-hour per day for the remaining period in combination with acceleration modalities

Clear Aligner + PhotobiomodulationClear Aligner + Plasma Injection

Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions

Clear Aligner Control Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18- 25 years requiring clear aligner therapy
  • good oral hygiene and health periodontal status
  • full permanent dentition (excluding third molars)
  • willingness to comply with clear aligner wear schedules and follow -up visits.

You may not qualify if:

  • history of previous orthodontic treatment
  • Systemic diseases or conditions affecting bone metabolism
  • Ongoing pharmacological treatment able to influence orthodontic movement (e.g. prostaglandin inhibitors or biphosphonates)
  • Active periodontal disease or poor oral hygiene
  • history of photosensitivity or diseases triggered by light exposure
  • contraindication to PRP blood extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Sanaa university

Sanaa, Sanaa Governorate, 009671, Yemen

Location

MeSH Terms

Interventions

InjectionsLow-Level Light TherapyTherapeutics

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyLaser TherapyPhototherapy

Study Officials

  • Arij L Abdulmajid, MSc

    Sanaa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naela M Al-mogahed, Prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blind study. the outcome assessor and data analyst are blinded to group allocations. blinding the clinician and participants was not feasible due to the nature of PRP and photobiomodulation application.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Trial with three independent groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 31, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08

Locations