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Not yet recruitingNCT07795073Updated Aug 31, 2026

Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners

A Phase 1/2 interventional study of Platelet Rich Plasma (PRP) injection and photobiomodulation (PBM) Therapy in Orthodontic Tooth Movement, sponsored by Sana'a University. Not yet recruiting at 1 site in Yemen. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Sana'a University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

This randomized controlled clinical trial evaluates the acceleration orthodontic tooth movement using two adjunct biological stimulation modalities in patients under going clear aligners therapy participant are allocated into three groups:

  1. Clear aligner + photobiomodulation (PBM) : receives low-level laser therapy at specific intervals to stimulate cellular turnover and bone remodeling
  2. Clear aligner +platelet-rich plasma (PRP) :receives localized autologous injections in the target tooth movement area to facilitate biological response
  3. Clear aligners alone: (control group )receiving standard clear aligners treatment without additional interventions.

Outcomes will be evaluated periodically using digital intra-oral scanning to measure tracking, accuracy, rate of orthodontic tooth movement, and soft tissue - periodontal health throughout the active treatment period.

02

Conditions studied

  • Orthodontic Tooth Movement

Keywords

  • clear aliginer
  • low- level laser therapy
  • PRP
  • Accelerated tooth movement
  • orthodontics
03

In context

Lead sponsor

Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • to PRP blood extraction
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Clear Aligner + Photobiomodulation

    under a reduced wear-time framework.

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

  • Experimental
    Clear Aligner + Plasma Injection

    under a reduced wear-time framework

    Biological: Platelet Rich Plasma (PRP) injection · Device: clear aligner(12-hour wear protocol)

  • Active comparator
    Clear Aligner Control Group

    without any accelerator intervention

    Device: Clear aligner(22-hour wear protocol)

Interventions

  • BiologicalPlatelet Rich Plasma (PRP) injection

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

  • Devicephotobiomodulation (PBM) Therapy

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

  • Deviceclear aligner(12-hour wear protocol)

    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

  • DeviceClear aligner(22-hour wear protocol)

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

06

What researchers measure

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.

    Time frame: Every 4 weeks from baseline up to 6 months

Secondary outcomes

  1. Root apex displacement

    Assessment of root apex displacement in millimeters using CBCT superimposition

    Time frame: Baseline and 6 months

  2. Patient-Reported Pain Level

    Pain intensity is evaluated using the Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse pain.

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

  3. Root resorption

    Assessment of root resorption in millimeters using CBCT superimposition

    Time frame: Baseline and 6 months

  4. Peri-tooth alveolar bone density

    Assessment of peri-tooth alveolar bone density changes in Hounsfield Unit (HU) using CBCT superimposition.

    Time frame: Baseline and 6 months

07

Study locations

1 site
  • Faculty of Dentistry Sanaa university
    Sanaa, Sanaa Governorate 009671, Yemen
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 31, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Apr 1, 2027
CompletionEst.
May 1, 2027
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07795073
Lead sponsor
Sana'a University
Responsible party
Arij Lutf Abdulrhman Abdul Majid (PhD student, Sana'a University) — Principal investigator
First posted
Aug 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Aug 31, 2026

Study contacts

Naela M Al-mogahed, Prof
Contact
almogahed2000@yahoo.com
+967777962002
Arij L Abdulmajid, MSc
principal investigator · Sanaa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Platelet rich plasma

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Sana'a University

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