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Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners

NCT07795073 — Phase 1 / Phase 2, Not yet recruiting, 42 participants, Sana'a University

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Evaluation and Comparison of Acceleration of Tooth Movement Using Platelet-Rich Plasma (PRP) and Photobiomodulation (PBM) With Clear Orthodontic Appliances (Aligners): A Randomized Controlled Clinical Trial

RegistryNCT07795073
StatusNot yet recruiting
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment42 (Estimated)
SponsorSana'a University (Other)
ConditionsOrthodontic Tooth Movement
InterventionsPlatelet Rich Plasma (PRP) injection, photobiomodulation (PBM) Therapy, clear aligner(12-hour wear protocol), Clear aligner(22-hour wear protocol) (Biological, device)
Datesstart 2026-09-01 (estimated), primary completion 2027-04-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-08-31, last updated 2026-08-31
Locations1 site in Yemen

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Clear Aligner + PhotobiomodulationExperimentalDevice: photobiomodulation (PBM) Therapy; Device: clear aligner(12-hour wear protocol)under a reduced wear-time framework.
Clear Aligner + Plasma InjectionExperimentalBiological: Platelet Rich Plasma (PRP) injection; Device: clear aligner(12-hour wear protocol)under a reduced wear-time framework
Clear Aligner Control GroupActive comparatorDevice: Clear aligner(22-hour wear protocol)without any accelerator intervention
  • Platelet Rich Plasma (PRP) injection (Biological): local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
  • photobiomodulation (PBM) Therapy (Device): extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
  • clear aligner(12-hour wear protocol) (Device): 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(22-hour wear protocol) (Device): Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions

+Outcome measures

Primary outcomes

  • Rate of clinical tooth movement via intraoral digital scans [Every 4 weeks from baseline up to 6 months]: 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.

Secondary outcomes

  • Root apex displacement [Baseline and 6 months]: Assessment of root apex displacement in millimeters using CBCT superimposition
  • Patient-Reported Pain Level [At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.]: 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.
  • Root resorption [Baseline and 6 months]: Assessment of root resorption in millimeters using CBCT superimposition
  • Peri-tooth alveolar bone density [Baseline and 6 months]: Assessment of peri-tooth alveolar bone density changes in Hounsfield Unit (HU) using CBCT superimposition.

+Eligibility

Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers

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:

* 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

+Locations (1)

FacilityCityCountryStatus
Faculty of Dentistry Sanaa universitySanaa, Sanaa GovernorateYemen

+Investigators

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