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NCT Number: NCT07795073

Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners

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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Key information

Conditions

Orthodontic Tooth Movement

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Faculty of Dentistry Sanaa university

Sanaa, Sanaa Governorate, 009671, Yemen

About this study

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:

  • Clear aligner + photobiomodulation (PBM) : receives low-level laser therapy at specific intervals to stimulate cellular turnover and bone remodeling
  • Clear aligner +platelet-rich plasma (PRP) :receives localized autologous injections in the target tooth movement area to facilitate biological response
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Rate of clinical tooth movement via intraoral digital scans

    Time frame: 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

  1. Root apex displacement

    Time frame: Baseline and 6 months

    Assessment of root apex displacement in millimeters using CBCT superimposition

  2. Patient-Reported Pain Level

    Time frame: 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.

  3. Root resorption

    Time frame: Baseline and 6 months

    Assessment of root resorption in millimeters using CBCT superimposition

  4. Peri-tooth alveolar bone density

    Time frame: Baseline and 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Naela M Al-mogahed, Prof

CONTACT

[email protected]

+967777962002

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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