Orthodontic Tooth MovementPhase 1/2NCT07795073
Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners
A Phase 1/2 study testing Platelet Rich Plasma (PRP) injection, photobiomodulation (PBM) Therapy and clear aligner(12-hour wear protocol) in people with Orthodontic Tooth Movement, run by Sana'a University at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Platelet Rich Plasma (PRP) injection, photobiomodulation (PBM) Therapy and clear aligner(12-hour wear protocol)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteYemen
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site
Faculty of Dentistry Sanaa university
Sanaa, Sanaa Governorate, 009671
About this study
Official 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
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:
- 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.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Platelet Rich Plasma (PRP) injection, photobiomodulation (PBM) Therapy, clear aligner(12-hour wear protocol), Clear aligner(22-hour wear protocol)
- Keywords
- clear aliginer, low- level laser therapy, PRP, Accelerated tooth movement, orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (PRP) injectionBiological
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) TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligner + Photobiomodulation | Experimental | under a reduced wear-time framework. Receives: Device: photobiomodulation (PBM) Therapy; Device: clear aligner(12-hour wear protocol) |
| Clear Aligner + Plasma Injection | Experimental | under a reduced wear-time framework Receives: Biological: Platelet Rich Plasma (PRP) injection; Device: clear aligner(12-hour wear protocol) |
| Clear Aligner Control Group | Active comparator | without any accelerator intervention Receives: Device: Clear aligner(22-hour wear protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 4 weeks from baseline up to 6 months
Secondary outcomes (4)
Root apex displacement
Assessment of root apex displacement in millimeters using CBCT superimposition
Measured: Baseline and 6 months
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.
Measured: At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.
Root resorption
Assessment of root resorption in millimeters using CBCT superimposition
Measured: Baseline and 6 months
Peri-tooth alveolar bone density
Assessment of peri-tooth alveolar bone density changes in Hounsfield Unit (HU) using CBCT superimposition.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial with three independent groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arij Lutf Abdulrhman Abdul Majid, Sana'a University
- Investigators
- Arij L Abdulmajid, MSc, Principal investigator, Sanaa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795073
- Sponsor's protocol ID
- Acceleration Clear Aligner
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No