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
| Registry | NCT07795073 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 42 (Estimated) |
| Sponsor | Sana'a University (Other) |
| Conditions | Orthodontic Tooth Movement |
| Interventions | Platelet Rich Plasma (PRP) injection, photobiomodulation (PBM) Therapy, clear aligner(12-hour wear protocol), Clear aligner(22-hour wear protocol) (Biological, device) |
| Dates | start 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 |
| Locations | 1 site in Yemen |
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All trials for Orthodontic Tooth Movement All trials of Platelet Rich Plasma (PRP) injection All trials of photobiomodulation (PBM) Therapy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Clear Aligner + Photobiomodulation | Experimental | Device: photobiomodulation (PBM) Therapy; Device: clear aligner(12-hour wear protocol) | under a reduced wear-time framework. |
| Clear Aligner + Plasma Injection | Experimental | Biological: Platelet Rich Plasma (PRP) injection; Device: clear aligner(12-hour wear protocol) | under a reduced wear-time framework |
| Clear Aligner Control Group | Active comparator | Device: Clear aligner(22-hour wear protocol) | without any accelerator intervention |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Dentistry Sanaa university | Sanaa, Sanaa Governorate | Yemen |