- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07795073
Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Naela M Al-mogahed, Prof
- Phone Number: +967777962002
- Email: almogahed2000@yahoo.com
Study Locations
-
-
Sanaa Governorate
-
Sanaa, Sanaa Governorate, Yemen, 009671
- Faculty of Dentistry Sanaa university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clear Aligner + Photobiomodulation
under a reduced wear-time framework.
|
extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
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
|
|
Experimental: Clear Aligner + Plasma Injection
under a reduced wear-time framework
|
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
local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
|
|
Active Comparator: Clear Aligner Control Group
without any accelerator intervention
|
Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Every 4 weeks from baseline up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Root apex displacement
Time Frame: Baseline and 6 months
|
Assessment of root apex displacement in millimeters using CBCT superimposition
|
Baseline and 6 months
|
|
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.
|
At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.
|
|
Root resorption
Time Frame: Baseline and 6 months
|
Assessment of root resorption in millimeters using CBCT superimposition
|
Baseline and 6 months
|
|
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.
|
Baseline and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arij L Abdulmajid, MSc, Sanaa University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Acceleration Clear Aligner
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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