Orthodontic Tooth Movement
Conditions
Keywords
clear aliginer, low- level laser therapy, PRP, Accelerated tooth movement, orthodontics
Brief 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.
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.
Interventions
BIOLOGICALPlatelet Rich Plasma (PRP) injection
local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
DEVICEclear aligner(12-hour wear protocol)
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
DEVICEClear aligner(22-hour wear protocol)
Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is a single-blind study. the outcome assessor and data analyst are blinded to group allocations. blinding the clinician and participants was not feasible due to the nature of PRP and photobiomodulation application.
Intervention model description
Trial with three independent groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Yemen
Contacts
CONTACTNaela M Al-mogahed, Prof
PRINCIPAL_INVESTIGATORArij L Abdulmajid, MSc
Sanaa University
Outcome results
None listed