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Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners

ConditionOrthodontic Tooth Movement
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-25
SponsorSana'a University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet Rich Plasma (PRP) injection

    Biological/Vaccine

    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

Treatment groups

42 Participants
are divided into 3 treatment groups
Group A: Clear Aligner + PhotobiomodulationExperimental treatment 2 interventions
Group B: Clear Aligner + Plasma InjectionExperimental treatment 2 interventions
Group C: Clear Aligner Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Every 4 weeks from baseline up to 6 months

Secondary outcomes

1

Root apex displacement

Assessment of root apex displacement in millimeters using CBCT superimposition

Time frame
Baseline and 6 months
2

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.

Time frame
At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.
3

Root resorption

Assessment of root resorption in millimeters using CBCT superimposition

Time frame
Baseline and 6 months
4

Peri-tooth alveolar bone density

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

Time frame
Baseline and 6 months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Dentistry Sanaa university Status unavailable 009671, Sanaa, Sanaa GovernorateYemenYemen

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sana'a University

Lead sponsor

Source ClinicalTrials.gov

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