- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562452
Evaluating the Effect of Injectable Platelet Rich Fibrin on Tooth Movement
Introduction: Prolonged orthodontic treatment can lead to challenges and unfavourable outcomes, including increased risk of caries, root resorption, as well as gingival and periodontal diseases. Acceleration of this step would reduce overall treatment time, improve patient cooperation, and decrease possible negative side effects. The injectable platelet - rich fibrin is second generation holds the advantages of easier preparations and longer effects that is obtained through low-speed centrifugation. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy.
Objective: Our study aims to investigate the effectiveness of i PRF in accelerating maxillary canine retraction Subjects and method: This study was a split-mouth randomized clinical trial was conducted on 31 patients (9 male, 22 females age ranging 14-31 years) who were treated for Class I malocclusion with the extraction of the maxillary first premolar. After the leveling and alignment phase, the canines were retracted with 150gm forces. The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites. Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement, acceleration of canine retraction and space closure would reduce overall treatment time. Tooth movement is essentially a biological response to a physical stimulus, speeding up this response should avoid the occurrence of common iatrogenic effects such as white spot lesions, caries, root resorption and periodontal problems 1. Therefore, attempts to accelerate tooth movement and reduce treatment duration are of great significance to both orthodontists and patients. Thus, various invasive and non-invasive modalities have been attempted to reduce the duration of orthodontic treatment by accelerating tooth movement such as: surgical, vibration, pharmacological agents, low-level laser therapy or other procedures 2,3,4,5. However, none of these procedures have yet become a gold standard method. Platelet-based preparations from the patient's blood provide a safe alternative to commercially available bioactive materials. Platelet-rich fibrin (PRF) is the second generation, holds the advantages of easier preparations and longer effects 6-11. The injectable platelet-rich fibrin (i-PRF) was developed as an advanced product of PRF by altering the centrifugation protocol by lowering the centrifugation speed and force to 700 rotations per minute within 3 minutes. has many advantages over the conventional form such as higher rates of leukocyte, regenerative cells and growth factors. The potential benefits of PRF have been widely investigated in regenerative dentistry and oral surgery such as tooth movement, implantology, oral pathology and periodontal therapy 12,13,14. Wang et al. reported that i-PRF affected osteoblastic behavior remarkably by influencing its migration, proliferation, and differentiation. This promotes cellular activity and accelerates bone turnover and healing 11.
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cần Thơ, Vietnam, 900000
- Can Tho University of Medicine and Pharmacy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants (age>12 years old) with Class I malocclusion requiring extraction of maxillary first premolar
- No previous orthodontic treatment
- Absence of systemic diseases and dentofacial anomalies
- Participant agreed to participate in the study
Exclusion criteria:
- Participants with periodontal diseases, craniofacial syndromes such as cleft lip or palate, systemic diseases related to bone metabolism
- Taking anticoagulants or medication that interferes with orthodontic tooth movement for example, heparin, warfarin, NSAIDs, cyclosporine, glucocorticoids, medroxyprogesterone acetate, thyroid hormones,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Right sides were randomly allocated to treatments with i-PRF
The amount of i-PRF was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control.
|
fter the leveling and alignment phase, the canines were retracted with 150gm forces.
The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites.
Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
|
|
Experimental: Left sides were randomly allocated to control sides.
The placebo was standardized as 2mL and was injected submucosal into the distobuccal and distopalatal side of the canine tooth (1mL for each side) under local anesthesia for pain control.
|
fter the leveling and alignment phase, the canines were retracted with 150gm forces.
The i-PRF was prepared from the blood of each patient then injected immediately before canine retraction on the buccal and palatal aspects of the extraction sites.
Digital model were obtained at five time points: before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4) from the beginning of distalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The purpose of this study was to investigate the efficiency of i-PRF in accelerating tooth movement.
Time Frame: Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)
|
Digital models were scanned using the iTero scanner (Align Technology, Inc, USA) assessed by Medit Link software at 5 time points (5 months)
|
Our study aims to investigate the effectiveness of i PRF in accelerating maxilary canine retraction at 5 time points (5 months): before tooth extraction (T0) and in the fourth week (T1), eighth week (T2), twelfth week (T3), sixteenth week (T4)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- LeNguyenLamCTUMP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Angle Class I
-
Hesham Nabil Ali Al-QamhawyAl-Azhar UniversityRecruitingBimaxillary Protrusion | Malocclusion, Angle Class II, Division 1 | Class I MalocclusionEgypt
-
Bezmialem Vakif UniversityPEBS DENTAL CLINICRecruitingClass II Div 1 Malocclusion | Class III Malocclusion | Class II Division 2 Malocclusion | Class I MalocclusionTurkey (Türkiye)
-
State University of New York at BuffaloCompletedDental Malocclusion | Crowding, Tooth | Angle Class II | Angle Class IUnited States
-
Can Tho University of Medicine and PharmacyCompletedAngle Class IVietnam
-
Postgraduate Institute of Dental Sciences RohtakCompleted
-
Mersin UniversityCompletedCrowding, Tooth | Angle's Class I MalocclusionTurkey
-
Can Tho University of Medicine and PharmacyCompleted
-
AL YousefKing Abdullah International Medical Research CenterUnknownMalocclusion, Angle Class I | Malocclusion; Angle Class II Division 1Saudi Arabia
-
Al-Azhar UniversityRecruitingOrthodontic Tooth Movement | Class I Malocclusion | Maxillary PrognathismEgypt
-
Cairo UniversityRecruiting
Clinical Trials on Injectable platelet rich fbirin
-
Can Tho University of Medicine and PharmacyCompleted
-
Wroclaw Medical UniversityEnrolling by invitationTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisPoland
-
Al-Azhar UniversityEnrolling by invitationEffect of Platelet Rich Fibrin Tooth MovementEgypt
-
Al-Azhar UniversityEnrolling by invitationEffect of Platelet Rich Fibrin With Different Tooth MovementsEgypt
-
Ain Shams UniversityCompleted
-
Kutahya Health Sciences UniversityRecruitingPeri-Implant TissuesTurkey (Türkiye)
-
Postgraduate Institute of Dental Sciences RohtakNot yet recruiting
-
October 6 UniversityCompletedPlatelet Rich Fibrin | Esthetic Zone | Symphysis Onlay Bone Graft | Xenograft | Horizontal Alveolar Ridge AugmentationEgypt
-
Al-Azhar UniversityEnrolling by invitationCompare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of IncisorsEgypt
-
Al-Azhar UniversityEnrolling by invitationEffects of; Movement of Teeth Assiste Wit MOPS and I-prfEgypt