Clinical trial NCT04885842: Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling
Official title: Evaluation of the Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling in an Adult Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Pathological Resorption of External Root
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical study ,two parallel groups design. The research sample consisted of 18 patients (11 famales,7 males)Patients were randomly assigned to 2 groups using the sample randomization principle. Each group included 8 patient (9 control group applying brackets only)(9 group injection I-PRF with brackets).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: the aim of this study is to evaluate the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment.

Detailed description: What remains the most important and common question for adult patients who want to undergo orthodontic treatment is how long the treatment will take, as the period of orthodontic treatment may take between 18 and 24 months in some cases of malocclusion ,and this may cause discomfort for the patient and reduce cooperation during treatment in addition to the aesthetic problems associated with presence of bracket.

the possibility of an increase of Enamel mineral dissolution and spread of dental caries ,gingival problems and this is due to the increase of the duration of orthodontic treatment.

Orthodontic treatment begins with the leveling and alignment stage and constitutes an important part of the treatment stages, during which the teeth(incisal edges, cusps posterior teeth) are placed on one level and to achieve perfect points of contact between the teeth In some cases of malocclusion especially severe ones, this stage may take about 8 months therefore , the interest of orthodontics has increased in finding new methods and techniques in order to accelerate treatment, Various methods and techniques have been used to accelerate orthodontic treatment Which includes :biomaterial injection, surgical and physical methods. Yet, despite the effectiveness of some of these methods in accelerating dental movement ,each of its disadvantages and side effects on the patient therefore, attention must be paid to anther effective safe and simple non-traumatic method hence the idea of using platelet rich fibrin came.

Platelet rich fibrin is a therapeutic approach and it is a new generation of platelet concentrates Which was introduced to the field of dentistry by choukroun in 2001 who developed this treatment technique.

Platelet rich fibrin injection technology (I-PRF), which is obtained in liquid form for injection has been developed through the concept of reduced speed centrifugation .

PRF is a biomaterial .Autologus is taken from a person's own blood.Unlike PRP, no external bioactive are added to active platelet. Rather, the blood sample remains normal. The importance and therapeutic benefits of platelet-rich fibrin come through the presence of key and other common elements that collectively contribute to the healing processes and regeneration of the soft and bone tissues represented by the presence of fibrin in the form of a matrix with large and significant numbers of leukocytes, cytokines, platelets, in addition to the participation of growth factors which play an important role in the processes of healing.

Platelet rich fibrin is a simple, easy to apply and economical technique that does not require adding any substances to the blood sample as an anticoagulant.

To date, there are no studies on the role that platelet rich fibrin injection can play in accelerating aligning and leveling the upper anterior teeth and reducing the time required for treatments Therefore the aim of study is to verify the effectiveness of injection I-PRF to accelerate alignment and leveling of the upper anterior teeth and reduce the time required for treatment

Eligibility criteria: Inclusion Criteria:

The Clinical Diagnosis the age of patients ranges between 16-24 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification,

Exclusion Criteria:

the presence of any systemic disease that affects the orthodontic movement Diabetes , a patient undergoing previous orthodontic treatment, a patient who takes medicines Cortisone,NSAIDs the affect dental movement . and the presence of bleeding disorders Disturbance in the number of platelets.

Primary outcomes:
measure: alignment and leveling Improvement Percentage(ALIP):
timeFrame: 6 Month
Secondary outcomes:
measure: Overall Alignment and Leveling Time
timeFrame: 6 Month
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
References:
citation: The gliding path of the mandible along the skull. Ferdinand Graf Spee (1855-1937), prosector at the Anatomy Institute of Kiel. J Am Dent Assoc. 1980 May;100(5):670-5. No abstract available.
citation: Baldridge DW. Leveling the curve of Spee: its effect on mandibular arch length. JPO J Pract Orthod. 1969 Jan;3(1):26-41. No abstract available.