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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04885842
Other study ID # TishreenU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2019
Est. completion date March 3, 2021

Study information

Verified date March 2021
Source Tishreen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 3, 2021
Est. primary completion date February 18, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
injection I-PRF
injection I-PRF with brackets

Locations

Country Name City State
Syrian Arab Republic Tishreen University Latakia

Sponsors (1)

Lead Sponsor Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (2)

Baldridge DW. Leveling the curve of Spee: its effect on mandibular arch length. JPO J Pract Orthod. 1969 Jan;3(1):26-41. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary alignment and leveling Improvement Percentage(ALIP): Determining the percentage of improvement in alignment and leveling by calculating the value of the change in the Little index in one of the studied time periods (T1) or (T2) or (T3) which is calculated by subtracting the value of the Little index at the studied period of time from the value of the Little index at (T0) When the primary wire is inserted, the value of the little index at (T0) is multiplied by 100 Through the following 6 Month
Secondary Overall Alignment and Leveling Time the overall time required to complete the leveling and alignment was calculated by calculating the number of days between (To) and (T3). 6 Month
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