Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling

May 13, 2021 updated by: Tishreen University

Evaluation of the Efficacy of Injection Platelet-rich Fibrin(I-PRF) in Accelerate Alignment and Leveling in an Adult Sample

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.

Study Overview

Status

Completed

Intervention / 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

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 24 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group
injection I-PRF with brackets
injection I-PRF with brackets
Other Names:
  • control Group
NO_INTERVENTION: Control Group
applying brackets only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alignment and leveling Improvement Percentage(ALIP):
Time Frame: 6 Month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Alignment and Leveling Time
Time Frame: 6 Month
the overall time required to complete the leveling and alignment was calculated by calculating the number of days between (To) and (T3).
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2019

Primary Completion (ACTUAL)

February 18, 2021

Study Completion (ACTUAL)

March 3, 2021

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 9, 2021

First Posted (ACTUAL)

May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • TishreenU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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