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

Primary Purpose

Orthodontic Pathological Resorption of External Root

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
injection I-PRF
Sponsored by
Tishreen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Orthodontic Pathological Resorption of External Root

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tishreen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

injection I-PRF with brackets

applying brackets only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
May 9, 2021
Last Updated
May 13, 2021
Sponsor
Tishreen University
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1. Study Identification

Unique Protocol Identification Number
NCT04885842
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tishreen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Pathological Resorption of External Root

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
injection I-PRF with brackets
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
applying brackets only
Intervention Type
Other
Intervention Name(s)
injection I-PRF
Other Intervention Name(s)
control Group
Intervention Description
injection I-PRF with brackets
Primary Outcome Measure Information:
Title
alignment and leveling Improvement Percentage(ALIP):
Description
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
Time Frame
6 Month
Secondary Outcome Measure Information:
Title
Overall Alignment and Leveling Time
Description
the overall time required to complete the leveling and alignment was calculated by calculating the number of days between (To) and (T3).
Time Frame
6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Tishreen University
City
Latakia
Country
Syrian Arab Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
6988491
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.
Results Reference
result
PubMed Identifier
5250875
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.
Results Reference
result
Links:
URL
http://www.academia.edu/15581747/
Description
Introducing Choukroun's platelet rich fibrin (PRF) to the reconstructive surgery milieu. J Implant Adv Clin Dent 2009;1:21-30
URL
http://www.researchgate.net
Description
Une opportunité en paro-implantologie: Le PRF. Implantodontie 2001

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

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