NCT04885842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
Last Updated

May 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

May 9, 2021

Last Update Submit

May 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall Alignment and Leveling Time

    6 Month

Study Arms (2)

Study Group

EXPERIMENTAL

injection I-PRF with brackets

Other: injection I-PRF

Control Group

NO INTERVENTION

applying brackets only

Interventions

injection I-PRF with brackets

Also known as: control Group
Study Group

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 13, 2021

Study Start

September 14, 2019

Primary Completion

February 18, 2021

Study Completion

March 3, 2021

Last Updated

May 17, 2021

Record last verified: 2021-03

Locations