Objectives: The effect of autologous leukocyte platelet rich fibrin (LPRF) on the rate of orthodontic tooth movement- a prospective randomized clinical trial
Design: Premolar extraction will be done at eight orthodontic patients after primary. On one side of each jaw, the defects will be preserved as the experimental group by immediately placing LPRF in the extracted socket and will be sutured, the other side will serve as the control group for secondary healing. Immediately, the teeth adjacent to the defects will be pulled together by a NiTi-based closed-coil spring with constant force level. The amounts of OTM will be measured by comparing the changes of distance between the adjacent teeth in two weeks interval for three months. The exact amounts of tooth movement will be measured clinically by Boley Gauge Caliper with sharp tips located at the CEJ of crowns of the casts and then will be compared and double checked by another independent blind examiner.
Primary Outcome Measures: the amount of tooth movement and to compare the amount of tooth movement between maxillary and mandibular arches.
Secondary Outcome Measures: Incidence of mucogingival defects as clinically measured by gingival recession (GR), clinical attachment level (CAL), probing depth (PD), width of keratinized tissue (WKT) and biotype), by a calibrated examiner.
Inclusion Criteria: bilaterally symmetric extraction of premolar teeth; no medicines or systemic illness;
Exclusion Criteria: syndromic &systemic illness or medication like NSAIDS that interfere with OTM; prior orthodontic treatment.
General information
Acronym
rate of orthodontic tooth movement following LPRF
IRCT registration information
IRCT registration number:IRCT2015100724405N1
Registration date:2016-03-23, 1395/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Azita Tehranchi
Name of organization / entity
Dental School Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 3897
Email address
a.tehranchi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Research Center, Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous leukocyte platelet rich fibrin (LPRF) on the rate of orthodontic tooth movement- a prospective randomized clinical trial
Public title
The effect of autologous leukocyte platelet rich fibrin (LPRF) on the rate of orthodontic tooth movement- a prospective randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: more than12 years old patients; bilaterally symmetric extraction of premolar teeth; no medicines or systemic illness; full banding/bonding of teeth in both arches.
Exclusion Criteria: pregnancy; non-extraction treatment; syndromic &systemic illness or medication like NSAIDS that interfere with OTM; prior orthodontic treatment.
Age
From 12 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ETHICAL COMMITTEE,RESEARCH INSTITUTE OF DENTA SCIENCESL
Street address
EVIN DENTAL SCHOOL SHAHID BEHESHTI UNIVERSITY IF MEDICAL SCIENCSES
City
Tehran
Postal code
1983963113
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
9310
Health conditions studied
1
Description of health condition studied
orthodontic tooth movement
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
the amount of tooth movementand to compare the amount of tooth movement between maxillary and mandibular arches
Timepoint
[Time Frame: 0 days, 15 days, 1st month, 1.5 and 2nd month, 2.5 and 3rd month after start of treatment and conventional orthodontic]
Method of measurement
The amounts of OTM will be measured by comparing the changes of distance between the adjacent teeth in two weeks interval for three months. The exact amounts of tooth movement will be measured clinically by Boley Gauge Caliper with sharp tips located at the CEJ of crowns of the casts and then will be compared and double checked by another independent blind examiner ( to evaluate the interobserver and intraobserver reliability).