CTRI Number |
CTRI/2023/05/052211 [Registered on: 02/05/2023] Trial Registered Prospectively |
Last Modified On: |
28/04/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
COMPARAING THE SPEED OF TOOTH MOVEMENT IN TWO TYPES OF FASTEN TOOTH MOVEMENTS. |
Scientific Title of Study
|
COMPARATIVE EVALUATION BETWEEN PLATELET RICH PLASMA (PRP) AND PIEZOCISION ASSISTED RATE OF RETRACTION IN BIMAXILLARY PROTRUSION CASES - A CLINICAL STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR POOJA SHARMA |
Designation |
POST GRADUATE STUDENT |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET
Kodagu KARNATAKA 571218 India |
Phone |
9008601770 |
Fax |
|
Email |
pooja1stapril@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR GOUTHAM B |
Designation |
PROFESSOR AND HOD |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET
Kodagu KARNATAKA 571218 India |
Phone |
9900620536 |
Fax |
|
Email |
drgouthamreddy2000@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR GOUTHAM B |
Designation |
PROFESSOR AND HOD |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET
Kodagu KARNATAKA 571218 India |
Phone |
9900620536 |
Fax |
|
Email |
drgouthamreddy2000@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DR POOJA SHARMA |
Address |
ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET |
Type of Sponsor |
Other [SELF ] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR POOJA SHARMA |
COORG INSTITUTE OF DENTAL SCIENCES |
ROOM NO 6, DEPATRMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS, CIDS, KK CAMPUS , MAGGULA, VIRAJPET Kodagu KARNATAKA |
9008601770
pooja1stapril@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
COORG INSTITUTE OF DENTAL SCIENCES |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
RATE OF RETARCTION IN PRP |
In group B retraction will be carried out with submucosal injection of PRP on experimental side and without PRP on the control side. |
Comparator Agent |
RATE OF RETRACTION IN CONTROL |
In both group A and B control side retraction will be done without any intervention |
Intervention |
RATE OF RETRACTION IN PIEZOCISION |
In group A retraction will be started with piezocision on experimental and without piezocision on control side |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
1.Angle’s class I malocclusion indicated for bilateral maxillary first premolar extraction.
2.Male and female patients between the age group of 18 and 45 years.
3.Patients with no clinical signs of periodontal diseases.
4.Patients with no gingivitis or untreated caries
5.Patients with no history of periodontal therapy.
|
|
ExclusionCriteria |
Details |
1.Previous history of any orthodontic or orthopedic treatment
2.Any bone pathology, ankylosed teeth.
3.Patients taking drugs modifying normal bone physiology (i.e., bisphosphonates) on or before a period of 3 months.
4.Long term use of anti-biotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids and calcium channel blockers.
5.Smokers
6.Patients with evidence of bone loss.
7.Patient having a pacemaker or any other active implant.
8.Patients who have undergone periodontal treatment within three months of baseline examination.
9.Systemic disorder that could influence periodontal health.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
•To assess the rate of enmasse retraction with Piezocision induced accelerated orthodontic tooth movement in bimaxillary protrusion cases.
•To assess the rate of enmasse retraction with Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement in bimaxillary protrusion cases.
|
T0 - Beginning of enmasse retraction
T1 - After 90 days of enmasse retraction.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
• To compare the rate of enmasse retraction between Piezocision induced and Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement in bimaxillary protrusion cases. |
T0 - Beginning of enmasse retraction
T1 - After 90 days of enmasse retraction.
|
|
Target Sample Size
|
Total Sample Size="16" Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
05/06/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The long duration of orthodontic
treatment is one of the most frequent complaints of orthodontic patients.
It results from the use of traditional mechanical forces to induce movement by
stimulation of resorption modelling in the paradental tissue (1). Long term orthodontic treatment causes increase in
the risk of dental caries, gingival recession and root resorption. Shorter
duration of orthodontic treatment is the need of the hour in current practice
as huge number of adult patients demand results within a short span of time. As
a result, there is an increased number of studies focusing on methods that
accelerate orthodontic tooth movement. Several noninvasive or invasive
techniques have been proposed clinically or experimentally for accelerating
orthodontic tooth movement (2). The noninvasive
techniques include (a) biomechanical approach such as the self-ligation
brackets (b) physiological approach such as the direct electric current
stimulation, the low-level laser therapy, vibration or photo modulation and (c)
pharmacological approach such as the injection of prostaglandin or relaxin (3).
Keser and Dibart, introduced the Piezocision technique, a novel minimally
invasive technique for accelerated tooth movement (4). One of the recently used
local agents to accelerate the rate of orthodontic tooth movement is
platelet-rich plasma (PRP). PRP is defined as an autologous concentration of
platelets in a minute volume of plasma.
Through this study, we will be assessing
and comparing the rate of enmasse retraction between Piezocision and Platelet-rich plasma (PRP) induced
accelerated tooth movement in bimaxillary protrusion cases. |