CTRI Number |
CTRI/2021/05/033657 [Registered on: 17/05/2021] Trial Registered Prospectively |
Last Modified On: |
13/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study used to determine in which among the two methods of fastest orthodontic tooth movement have more amount of root resorption |
Scientific Title of Study
|
"Comparative evaluation of root resorption during Piezocision induced and Platelet Rich Plasma (PRP) induced accelerated orthodontic tooth movement-A clinical study" |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR DEEPAK E R |
Designation |
POST GRADUATE STUDENT |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO: 06,
DEPARTMENT OF ORTHODONTICS,
COORG INSTITUTE OF DENTAL SCIENCES,
KK CAMPUS,
MAGGULA,
VIRAJPET,
KODAGU
Kodagu KARNATAKA 571218 India |
Phone |
8248727906 |
Fax |
|
Email |
dr.erdeepak@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR SANJU SOMAIAH |
Designation |
PROFESSOR |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO: 06,
DEPARTMENT OF ORTHODONTICS,
COORG INSTITUTE OF DENTAL SCIENCES,
KK CAMPUS,
MAGGULA,
VIRAJPET,
KODAGU
Kodagu KARNATAKA 571218 India |
Phone |
9945527999 |
Fax |
|
Email |
drsanjusomaiah@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
DR SANJU SOMAIAH |
Designation |
PROFESSOR |
Affiliation |
COORG INSTITUTE OF DENTAL SCIENCES |
Address |
ROOM NO: 06,
DEPARTMENT OF ORTHODONTICS,
COORG INSTITUTE OF DENTAL SCIENCES,
KK CAMPUS,
MAGGULA,
VIRAJPET,
KODAGU
Kodagu KARNATAKA 571218 India |
Phone |
9945527999 |
Fax |
|
Email |
drsanjusomaiah@yahoo.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
DR DEEPAK E R |
Address |
ROOM NO: 06,
DEPARTMENT OF ORTHODONTICS,
COORG INSTITUTE OF DENTAL SCIENCES,
KK CAMPUS,
MAGGULA,
VIRAJPET,
KODAGU - 571218. |
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 DEEPAK E R |
COORG INSTITUTE OF DENTAL SCIENCES |
ROOM NO: 06,
DEPARTMENT OF ORTHODONTICS,
COORG INSTITUTE OF DENTAL SCIENCES,
KK CAMPUS,
MAGGUAL,
VIRAJPET,
KODAGU
KARNATAKA - 571218 Kodagu KARNATAKA |
8248727906
dr.erdeepak@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: K088||Other specified disorders of teethand supporting structures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Normal orthodontic tooth movement |
In both group A and B, control side retraction done without any intervention |
Intervention |
Piezocision induced accrlerated orthoontic tooth movement |
In group A retraction will be started with piezocision on experimental and without piezocision on control side respectively. |
Intervention |
Platelet Rich Plasma (PRP) induced accelerated orthodontic tooth movement |
In group B retraction will be carried out with submucosal injection of PRP on experimental side and without PRP on the 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 |
1.Assess the rate of root resorption with Piezocision induced accelerated orthodontic tooth movement.
2.Assess the rate of root resorption with Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement.
|
1 month and 6 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Compare the rate of root resorption between Piezocision induced and Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement. |
1 month and 6 month |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
15/06/2021 |
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="6" 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 increased treatment time required for orthodontic therapy is one of the major causes for the increase in the risk of 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. 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 photomodulation and (c) pharmacological approach such as the injection of prostaglandin or relaxin. Keser and Dibart, introduced the Piezocision technique, a novel minimally invasive technique for accelerated tooth movement. 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. Hence the study is conducted to assess and compare the amount of root resorption in Piezocision and PRP induced accelerated tooth movement. Hence the need for the present study is to - 1.To assess the rate of root resorption with Piezocision induced accelerated orthodontic tooth movement. 2.To assess the rate of root resorption with Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement. 3.To compare the rate of root resorption between Piezocision induced and Platelet rich plasma (PRP) induced accelerated orthodontic tooth movement. 4.To draw the clinical inferences from above.
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