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CTRI Number  CTRI/2020/05/025252 [Registered on: 20/05/2020] Trial Registered Prospectively
Last Modified On: 11/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   COMPARISON OF RATE OF TOOTH MOVEMENT USING MINIMALLY INVASIVE PROCEDURE OF MICRO-OSTEOPERFORATION AND PIEZOCISION WITHOUT RAISING FLAP FOLLOWED BY LOW LEVEL LASER THERAPY IN UPPER JAW - A RANDOMISED CLINICAL TRIAL 
Scientific Title of Study   COMPARISON OF RATE OF TOOTH MOVEMENT DURING INDIVIDUAL CANINE RETRACTION USING FLAPLESS MICRO-OSTEOPERFORATION AND PIEZOCISION ASSISTED BY LOW LEVEL LASER THERAPY - A RANDOMISED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AARTI ANANT SETHIA 
Designation  POST-GRADUATE STUDENT IN ORTHODONTICS 
Affiliation  KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, BELAGAVI 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, JNMC CAMPUS, NEHRU NAGAR, BELAGAVI

Belgaum
KARNATAKA
590010
India 
Phone  9769590851  
Fax    
Email  aarti2701@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANAND BADAVANNAVAR 
Designation  READER IN DEPARTMENT OF ORTHODONTICS 
Affiliation  KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, BELAGAVI 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, JNMC CAMPUS, NEHRU NAGAR, BELAGAVI

Belgaum
KARNATAKA
590010
India 
Phone  9845857686  
Fax    
Email  anand_ortho@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  AARTI ANANT SETHIA 
Designation  POST-GRADUATE STUDENT IN ORTHODONTICS 
Affiliation  KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, BELAGAVI 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, JNMC CAMPUS, NEHRU NAGAR, BELAGAVI

Belgaum
KARNATAKA
590010
India 
Phone  9769590851  
Fax    
Email  aarti2701@gmail.com  
 
Source of Monetary or Material Support  
KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES ,BELAGAVI 
 
Primary Sponsor  
Name  AARTI ANANT SETHIA 
Address  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, JNMC CAMPUS, NEHRU NAGAR, BELAGAVI 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
ANAND BADAVANNAVAR  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS, KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, JNMC CAMPUS, NEHRU NAGAR, BELAGAVI 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AARTI ANANT SETHIA  KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES  DEPARTMENT NO-8 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS
Belgaum
KARNATAKA 
9769590851

aarti2701@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE UNIVERSITY -Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PATIENTS UNDERGOING ORTHODONTIC TREATMENT WITHOUT ANY MEDICAL CONDITIONS WITH GOOD PERIODONTAL AND GINGIVAL STATUS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MICRO-OSTEOPERFORATION ASSISSTED BY LOW LEVEL LASER THERAPY  CRETING THREE PERFORATIONS IN THE EXTRACTION SITE ONLY ONCE USING STANDARDIZED CUSTOMISED STENT FOLLOWED BY ANALGESIC (THREE DOSE) AND HEALING PROTOCOL OF LASER (SIX DOSE)IN TOTAL 2 MONTHS DURATION LASER IS USED FOR 150 SEC ON EACH SIDE 
Comparator Agent  PIEZOCISION ASSISSTED BY LOW LEVEL LASER THERAPY  A CORTICOTOMY CUT WITHOUT RAISING FLAP IN THE EXTRACTION SITE ONCE USING STANDARDIZED CUSTOMISED STENT FOLLOWED BY ANALGESIC(THREE DOSES) AND HEALING PROTOCOL(SIX DOSE) OF LASER 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Both male and female patients in the age group of 16-35 years.
2.Subjects requiring right and left upper first premolar extraction followed by bilateral canine retraction as a part of orthodontic treatment.
3.Probing depth values not exceeding 3mm across the entire dentition.
4.Adequate thickness of the attached gingiva (1-2mm)
5.No radiographic evidence of bone loss.

 
 
ExclusionCriteria 
Details  1.History of previous orthodontic treatment.
2.Periodontally compromised patients.
3.Medically compromised patients or patients with systemic disease that might have affected bone formation or density such as osteoporosis, hyperparathyroidism or vitamin D deficiency.
4.Patients on any kind of long term medication.
5.Subjects indicated for extraction of any tooth other than first premolars for orthodontic treatment.
5.Patients with unilateral chewing/ parafunctional habits, crossbites and occlusal interferences.
6.Impacted canine or canine with dilacerated roots.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
TO COMPARE BETTER CHOICE OF METHOD FOR ACCELERATING TOOTH MOVEMENT WITH AN ADDITIONAL ADJUNCT LOW LEVEL LASER THERAPY  Assessment:0 day
after 1 month
after 2 month

laser dosage
pre-surgical laser dose
immediately after the procedure of micro-osteoperforation and piezocision
day3,4,5 -Analgesic protocol of laser
day-7,14,28,56-Healing protocol of laser 
 
Secondary Outcome  
Outcome  TimePoints 
TO COMPARE BETTER CHOICE OF METHOD FOR ACCELERATING TOOTH MOVEMENT WITH AN ADDITIONAL ADJUNCT LOW LEVEL LASER THERAPY  Assessment:0 day
after 1 month
after 2 month

laser dosage
pre-surgical laser dose
immediately after the procedure of micro-osteoperforation and piezocision
day3,4,5 -Analgesic protocol of laser
day-7,14,28,56-Healing protocol of laser 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   Phase 1 
Date of First Enrollment (India)   21/05/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Jean-David MS, SURMENIAN J, DIBART S. Accelerated orthodontic treatments with Piezocision: a mini–invasive alternative to alveolar corticotomies. Orthod Fr. 2011;82:311-9. Alikhani M, Alansari S, Sangsuwon C, Alikhani M, Chou MY, Alyami B, Nervina JM, Teixeira CC. Micro-osteoperforations: minimally invasive accelerated tooth movement. InSeminars in Orthodontics 2015 Sep 1 (Vol. 21, No. 3, pp. 162-169). WB Saunders.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

An increasing number of patients are demanding orthodontic treatment for improved aesthetics as it affects their professional and social life. But one of the main challenges of orthodontic treatment faced by the patients and the orthodontists is the prolonged treatment duration. Long duration of fixed orthodontic treatment, which usually lasts for 2-3 years, is accompanied by side effects such as root resorption, gingival inflammation and dental caries.1  For rapid canine retraction ,various researchers proposed different surgical techniques such as dentoalveolar distraction-based on principles of distraction osteogenesis, selective alveolar decortication etc.3 But all these surgical procedures lead to increase risk of  tissue necrosis. Later to identify minimally invasive surgical procedures for inducing RAP researchers have introduced micro-osteoperforation, to Control the micro-trauma micro-osteoperforations (MOP) will amplify the expression of inflammatory markers that are normally expressed during orthodontic treatment and that this amplified response will accelerate both bone resorption and tooth movement.5 Recently kim et al and Dibart et al introduced a minimally invasive technique , piezocision as an alternative to the highly invasive surgical techniques which involves the use of scalpel into the gingiva  without raising the flap and further placement of incisions using an ultrasonic tool.1Low-level visible red or infrared light energy is absorbed by mitochondria, which stimulates cells to generate more energy in the form of ATP and help undergo self-repair through cell proliferation, release of growth factors and collagen synthesis. This phenomenon is also known as Photobiomodulation (PBM) therapy.With regards to orthodontic tooth movement, the effects of the LLLT on osteoblasts, osteoclasts and fibroblasts are of more interest. LLLT shows a biostimulatory effect on osteoblasts with an increase in their differentiation, DNA replication and bone matrix production. Also, LLLT facilitated that LLLT facilitated differentiation and activation of osteoclasts via RANK expression and stimulation of expression of Macrophage colony-stimulating factor (M-CSF) and its receptor system. 


 
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