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
|
|
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.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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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