| CTRI Number |
CTRI/2023/10/058291 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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TO OBSERVE THE EFFECT OF LOW LEVEL LASER THERAPY ON APICAL ROOT RESORPTION OCCURING DURING ORTHODONTIC TREATMENT AT THE STAGE OF MAXILLARY CANINE RETRACTION USING THE ARCH WIRES NANO COATED WITH PARYLENE.RANDOMIZED CONTROLLED TRIAL AND CBCT STUDY.
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Scientific Title of Study
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EVALUATING THE EFFECT OF APPLICATION OF LOW-LEVEL LASER THERAPY (LLLT) ON APICAL ROOT RESORPTION DURING MAXILLARY CANINE RETRACTION BY SLIDING MECHANICS EMPLOYING ARCH WIRES NANO COATED WITH PARYLENE:
A SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL, CBCT STUDY.
|
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prajakta Joshi |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur. |
| Address |
Department of orthodontics and dentofacial orthopedics, Swargiya
Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna,
Nagpur.
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
|
| Fax |
|
| Email |
prajaktajoshi0825@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Jawalekar |
| Designation |
HOD and Professor ,guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur. |
| Address |
Department of orthodontics and dentofacial orthopedics, Swargiya
Dadasaheb Kalmegh Smruti Dental College and Hospital,
441110
India Hingna,
Nagpur.
Nagpur
MAHARASHTRA
Department of orthodontics and dentofacial orthopedics, Swargiya
Dadasaheb Kalmegh Smruti Dental College and Hospital,
441110
India Hingna,
Nagpur.
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9923344855 |
| Fax |
|
| Email |
rashmi.jawlekar@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Joshi |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna, Nagpur. |
| Address |
Department of orthodontics and dentofacial orthopedics, Swargiya
Dadasaheb Kalmegh Smruti Dental College and Hospital, Hingna,
Nagpur.
Nagpur
MAHARASHTRA
441110
India
MAHARASHTRA
441110
India |
| Phone |
|
| Fax |
|
| Email |
prajaktajoshi0825@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics,Swargiya Dadasaheb Kalmegh Smruti
Dental College and Hospital, Hingna, Nagpur. |
|
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Primary Sponsor
|
| Name |
Dr.Prajakta Joshi |
| Address |
PIONEER WOODS E WING 402 , WANADONGARI, NAGPUR |
| Type of Sponsor |
Other [SELF FUNDED] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prajakta Joshi |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital , Hingna, Nagpur, Maharashtra. |
Department of
Orthodontics and
Dentofacial Orthopedics
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
8208602611
prajaktajoshi0825@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SWARGIYA DADASAHEB KALMEGH SMRUTI DENTAL COLLEGE AND HOSPITAL, WANADONGARI ROAD, HINGANA, NAGPUR, 441110 |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K033||Pathological resorption of teeth, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Canine retraction without low level laser therapy. |
canine retraction using sliding mechanics. |
| Intervention |
low-level laser therapy |
AMD laser:
Picasso R Plus & Picasso R Lite Plus (also referred to as Picasso+ and Picasso Lite+ herein) employ solid-state diodes as a laser energy source.
WAVELENGTH: Near infrared light (810 nm)
POWER: 1.5W
TIMER:10 sec.
The energy is delivered to the operating area by means of a delivery system consisting of a flexible fibre connecting the laser source and the handpiece. The device is activated by means of a wireless footswitch.
6. During canine retraction, diode laser will be used on experimental side for 10 secs per site. One irradiation will be done on the middle third of the canine root on the buccal side, and second on the palatal side holding the laser tip very close to the mucosa but not in contact to avoid contamination and tissue damage. Laser will be used with interval of 0, 3, 7, 14 days and then once every month till retraction is completed on experimental side. Other side of same maxillary arch will be considered as control side. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
1) Permanent dentition including right and left second molars in both the arches.
2) The patient with completed levelling and alignment, requiring Orthodontic treatment with first premolar extraction and ready to retract maxillary canines.
3) Good oral hygiene. |
|
| ExclusionCriteria |
| Details |
1) Any medical or dental condition that, in the opinion of the investigator, could negatively affect study results during the expected length of the study.
2) Currently using any investigational drug or any other investigational device.
3) Planning to relocate or move during the treatment period.
4) Allergic to acetaminophen (use of aspirin or nonsteroidal anti-inflammatory drugs is excluded for patients while on the study).
5) Use of bisphosphonates (osteoporosis drugs) during the study.
6) Pregnancy.
7) Smokers. |
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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Alternation |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Application of low-level laser therapy (LLLT) may reduce the apical root resorption during maxillary canine retraction by sliding mechanics employing arch wires nano coated with Parylene. |
6 months |
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Secondary Outcome
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| Outcome |
TimePoints |
| Parylene nano coated arch wires with & without application of low-level laser therapy may speed up the Orthodontic treatment. |
6 months |
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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" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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="1"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Orthodontic treatment aims in establishing, aesthetic, stable and functional occlusion. Duration of the Orthodontic corrections ranges between 12-30 months according to severity of malocclusion, compliance of the patient and other factors.1 Due to longer duration for Orthodontic corrections, patient is apprehensive about Orthodontic treatment and tends to avoid treatment. Review of literature shows that, the root resorption is related to time and force employed during orthodontic treatment. Longer the treatment time, greater is the chance for root resorption, caries, and decreased patient compliance.2 Reducing the treatment duration of Orthodontic corrections is the greatest challenge faced by every Orthodontist. Various treatment modalities suggested for accelerating tooth movement are injections of prostaglandin, 1,25(OH)2D3 (active form of vitamin D3); Parathyroid hormone, Osteocalcin and Relaxin. Electric stimulation; surgical methods (corticotomy, piezo-surgery) mechanical / physical methods (vibrations, lasers/Photo-biomodulation) and use of magnets are also reported for accelerating tooth movements.3,4 Out of various techniques suggested for accelerating tooth movement, application of low-level laser therapy (LLLT) is one of the convenient and non-invasive technique. In addition to reducing the treatment duration, it also reduces the intensity of pain associated with Orthodontic corrections and has healing effects on periodontium.5 Orthodontic forces lead to cellular response in periodontal ligament in the form of bone resorption on pressure side and bone deposition on tension side.This happens via RANK-RANKL-OPG pathway and inflammatory mediators like IL-1, IL-8, TNF-α.3 Low intensity lasers stimulate the dentoalveolar complex; induce wound healing by fibroblast and chondral proliferation; collagen synthesis, and nerve regeneration.6 It impacts on ATP production by mitochondria. Light accelerated orthodontics (LAO) increases ATP production at localized site which stimulates osteoblastic cellular proliferation and differentiation leading to increase in bone re-modelling procedure and thus accelerate the tooth movement. 1 Low intensity lasers induce osteoclastogenesis by inducing RANK/RANKL pathway which induces signaling molecules such as MAPK (Mitogen activated protein kinase), c-fos and nitric oxide. This helps in reduction of relapse, pain and root resorption due to orthodontic forces.3,4 Orthodontic appliances are exposed to saliva flow, food, temperature, and appliance force in oral cavity which leads to bio-corrosion, changes in microstructure, surface topography, mechanical properties and leaching of ions. Overcoming frictional resistance between the bracket and wires and then bringing tooth movement requires higher force values. Study of literature shows that nanocoating of wires with different nanoparticles reduces the frictional resistance thereby reducing the orthodontic force needed for tooth movement.7 Coating techniques and modifications of arch wire composition can control leaching of ions, eliminate friction and bacterial adhesion and thus accelerate orthodontic tooth movement.8 The anchorage loss also can be controlled by frictionless mechanism. Root resorption in Orthodontics is an undesired feature during Orthodontic corrections and is directly related to amount of force applied for Orthodontic corrections. Invention in field of nano-coatings have offered the field of Orthodontics its greatest advantage in reducing the friction. One of the nanoparticles, Parylene coatings have advantages like: It is highly resistant to corrosive conditions of body fluids, it is bio- compatible, has dry film lubricity, ability to form a thin continuous pinhole free inert film, low density, high dielectric barrier, and has proper thermal and UV stability.Judicious application of incorporating the advantages of gaining accelerated tooth movement with better comfort to the patient, without root resorption would be a dream come true in Orthodontic practice. Review of literature does not report about any studies showing effect of Parylene coating and use of LLLT in accelerating Orthodontics treatment. The present study aims at evaluating the effect of application of low-level laser therapy (LLLT) on apical root resorption during maxillary canine retraction by sliding mechanics employing arch wires nano coated with parylene to obtain accelerated tooth movement with more comfort to patient and with minimal root resorption. |