| CTRI Number |
CTRI/2021/03/031874 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Study Aims at Comparison of two treatment modalities(LOW LEVEL LASER THERAPY AND MINI IMPLANT FACILITATED MICRO-OSTEOPERFORATIONS) for faster orthodontic movement of teeth which will decrease treatment time. |
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Scientific Title of Study
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“COMPARATIVE EVALUATION OF LOW LEVEL LASER THERAPY AND MINI IMPLANT FACILITATED MICRO-OSTEOPERFORATIONS ON THE RATE OF TOOTH MOVEMENT - A PROSPECTIVE CLINICAL STUDY†|
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Faraz Hasan |
| Designation |
post graduate |
| Affiliation |
Teerthankar Mahaveer Dental College and Research Centre |
| Address |
TMDCRC, Department of orthodontics and dentofacial orthopaedics,Bagadpur, New Delhi Road
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837547009 |
| Fax |
|
| Email |
farazunusual@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Goyal |
| Designation |
Principal, Professor and Head |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Teerthanker Mahaveer Dental College and Research Centre, NH24,
Delhi Road, Moradabad.
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
240001
India |
| Phone |
7009201137 |
| Fax |
|
| Email |
manishortho@yahoo.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Mukesh kumar |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Teerthanker Mahaveer Dental College and Research Centre, NH24,
Delhi Road, Moradabad.
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
240001
India |
| Phone |
9873453191 |
| Fax |
|
| Email |
drmukeshortho@yahoo.co.in |
|
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Source of Monetary or Material Support
|
| Department of orthodontic and dentofacial orthopaedics
Teerthankar mahaveer dental college and research centre |
|
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Primary Sponsor
|
| Name |
Faraz Hasan Self |
| Address |
Bagadpur, New Delhi road, Moradabad |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mukesh kumar |
1048, Sector C, Pocket 1, Vasant Kunj, New Delhi 110070 |
|
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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 |
| Faraz Hasan |
Teerthankar Mahaveer Dental College and Research Centre |
TMDCRC, Department of Orthodontics and Dentofacial Orthopaedics,Bagadpur, New Delhi Road
Moradabad
UTTAR PRADESH |
9837547009
farazunusual@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthankarmahaveerdentalcollegeandresearchcentre |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Low Level Laser Therapy |
Application of 810 nm wavelength low level laser after spring activation at 10 points, 10 seconds per point, for 4 consecutive days |
| Intervention |
Micro osteoperforation |
Three perforations at a gap of 3 mm at the extraction space with Mini implants.
|
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Angle’s Class II Div1 malocclusion (indicated for bilateral maxillary first premolar extraction) or Bimaxillary protrusion (indicated for all first premolar extraction).
2.All subjects with age group of 18 – 30 years.
3.All subjects undergoing treatment with Pre-adjusted Edgewise Appliance (PEA) with 0.022 MBT prescriptions.
4.Subjects who have completed the leveling and alignment (1st Phase). |
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| ExclusionCriteria |
| Details |
1.Previous history of orthodontic treatment.
2.Presence of craniofacial anomalies.
3.Presence of any signs and symptoms of gingival and periodontal diseases.
4.Long-term use of phenytoin sodium, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
5.Poor oral hygiene for more than 2 visits.
6.Severe skeletal Class II malocclusion, overjet more than 10 mm.
7.Systemic diseases.
8.Evidence of bone loss.
9.Past periodontal disease.
10.Smoking.
11.Gingivitis and caries
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary outcome to compare the tooth movement with low level laser therapy and modified micro osteoperforation in two different groups. |
Subjects will be evaluated at baseline, 3 weeks and 6 weeks later on his or her opd visits. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is to acess discomfort level in the patients during the treatment with Micro- osteoperforation using a numerical rating scale and to check analgesic effect of Low level laser therapy during orthodontic tooth movement. |
Subjects will be evaluated at baseline, 3 weeks and 6 weeks later on his or her opd visits. |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
11/03/2021 |
| Date of Study Completion (India) |
23/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This is an prospective clinical study to evaluate and compare the effect of modified micro-osteoperforations with low level laser therapy on the rate of tooth movement. The study will be conducted at Teerthankar Mahaveer Dental College And Research Centre on 20 patients age 18- 30 years having Class II division I or Bimaxillary Protrusion malocclusion pattern from Dept. of Orthodontics and Dentofacial Orthopaedics. The study will be a comparative clinical trial conducted from the beginning of 2nd Phase (space closure phase) of fixed orthodontic treatment, for duration of 6 weeks
To check movement of tooth digital scan of the patient will be done with the help of intra oral scanner before and after canine retraction, the patients will be equally and randomly divided into 2 groups: Group1 in which LLT will be randomly assigned to one side of the maxillary arch (experimental side), and a Group 2 in which MOPs will be randomly assigned to one side of the maxillary arch (experimental side). Randomization will be performed with coin tosses to prevent selection bias. The sides contralateral to the procedures will serve as the controls in both groups. Secondary outcome to assess the pain and discomfort level in the patients during the treatment with Micro-osteoperforation using a numerical rating scale and to check analgesic effect of LLLT during orthodontic tooth movement.
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