| CTRI Number |
CTRI/2024/10/075802 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to check the combined effect of low energy laser therapy and micro-osteoperforation on the rate of orthodontic tooth movement: a split mouth randomized clinical trial |
|
Scientific Title of Study
|
combined effect of photobiomodulation using low energy laser therapy and micro-osteoperforation on the rate of orthodontic tooth movement: a split mouth randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhay Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences (RIMS), RANCHI, JHARKHAND |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Dental Instutute
Rajendra Institute of Medical Sciences(RIMS), RANCHI, JHARKHAND
Ranchi
JHARKHAND
834009
India |
| Phone |
9897063692 |
| Fax |
|
| Email |
docabhayjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhay Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences (RIMS), RANCHI, JHARKHAND |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Dental Instutute
Rajendra Institute of Medical Sciences(RIMS), RANCHI, JHARKHAND
Ranchi
JHARKHAND
834009
India |
| Phone |
9897063692 |
| Fax |
|
| Email |
docabhayjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhay Kumar Jain |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences (RIMS), RANCHI, JHARKHAND |
| Address |
Department of Orthodontics and Dentofacial Orthopedics
Dental Instutute
Rajendra Institute of Medical Sciences(RIMS), RANCHI, JHARKHAND
Ranchi
JHARKHAND
834009
India |
| Phone |
9897063692 |
| Fax |
|
| Email |
docabhayjain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Rajendra Institute of Medical Sciences (RIMS), Dental Institute, Ranchi Jharkhand-834009 |
|
|
Primary Sponsor
|
| Name |
Abhay Kumar Jain |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Rajendra Institute of Medical Sciences (RIMS), Dental Institute, Ranchi Jharkhand-834009 |
| 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 |
| Abhay Kumar Jain |
Rajendra Institute of Medical Sciences (RIMS) |
Department of Orthodontics and Dentofacial Orthopedics, RIMS, Dental Institute, Ranchi 834009
Ranchi
JHARKHAND |
9897063692
docabhayjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gingival perforation |
on the other side of the split mouth model no treatment will be done and retraction will be done after giving gingival perforation on the mucosa without touching the bone |
| Intervention |
Low level laser therapy and micro-osteoperforation |
Diode laser emitting infrared radiation at 980 nm, with an output power of 100 mW, dose of 10
J/cm2 operating in a continuous-wave mode will be used to deliver low-level laser therapy folllowed by micro-osteoperforation using mini-implant in the extraction space immediately after canine retraction. |
|
|
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 Class I Bimaxillary protrusion (indicated 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 (1 st Phase).
5. No systemic disease.
6. No radiographic evidence of bone loss.
7. No history of periodontal disease.
8. No current active periodontal disease.
9. No smoking.
10. No gingivitis or untreated caries. |
|
| 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. Systemic diseases
7. Evidence of bone loss
8. Past periodontal disease
9. Smoking
10. Gingivitis and caries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the effect micro-osteoperfoation and low levell laser therapy on the rate of tooth movement |
at baseline, 21st day, 42nd day, 63rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the pain perception related to procedure. |
to assess their
level of discomfort on the day of canine retraction, and subsequently at 1 hour, 24 hours, 72
hours, 7 days, and 28 days |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
05/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Data will be available in published article
- For how long will this data be available start date provided 01-06-2026 and end date provided 31-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of the present study is to evaluate the combined effect of Micro-osteoperforation (MOP) combined with Low level laser therapy over 9 weeks period (63 days) on the rate of orthodontic tooth movement. This is a single center, split mouth, parallel-arm, randomized controlled clinical trial performed with 1:1 allocation ratio. Primary goal will be to evaluate the effect of modified micro-osteoperforations combined with Low Level Laser Therapy (LLLT) on the rate of orthodontic tooth movement. Secondary goal will be to assess the pain and discomfort level in the patients during the treatment using a visual analogue scale. The null hypothesis will be that combined effect of MOP + LLLT does not accelerate the rate of tooth movement compared to their matched control. MOP and LLLT will be given on one side and gingival perforations will be done on the other side of the split mouth model. This will be done in the extraction space immediately after commencement of canine retraction and the measurement will be done on dental casts using digital vernier callipers. |