| CTRI Number |
CTRI/2024/10/075767 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of the effect of low level laser therapy in correction of mandibular anterior crowding |
|
Scientific Title of Study
|
Assessment of the effect of low level laser therapy in correction of mandibular anterior crowding - A randomised controlled trail |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharanya P |
| Designation |
Post graduate student |
| Affiliation |
KVG Dental college and Hospital, kurunjibagh, sullia |
| Address |
KVG Dental college and Hospital, Department of Orthodontics and Dentofacial Orthopaedics,Room No-7, Kurunjibagh, Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8904053131 |
| Fax |
|
| Email |
dr.sharanya201996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh kumar Y |
| Designation |
Professor |
| Affiliation |
KVG Dental college and Hospital, kurunjibagh, sullia |
| Address |
KVG Dental college and Hospital, Department of Orthodontics and Dentofacial Orthopaedics, Room No- 7 ,Kurunjibagh, Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh kumar Y |
| Designation |
Professor |
| Affiliation |
KVG Dental college and Hospital, kurunjibagh, sullia |
| Address |
KVG Dental college and Hospital, Department of Orthodontics and Dentofacial Orthopaedics, Room No-7,Kurunjibagh, Sullia
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448128842 |
| Fax |
|
| Email |
ymahesh2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| K.V.G Dental college and Hospital, kurunjibagh, sullia, Dakshina Kannada, 574327, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
DrSharanyaP |
| Address |
KVG Dental College and Hospital, kurunjibagh, sullia |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrSharanyaP |
KVG Dental college |
Department of Orthodontics and Dentofacial Orthopaedics, Room No-7, Kurunjibagh, Sullia, Dakshina Kannada
Dakshina Kannada
KARNATAKA |
8904053131
dr.sharanya201996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional orthodontic alignment of mandibular crowding |
conventional orthodontic alignment of mandibular crowding teeth over a period of 6months |
| Intervention |
Low Level Laser Therapy |
Low level laser therapy irradiation will be performed by keeping the optical fiber tip perpendicular and in direct light contact with the mucosa on the labial sides, mesial and distal to the apical area, mesial and distal to the cervical area, and 1 point approximately at the middle of the root of each mandibular incisor teeth |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Presence of all mandibular permanent teeth except third molars
2.Moderate crowding in the anterior mandible with littles irregularity index of 7mm or more-indicating extraction of two first premolars
3.No previous orthodontic treatment
4.No systemic diseases
5.Good oral hygiene |
|
| ExclusionCriteria |
| Details |
1.History of trauma
2.History of orthodontic treatment
3.Decayed permanent teeth
4.Patients who have previous history of systemic diseases
5.Patients with congenitally missing anterior
6.Patients with severe tooth displacement
7.Longterm use of systemic corticosteroids, calcium channel blockers and anti-inflammatory |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the time taken for correction of mandibular anterior crowding with low level laser therapy |
baseline, 1month, 2month,3month,4month,5month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the time taken for correction of mandibular anterior crowding without low level laser therapy |
6months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 2 |
|
Date of First Enrollment (India)
|
02/11/2024 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
Low level laser therapy using Gallium-Aluminum-Arsenic Diode laser with wavelength of 980nm will be irradiated for 5 sec at each points on the labial sides, mesial and distal to apical area ,mesial and distal to cervical area and one point approximately at the middle of the root of each six mandibular incisor teeth during levelling and alignment which will be compared with conventional method without laser therapy to estimate time taken for the correction of mandibular anterior crowding. |