| CTRI Number |
CTRI/2021/08/035550 [Registered on: 10/08/2021] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of laser therapy with fluoride varnish and desensitizing toothpaste in the treatment of dentinal hypersensitivity. |
|
Scientific Title of Study
|
Comparative evaluation of low level laser therapy with fluoride varnish and desensitizing toothpaste in the treatment of dentinal hypersensitivity- A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susil Sekhar sahoo |
| Designation |
postgraduate student |
| Affiliation |
kalinga institute of dental sciences |
| Address |
campus 5 , kalinga institute of dental sciences, patia, bhubaneswar,
pin-751024
campus 5 , patia, bhubaneswar,
pin-751024
Khordha
ORISSA
751024
India |
| Phone |
9337296345 |
| Fax |
|
| Email |
drsusilsahoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangamesh N C |
| Designation |
Professor |
| Affiliation |
kalinga institute of dental sciences |
| Address |
campus 5 , kalinga institute of dental sciences, patia, bhubaneswar,
pin-751024
campus 5 , patia, bhubaneswar,
pin-751024
Khordha
ORISSA
751024
India |
| Phone |
8763784481 |
| Fax |
|
| Email |
sangamesh.chinnannavar@kids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susil Sekhar sahoo |
| Designation |
postgraduate student |
| Affiliation |
kalinga institute of dental sciences |
| Address |
campus 5 , kalinga institute of dental sciences, patia, bhubaneswar,
pin-751024
campus 5 , patia, bhubaneswar,
pin-751024
Khordha
ORISSA
751024
India |
| Phone |
9337296345 |
| Fax |
|
| Email |
drsusilsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral medicine and Radiology , Kalinga Institute of Dental Sciences , KIIT University . |
|
|
Primary Sponsor
|
| Name |
Dr susil sekhar sahoo |
| Address |
kainga institute of dental sciences, patia , bhubaneswar,
pin-751024 |
| 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 |
| Dr Susil Sekhar Sahoo |
Kalinga Institute of Dental Sciences |
campus-5, patia , bhubaneswar,
Khordha
ORISSA |
9337296345
drsusilsahoo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desensitizing toothpaste. |
positive control group. |
| Intervention |
Photobiomodulation. |
Low level laser therapy using 660 nm diode laser. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases of dentinal hypersensitivity, who have not taken any prior treatment for the same.
2.Minimum of two teeth having dentinal hypersensitivity with Schiff Cold Air Sensitivity Scale (SCASS) ≥ 2.
3.Patient willing to receive treatment for dentinal hypersensitivity. |
|
| ExclusionCriteria |
| Details |
Carious lesions.
Defective restorations.
Cracked tooth syndrome.
Use of medications such as sedatives, analgesics.
Developmental disorders.
Bruxism.
Habitual chewers.
Undergoing treatment for dentinal hypersensitivity.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected to decrease the dentinal hypersensitivity |
Baseline, 1 week, 2 weeks, 1 month, 3months, 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease the sensitivity with blocking the dentinal tubules. |
6 months. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
17/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
our study is completed |