| CTRI Number |
CTRI/2023/02/049793 [Registered on: 16/02/2023] Trial Registered Prospectively |
| Last Modified On: |
03/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
treatment of dentinal hypersensitivity with laser |
|
Scientific Title of Study
|
“Comparative Evaluation of the Effects of Treatment of Dentinal Hypersensitivity with Diode Laser of Two Wavelengths (980 nm and 650 nm– A Split Mouth In Vivo Study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kasturi Satam |
| Designation |
Postgraduate student |
| Affiliation |
Nair hospital dental college |
| Address |
Department of Periodontics, Nair hospital dental college, Opposite maratha mandir,
Mumbai central,
Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9920940714 |
| Fax |
|
| Email |
kasturisatam18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Head of Department |
| Affiliation |
Nair hospital dental college |
| Address |
Department of Periodontics, Nair hospital dental college, Opposite maratha mandir,
Mumbai central,
Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kasturi Satam |
| Designation |
Postgraduate student |
| Affiliation |
Nair hospital dental college |
| Address |
Department of Periodontics, Nair hospital dental college, Opposite maratha mandir,
Mumbai central,
Mumbai 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9920940714 |
| Fax |
|
| Email |
kasturisatam18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nair Hospital dental college Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Kasturi Satam |
| Address |
Nair dental college and hospital
Mumbai |
| 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 Kasturi satam |
Nair hospital dental college |
Room no 201, Department of Periodontics,
Nair hospital dental college
Opposite maratha mandir
Mumbai central
Mumbai 400008
Mumbai
MAHARASHTRA |
9920940714
kasturisatam18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics commitee NHDC |
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 |
| Intervention |
diode laser test group 1 |
diode laser 980 nm
single application |
| Intervention |
diode laser test group 2 |
diode laser 650 nm
single application |
| Comparator Agent |
fluoride varnish |
positive control
single application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who experienced sensitivity
after oral prophylaxis. |
|
| ExclusionCriteria |
| Details |
1.Patients using desensitizing toothpaste
during the last 3 months
2.Patients on NSAIDs
3.Patients who had undergone bleaching
treatment in the past.
4.Pregnant or breast-feeding women
5.Teeth with caries, restorations, pulpitis,
congenital anomalies, cracks, and
occlusal interferences |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| dentinal hypersensitivity compared on visual analog scale |
pretreatment
immediately after treatment
one week posttreatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dentinal hypersensitivity compared on schiffs sensitivity score |
pretreatment
immediately after treatment
one week posttreatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/02/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Split mouth design divided into three groups: 1)Treated with fluoride varnish : Positive control 2)980 nm laser irradiation as test group 1 3) 650 nm laser irradiation as test group 2
METHODS OF MEASUREMENT
Pain is to be assessed on 1) A Visual analog 10-interval scale ranging
from 0 to 10, with 10 representing the maximum
pain. 2) Four-point Schiff Sensitivity Scale
Statistical analysis:
Data collected will be compiled on to a MS
Office excel worksheet & will be subjected to
statistical analysis using an appropriate package
like SPSS software. |