| CTRI Number |
CTRI/2017/05/008547 [Registered on: 12/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
use of diode laser and calcium sodium phosphosilicate for the treatment of dentinal hypersensitivity of tooth - a short term randomized clincial trial |
|
Scientific Title of Study
|
Diode Lasers : A Virtuous Desensitizer |
| Trial Acronym |
DLDS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aratrika Mukherjee |
| Designation |
Post Graduate student |
| Affiliation |
Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan |
| Address |
room no. 5, department of periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9564593213 |
| Fax |
|
| Email |
draratrika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aratrika Mukherjee |
| Designation |
Post Graduate student |
| Affiliation |
Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan |
| Address |
Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan
KARNATAKA
573201
India |
| Phone |
9564593213 |
| Fax |
|
| Email |
draratrika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aratrika Mukherjee |
| Designation |
Post Graduate student |
| Affiliation |
Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan |
| Address |
room no. 5, department of periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9564593213 |
| Fax |
|
| Email |
draratrika@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no. 5, department of periodontics,Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan -573202, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
department of periodontics |
| Address |
Sri Hasanamba Dental College and Hospital, Vidyanagar, Hassan- 573201, Karnataka, India |
| Type of Sponsor |
Other [private dental college and hospital] |
|
|
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 |
| Aratrika Mukherjee |
sri hasanamba dental college and hospital |
Room no. 5 , Department of Periodontics,
Hassan
KARNATAKA |
9564593213
draratrika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional scientific review comittee, sri hasanamba dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients reporting to the department with the chief complaint of dentinal hypersensitivity of the tooth were taken, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
calcium sodium phosphosilicate and diode laser |
the intervention in this randomized clinical study is diode laser and the comparator agent is calcium sodium phosphosilcate toothpaste.
All the enrolled patients underwent ultrasonic scaling with proper oral hygiene instructions prior to the desensitizing treatment. Then they were randomly allocated into three groups by chit picking method:
A – lased with diode laser ( Photon plus diode laser, Zolar technologies and Mfg Co. Inc,
Mississauga On, Canada, 980 nm) 0.5W in power, non contact mode, of 3 applications of 1
minute each for 3 consecutive days.
B – treated with Calcium Sodium Phosphosilicate which was applied for 60s over the tooth surface and then irradiated with
3 applications of diode laser of 1 minute each for 3 days.
C – treated only with Calcium sodium phosphosilicate for 60s for 3 days.
|
| Intervention |
Diode laser |
Group A – lased with diode laser ( Photon plus diode laser, Zolar technologies and Mfg Co. Inc, Mississauga On, Canada, 980 nm) 0.5W in power, non contact mode, of 3 applications of 1 minute each for 3 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
presence of atleast two sensitive permanent teeth surfaces (buccal/ facial aspects), presence of wasting disease of teeth or gingival recession, no history of periodontal treatment in the past one year. |
|
| ExclusionCriteria |
| Details |
presence of any systemic conditions, chronic or recent use of anti-inflammatory and analgesic drugs, eating disorder, previous treatment for dentinal hypersensitivity, pregnancy and lactation, allergies or hypersensitivity to desensitizing agents. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction of NRS(Numerical Rating Scale) in which group after the use of the laser alone,laser and calcium sodium phosphosilicate and calcium sodium phosphosilicate alone. |
reduction of NRS(Numerical Rating Scale) was recorded in all the groups at baseline and before the treatment session for 3 consecutive days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| whether air stimulus or tactile stimuls was more effected reducing the NRS score |
the scoring was compared from baseline to 3 days after the treatment |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/01/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dentinal hypersensitivity
(DH) is an abnormal response of the exposed vital dentine to thermal, chemical,
or tactile stimuli. The prevalence of hypersensitivity has been reported
ranging from 4% to 57% in the literature. So this study was aimed to compare
the immediate effectiveness of diode laser alone and with topical calcium
sodium phosphosilicate(CSPS). Three groups were taken
with 15 samples in each. Group A was treated with diode laser alone, Group B
with diode laser and CSPS and Group C was given only topical CSPS. The 3 groups
were assessed by air and tactile stimuli measured by Numerical Rating Scale
before and after every treatment session for a total of 3 treatment sessions
for 3 consecutive days. |