| CTRI Number |
CTRI/2024/11/077388 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Action of Whiteness HP Maxx bleaching agent when used with and without 445nm Diode Laser |
|
Scientific Title of Study
|
A comparative evaluation of the effect and efficacy of Whiteness HP Maxx with and without 445nm Diode Laser - A Split mouth study |
| 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 Priyankar Roy |
| Designation |
Postgraduate Student |
| Affiliation |
KAHER KLE Vishwanath Katti Institute Of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Science,JNMC
Campus,Nehru Nagar,Belgaum Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Science,JNMC
Campus,Nehru Nagar,Belgaum Belgaum KARNATAKA 590010 India |
| Phone |
9535428250 |
| Fax |
|
| Email |
roypriyankar09@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyankar Roy |
| Designation |
Postgraduate Student |
| Affiliation |
KAHER KLE Vishwanath Katti Institute Of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC
Campus,Nehru Nagar,Belgaum
CAMPUS,NEHRU NAGAR,BELGAUM Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC
Campus,Nehru Nagar,Belgaum Belgaum KARNATAKA 590010 India |
| Phone |
9535428250 |
| Fax |
|
| Email |
roypriyankar09@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonal B Joshi |
| Designation |
Proffesor and Dean |
| Affiliation |
KAHER KLE Vishwanath Katti Institute Of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC
Campus,Nehru Nagar,Belgaum
CAMPUS,NEHRU NAGAR,BELGAUM Department of Conservative Dentistry and Endodontics, KAHER KLE Vishwanath Katti Institute Of Dental Sciences, JNMC
Campus,Nehru Nagar,Belgaum
CAMPUS,NEHRU NAGAR,BELGAUM Belgaum KARNATAKA 590010 India |
| Phone |
9535428250 |
| Fax |
|
| Email |
jsonal70@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and
Endodontics, KAHER KLE Vishwanath Katti Institute of
Dental Sciences, JNMC Campus,Nehru Nagar Belgaum
KARNATAKA 590010 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| 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 |
| Dr Priyankar Roy |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
DEPARTMENT OF
CONSERVATIVE DENTISTRY AND ENDODONTICS, KAHER KLE
VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES,JNMC
CAMPUS,NEHRU NAGAR,BELGAUM Belgaum KARNATAKA |
9535428250
roypriyankar09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K036||Deposits [accretions] on teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
445nm Diode Laser |
Activation of Whitness HP Maxx with 445nm for 40 secs. |
| Comparator Agent |
Non Activated |
No Activation of Whitness HP Maxx with 445nm for 40 secs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy maxillary left and right Central, lateral, and canine
2. Absence of caries, cervical lesions, and dental fillings.
3. Absence of dentin hypersensitivity.
4. Absence of clinically visible periodontal disease and periradicular lesions.
5.Absence of heavy discoloration on the studied teeth
|
|
| ExclusionCriteria |
| Details |
1.Patients who refuse to consent to the procedure.
2.Patients with any systemic diseases, pregnancy, or immunocompromised conditions.
3.Patients on medications, fluorosis, and endodontic treatment
4.Smokers and former smokers
5.Teeth having internal discoloration
6.Teeth with gingival recession and dentin exposure
7.Missing maxillary Central incisors/Lateral incisors/canine
8.Patient’s without submission to any other dental bleaching protocol in the previous 2 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and conduct an intragroup and intergroup comparison of the drop and relapse of shade after immediate post-bleaching, 7 days and 14 days, and post-operative sensitivity at 24 hours,72 hours |
For Shade drop- immediate post-bleaching, 7 days and 14 days.
sensitivity- immediate postoperative,24 hours,72 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and conduct an intragroup and intergroup comparison of the drop and relapse of shade after immediate post-bleaching, 7 days and 14 days, and post-operative sensitivity at 24 hours,72 hours |
For Shade drop- immediate post-bleaching, 7 days and 14 days.
sensitivity- immediate postoperative,24 hours,72 hours.
|
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2024 |
| Date of Study Completion (India) |
01/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A
bright smile always has a powerful impact on self-esteem and gives one an
overall feeling of well-being. In this era of online networking, where images
are widely shared, there’s an increased consciousness about personal
appearance, especially dental esthetics, and a desire to own a brighter smile. The pursuit of achieving whiter teeth has been a longstanding desire for many
people across different cultures and periods. Current bleaching agents intended for
in-office bleaching are based on higher concentrations of peroxides to achieve
more intense color changes. However, studies highlighted that,
though it is a preferable technique, a single application will not be
sufficient to achieve the desired effect rather it requires several treatment
sessions for a longer time.In
addition to stimulating the bleaching gel, lasers offer analgesic,
anti-inflammatory, and biomodulatory effects via low-intensity laser therapy
(LLLT) to counteract the negative consequences of this procedure. Previous studies on the effectiveness of
Whiteness HP Maxx (FMG, Brazil) have examined its impact both with and without
light activation, particularly regarding the reduction in shade intensity with
LED and Hybrid Lasers. However, there’s a gap in the literature concerning the
comparative efficacy of Whiteness HP Maxx with and without diode laser
activation in terms of shade reduction and post-bleaching sensitivity. Thus,
aim of our split-mouth study was to evaluate and compare the effectiveness of Whiteness
HP Maxx with and without 445nm Diode laser activation to check the
post-bleaching effective shade change and sensitivity of the tooth. |