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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 periodsCurrent 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.

 
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