| CTRI Number |
CTRI/2025/07/090959 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Superfresh Whitening Toothpaste for Breath Freshness and Whitening Effect in Healthy adults |
|
Scientific Title of Study
|
Evaluation of SuperFresh Whitening Toothpaste for Breath Freshness
Efficacy and Whitening Effect in a Single-Arm Clinical 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 Anitha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Sankarachariyar Dental college |
| Address |
Room No 1, Dept. of Periodontology
Vinayaka Missions Sankarachariyar Dental
college Sankari Main Road (NH-47) Ariyanoor,
Salem - 636308 Tamil Nadu, India
Salem
TAMIL NADU
636308
India |
| Phone |
6379448862 |
| Fax |
|
| Email |
anu.jay210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Ki3 Private Limited |
| Address |
No. 5/3,Jayalakshmi Street, Radha Nagar, Chromepet, Chennai- 600 044 Tamil Nadu, India.
Chennai
TAMIL NADU
600044
India
Chennai
TAMIL NADU
600044
India |
| Phone |
09443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
No. 5/3,Jayalakshmi Street, Radha Nagar, Chromepet, Chennai- 600 044 Tamil Nadu, India.
Chennai
TAMIL NADU
600044
India
Chennai
TAMIL NADU
600044
India |
| Phone |
09003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Chipper Consumer Pvt. Ltd. (Perfora) Plot No. 250, 3rd Floor, Lynx House,
Udyog Vihar, IV, Sector 18, Gurugram, Haryana - 122015 |
|
Primary Sponsor
Modification(s)
|
| Name |
Chipper Consumer Pvt Ltd Perfora |
| Address |
Plot No. 250, 3rd Floor, Lynx House, Udyog Vihar, IV, Sector 18, Gurugram, Haryana - 122015 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Anitha BDS MDS |
Vinayaka Missions Sankarachariyar Dental College |
Room No 1, Periodontics Division,Department of Periodontology, Sankari Main Road (NH-47) Ariyanoor,
Salem - 636308 Tamil Nadu, India
Salem
TAMIL NADU |
06379448862
anu.jay210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Mission Sankarachariyar Dental COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
SuperFresh Whitening Toothpaste |
Sorbitol, Hydrated Silica, Aqua, Glycerine, Probiotics, Xylitol, Erythritol, Xanthan
Gum, Nano-Hydroxyapatite, Vitamin E, ImerCare® PerlWhite 19, Sodium Methyl Cocyl Taurate,
Cocamido Propyl Betain, Stevia, Potassium Sorbate, Menthol (Crystals), Peppermint (Essential
Oil), Spearmint (Essential Oil), Cellulose Microspheres.
All the study participants will receive Perfora Electric Tooth Brush .Take a pea sized Toothpaste
on a wet Perfora Electric Toothbrush and brush twice every day by modified bass technique for 2
minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult Participants in the age group of 18-60 years who prefer to improve teeth
shade cosmetically and who would want to maintain oral hygiene and to comply with the
study procedures.
study procedures.
Tooth shades: B2, D2, A2, C2, D3, A3, D4, B3, A3.5, B4, C3, A4, and C4.
Gingivitis Severity: Participants must have a Löe and Silness Gingival Index score greater than 1,
indicating moderate to severe gingival inflammation.
Dental Plaque Level: Participants must have a Turesky modification of the Quigley-Hein
Plaque Index score greater than 1.
Good general health with no systemic conditions affecting oral health.
Presence of natural teeth with visible extrinsic stains or discoloration.
Willingness to avoid other whitening treatments during the study period.
Ability to provide informed consent.
Compliance with study protocols, including scheduled visits and post-treatment care.
|
|
| ExclusionCriteria |
| Details |
Tooth shades: A1, B1 and C1
Wearing orthodontic appliances like a clear aligner, retainer, and night guard/ braces.
Participants with mal-aligned teeth and removable partial dentures
Participants with chronic or aggressive periodontitis; who underwent recent whitening
intervention
Tobacco consumers, smokers and betel chewers.
Participants who are pregnant or lactating.
Participants with hypersensitivity to any of the test products.
Participants with pre-existing tooth sensitivity
Concurrent use of any other treatment for teeth whitening or sensitivity
Concurrent participation in any other clinical trial or study involving teeth whitening or
sensitivity assessment.
Severe enamel defects or intrinsic discoloration unrelated to staining.
Prior participation in a similar study within the past six months.
Current use of medications causing tooth discoloration, such as tetracycline
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess improvement in VITA shade (by using VITA Easy Shade
Evaluate the efficacy of the product in preventing mouth odour,
providing a sustained sensation of oral freshness for up to 12
hours, and maintaining fresh breath throughout the day, as well as
promoting a clean and healthy oral environment . The assessment
will be conducted by using Organoleptic Scoring Scale (OSS) and
Assessment by Halimeter.
5- 3D master) scale over various time points. [Time Frame: Baseline,
Day 30 and Day 60]
Macpherson Stain Index
Oral Hygiene Index Simplified (OHI-S)
Dental Plaque will be assessed using Turesky modification of the
Quigley Hein Plaque Index. Baseline, Day 30 and Day 60]
Gingivitis scale using Loe and Silness Gingival Index. [Time Frame:
Baseline, Day 30 and Day 60]
Photographic assessment of oral cavity [Baseline & Day 60] |
Baseline, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Participants will be provided with a diary to monitor usage
Page 9 of 45
Protocol No: SFW/07/25
Version: 1.1
OUTCOME
Participant and Investigator feedback will be obtained using 5-point
likert scale questionnaire
Adverse event monitoring |
Baseline, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
21/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/11/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This Phase 3, single-arm clinical study demonstrated that Superfresh Whitening Toothpaste formulated with nano-hydroxyapatite, probiotics, polyols, controlled abrasives, and essential oils, significantly improved dental aesthetics, breath freshness, and oral hygiene over a 60-day period in 30 healthy adults. Teeth-whitening efficacy was confirmed through VITA shade, delta E, and CIELAB values. The toothpaste produced an immediate and reproducible reduction in volatile sulfur compounds and organoleptic scores at all visits, with sustained effects up to 12 hours and cumulative improvement by Days 30 and 60. Oral hygiene markers including OHI-S, QHPI, and Gingival Index showed rapid and progressive improvement throughout the study duration. The product was well tolerated, with only mild, transient adverse events and no discontinuations. Participant feedback reflected high acceptability, with strong ratings for freshness, whitening, comfort, sensory attributes, and overall satisfaction. Overall, the findings confirm that Superfresh Whitening Toothpaste offers effective, safe, and well-tolerated whitening and oral-care benefits.
|