| CTRI Number |
CTRI/2024/10/075282 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy study of GuruNandas Signature Whitening Strips in Teeth Whitening |
|
Scientific Title of Study
|
Assessing the efficacy & safety of GuruNanda Signature Whitening Strips versus Lumineux Whitening Strips in teeth whitening: A double blind, randomized, comparative clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GNWHITESTRIP/19/24 Ver 1.0 Dated 23.09.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indumathi BDS MDS PhD |
| Designation |
Public Health Dentistry, Implantologist |
| Affiliation |
Deepam Hospitals |
| Address |
33,Station Rd, Selvaraj Nagar, Rohini Nagar, West,
Urapakkam, Chennai,
Tamil Nadu 603211
Chennai
TAMIL NADU
603211
India |
| Phone |
|
| Fax |
|
| Email |
drpradeeba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthi Balan MBBS MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room no.1, Ki3 office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 Private Limited |
| Address |
Room no.1, Ki3 office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Gurunanda LLC, 6645 Caballero Blvd.Buena Park, CA 90620 |
|
|
Primary Sponsor
|
| Name |
Gurunanda LLC |
| Address |
6645 Caballero Blvd.Buena Park, CA 90620 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Indumathi BDS MDS |
Deepam Hospitals |
Room No 1,Department of Dental First Floor, Deepam Hospital,
33,Station Rd, Selvaraj Nagar, Rohini Nagar,
West Urapakkam,
Chennai
Tamil Nadu 603211
Chennai
TAMIL NADU |
8754493511
drpradeeba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oxymed Ethics Committee |
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 |
| Intervention |
GuruNanda’s Signature Whitening Strips Professional |
PVP K30, Glycerin, Hydroxypropyl cellulose, PVP K90, Water, Coconut oil, Hydrogen peroxide, Menthol, Alcohol. |
| Comparator Agent |
Lumineux Whitening Strips |
Glycerin, Water, Carbomer, Carboxymethyl cellulose, Cocos nucifera (coconut) oil, Dead sea salt, Salvia officinalis (sage) Oil, Citrus limon (lemon) peel oil. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving teeth shade cosmetically and who agreed to comply with the study procedures |
|
| ExclusionCriteria |
| Details |
Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures;
Subjects with chronic or aggressive periodontitis; who underwent recent whitening intervention
Tobacco consumers and smokers, betel chewers
Subjects who are pregnant or lactating.
Subjects with hypersensitivity to any of the test products.
Subjects 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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess improvement in VITA Shade Scale over physical visits
2)Air Blast Hypersensitivity using dental air syringe-Examiner rates the response to stimulation of hypersensitive teeth using a jet of air (constant stimulus on the basis of duration, pressure, temperature, and distance from target). Response is rated based on the Schiff Cold Air Sensitivity Scale. This analog scale scores for the tooth are 0, 1, 2 or 3:
3) To assess the Enamel by Visual Inspection: Dentists visually inspect teeth for signs of enamel erosion, discoloration, and surface roughness. Healthy enamel should appear smooth, translucent, and glossy
4) To assess the Enamel by Tactile Examination: Using dental probes, the dentist can feel the texture of the enamel Mohs Hardness Scale for Enamel. Rough or pitted surfaces may indicate enamel wear or demineralization
5) Pictures of Oral Cavities |
Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To observe the safety of the Investigational Product throughout the study period for any abnormal findings on gingival and mucosal tissues, dental hard tissues, including but not limited to the gingiva (free and attached), hard and soft palate, oropharynx/uvula, buccal mucosa, tongue, floor of the mouth, labial mucosa, mucobuccal / mucolabial folds, lips, and perioral area.
2) Additionally, the oral hard tissues will be observe and abnormal finding questionnaire: burning mouth, altered taste, sore mouth, ulcers, change in gum colors, sensitivity etc. |
Baseline and Post Study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
04/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
60 adults requiring whitening intervention to improve teeth shade cosmetically, divided into 2 arms of 30 in each arm.
Group 1 ( n=30) - Subjects will use - GuruNanda’s Signature Whitening Strips once daily for 7 days.
Group 2 (n=30) - Subjects will use- Lumineux Whitening Strips, once daily for 7 days.
Primary Outcome :
1) To assess improvement in VITA shade scale over Physical visits 2) Air Blast Hypersensitivity using dental air syringe 3) To assess the Enamel by Visual Inspection 4) To assess the Enamel by Tactile Examination 5) Pictures of Oral Cavities
Timepoints : Baseline,Day 1, Day 3, Day 5 and Day 7
Secondary Outcome
1) To observe the safety of Investigational Product throughout the study Period 2) Additionally, the oral hard tissues will be observe and abnormal finding questionnaire: burning mouth, altered taste, sore mouth, ulcers, change in gum colors, sensitivity etc |