Safety and Efficacy study of GuruNandas Signature Whitening Strips in Teeth Whitening

Assessing the efficacy & safety of GuruNanda Signature Whitening Strips versus Lumineux Whitening Strips in teeth whitening: A double blind, randomized, comparative clinical study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075282

Enrollment

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: GuruNanda’s Signature Whitening Strips Professional: PVP K30, Glycerin, Hydroxypropyl cellulose, PVP K90, Water, Coconut oil, Hydrogen peroxide, Menthol, Alcohol. Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 CavitiesTimepoint: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study	—

Measure

Time frame

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 CavitiesTimepoint: Baseline, 30 minutes, at the end of Day 1, Day 3, Day 5 and Post study

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Secondary

Measure	Time frame
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.Timepoint: Baseline and Post Study	—

Measure

Time frame

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.Timepoint: Baseline and Post Study

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Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

KI3 PRIVATE LIMITED

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026