None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy males and females aged 25 to 45 years (both included); 2.Individuals with generally healthy oral tissues, without inflammation, redness, or pain, as confirmed by a comprehensive dental examination. This includes no current or recent (within the last 6 months) periodontal treatment or significant oral diseases; 3.Participants with perceived teeth discoloration and need to improve teeth whiteness and overall oral hygiene; 4.Participants with mild and moderate plaque with plaque index 2-4; 5.Participants who have all incisors and canines in the upper and lower jaw; 6.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments; Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1.Participants with A1, B1 and C1 shade on Vita Shade scale 2.Individuals with current alcohol or tobacco use 3.Known sensitivity or history of significant adverse effects to any of the investigational products 4.Significant unstable or uncontrolled medical condition which may interfere with a participant participation in the study 5.Participated in tooth stain removal trials in the least 3 months; 6.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers; 7.Participants using antibiotics or other medications that could affect oral health or interfere with the study results; 8.Participants involved in concurrent studies with similar assessments or interventions; 9.Participants experiencing severe dry mouth (xerostomia); 10.Participants with chronic bad breath (halitosis) due to treatment or any medical condition; 11.Participants with any known hypersensitivity of charcoal containing oral care products.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Macpherson s Modified Stain Index at baseline, week 4 and week 8. 2.Changes in Organoleptic Scoring Scale (OSS) at baseline, week 4, and week 8. 3.Compliance and tolerability will be assessed at week 4 and week 8.Timepoint: Screening, week 4, and week 8. | — |
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in teeth whitening assessed by VITA Shade Scale at screening, week 4, and week 8. 2.Changes in Investigational Product on Plaque Index (PI) at screening, week 4, and week 8.Timepoint: Screening, week 4, and week 8. | — |
Countries
India
Contacts
Chipper Consumer Pvt. Ltd