None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female aged 25 to 55 years (Both include)2.Individuals with generally healthy oral tissues, 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 who have all incisors and canines in the upper and lower jaw.4.Individuals in good general health without any systemic conditions or medications that could affect oral health or interfere with the study treatments.5.Participants who provide written informed consent to participate in the study and comply with all study procedures and requirements.
Exclusion criteria
Exclusion criteria: 1.Suspected alcohol or substance abuse e.g. amphetamines, benzodiazepines, cocaine, and marijuana opiates. 2.Individuals with current alcohol or tobacco use. 3.Females who are pregnant or breastfeeding. 4.Known sensitivity or history of significant adverse effects to any of the investigational products. 5.Significant unstable or uncontrolled medical condition which may interfere with a subjects participation in the study. 6.Participated in tooth stain removal trials in the least 3 months. 7.Individuals who are unable to adhere to the study protocol or have conditions that may interfere with compliance, including cognitive impairments or language barriers. 8.Participants using antibiotics or other medications that could affect oral health or interfere with the study results. 9.Participants involved in concurrent studies with similar assessments or interventions. 10.Participants experiencing severe dry mouth like xerostomia. 11.Participants with chronic bad breath halitosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in VITA Shade Scale. 2. Changes in Macpherson’s Modified Stain Index. 3. Changes in tooth sensitivity and gum discomfort using Wong Bakers Face Scale.Timepoint: baseline, week 1 and week 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Investigational Product on Plaque Index (PI) and Modified Gingival Index (MGI). 2. Changes in % mean reduction CFUs in Gram-positive and negative bacteria. 3. Changes in improvement in Clinical Oral Dryness Score (CODS). 4. Changes in Organoleptic Scoring Scale (OSS). 5. Compliance and tolerability will be assessed. Timepoint: baseline, week 1, and week 2 | — |
Countries
India
Contacts
Mprex Healthcare Pvt. Ltd.