To Evaluate the efficacy and safety of Himalaya Organique Toothpaste for its antiplaque activity on subjects with skin type I and II having plaque.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/08/001952

Enrollment

Registered

2011-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Himalaya Herbal Tooth Paste. (Neem and Pomegranate Tooth Paste): Each enrolled volunteer will be brushing twice a day with IP (paste) for 28 days. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: ? Must give written informed consent and abide by the protocol sincerely and regularly visit the site for follow up ? Subjects aged between 20-50 years, and of skin type I and II ? Male and Female subjects with dental plaque. ? Wash out period: No other medicated toothpaste/mouthwash for 1 week. ? Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present ? Be in good general health. ? Subjects who have not participated in similar clinical study in the past four week before enrolling into the study.

Exclusion criteria

Exclusion criteria: ? Subjects with preexisting systemic diseases necessitating long term medications ? Subjects having advanced Dentist disease ? Subjects having diseases of soft /hard tissues ? Subjects having Orthodontic appliances ? Subjects with Abnormal salivary function ? Use of oral antibiotics one (1) month prior to or during this study ? Pregnant or breastfeeding ? Participation in another clinical study in the past one month preceding this study ? Allergic to common dentifrice ingredients ? Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) ? Subjects who have the habit of consuming alcohol, smoking, chewing gums, pan or gutka. ? Subjects having orthodontic problems but not under any kind of orthodontic treatment . ? Subjects should not allow to use any other dental aid. ? Subjects not adhering to the oral hygene instructions given and not maintaining oral health. ? Subjects suffering halitosis due to systemic causes. ? Subjects having deficiency disorders like scurvy. ? Subjects having abnormal frenum attachment. ? Subjects who are mouth breathers, tongue thrusters and bruxers. ? Subjects having masochistic habits like tooth pick injury. ? Subjects using other dental aids or using hard bristle brushes.

Design outcomes

Primary

Measure	Time frame
Control plaque formation, fight against germs, Prevent bad breath, improve gum tightening, prevent gum bleeding and to provide complete protection to gums and teeth by visual assessment of dentist, digital photography and dental swab for plating and count of bacteria.Timepoint: Subject will be visiting the site day 1, day 7, day 14, day 21, day 28. The outcome will be assessed after 28 days for each subject.	—

Measure

Time frame

Control plaque formation, fight against germs, Prevent bad breath, improve gum tightening, prevent gum bleeding and to provide complete protection to gums and teeth by visual assessment of dentist, digital photography and dental swab for plating and count of bacteria.Timepoint: Subject will be visiting the site day 1, day 7, day 14, day 21, day 28. The outcome will be assessed after 28 days for each subject.

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Mridu Ashok Kaushal

Dr. Mukta Sachdev Clinic

mrids09@gmail.com919886125442

Outcome results