A clinical study to test the effect of 2 product formulations against a control, on gingival conditions and plaque levels, in an experimental gingivitis model after 3 weeks of home use.

A single centre, randomized, double blinded, controlled experimental gingivitis model to compare the efficacy of 2 product formulations against a regular toothpaste.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2009/091/000626

Enrollment

100

Registered

2009-08-28

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: Reduce gingivitis and plaque levels- acitve Zinc chloride with antioxidants: Topical application, Twice Daily for 3 weeks Control Intervention1: Zinc Chloride: Topical Application, Twic

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to understand and sign a consent form prior to the recruitment on the study. 2. Male and female subjects 18 -45 years 3. Patients with moderate gingivitis MGI average &#8805;2 but showing no signs of periodontitis (absence of periodontal pockets ) 4. Minimum 24 scorable, non restored natural teeth. 5. Good general and oral health 6. Ability and willingness of subjects to follow the study procedures(refraining from all oral hygiene method except study product use for 3 weeks,) attend all scheduled visits and successfully complete the study

Exclusion criteria

Exclusion criteria: 1. Periodontitis, active unfilled caries , heavy stains 2. Compulsive paan or tobacco consumers 3. Orthodontic bands, dentures 4. Allergy to any dental or oral hygiene products 5. Medical conditions that would affect oral health eg. Diabetes, 6. Females who are pregnant or nursing or use contraceptive pills. 7. Recent use of anti-inflammatory or antibiotic medicaments. 8. Participating in any other study.

Design outcomes

Primary

Measure	Time frame
Initial scores of Modified Gingival Index (Lobene), Bleeding index (Saxton and van der Ouderaa), Plaque Index (Modified Quigley Hein Plaque Index)compared to scores after 3 weeksTimepoint: 3 weeks	—

Secondary

Measure	Time frame
Modified Gingival Index (Lobene), Bleeding index (Saxton and van der Ouderaa), Plaque Index (Modified Quigley Hein Plaque Index)Scores after two and three weeksTimepoint: 2 weeks & 3 weeks	—

Countries

India

Contacts

Public ContactDr Vaishali Karad

drvaishali@smilecareindia.com02226431670

Outcome results