A study to evaluate and compare the efficacy of test mouthwash against non users on the gingival condition and plaque levels after 12 weeks of home use.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000035

Enrollment

Registered

2010-01-29

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: Mouthwash use in addition to Toothpaste- Toothbrush: 20 ml for 30 sec. twice daily post brushing Control Intervention1: Toothpaste -Toothbrush use only: Twice daily

Eligibility

Inclusion criteria

Inclusion criteria: 1. Able to understand and sign a consent form prior to the recruitment on the study. 2. Male and female subjects 18-50 years. 3. Subjects with mild to moderate gingivitis MGI score > 1.75 and PI score> 2. 4. Minimum 20 teeth 5. Generally good oral health (no sign of periodontitis, no active caries & no soft tissue lesions) 6. Ability and willingness of subjects to follow the study procedures and attent all scheduled visits and successfully complete the study.

Exclusion criteria

Exclusion criteria: 1. Periodontitis 2. Active caries 3. Smokers and compulsive tobacco chewers 4. Orthodontic appliances/ dentures 5. Compromised medical condition 6. Pregnant or nursing females 7. Mouthwash users 8. Allergy 9. Systemic ailments or on going medicaments 10. Participating in any other trials or less than 1 month gap from the previous trial participation

Design outcomes

Primary

Measure	Time frame
Initil Scores of Modified Gingival Index (Lobene) and plaque Index (Modified Quigley Hein Index)compared to Scores after 12 weeks (3 months)Timepoint: 12 weeks (3 months)	—

Secondary

Measure	Time frame
Modified Gingival Index (Lobene) and plaque Index (Modified Quigley Hein Index) Scores after 6 and 12 weeksTimepoint: 6 week & 12 week	—

Countries

India

Contacts

Public ContactRagi Menon

ragi@smilecareindia.com02226413670

Outcome results