MedPath

Patient acceptance of a green tea-based mouth rinse

Phase 4
Completed
Conditions
Gingival disease
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Registration Number
ACTRN12619000359134
Lead Sponsor
Hani Mawardi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
40
Inclusion Criteria

healthy subjects who are 18 years or older and had not been using any oral rinses (including fluoride or bleaching rinse) for the past 2 weeks. In addition, study subjects should have stable oral condition with no pain at baseline.

Exclusion Criteria

Subjects with allergy to any component of the study mouth rinses, pregnant or lactating women, subjects with current alcohol consumption, recent periodontal surgery or extraction (at least for the past 3 months), taking any analgesics, participating in any other clinical trial (at least for the past 30 days), and regularly using any other mouth rinse.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
This will be a composite outcome assessment. Subjective tolerability measured through mouth burning sensation, mouth dryness, mouth pain, and dental sensitivity using a scale of 1 – 10 (1 indicates the lowest level and 10 indicates the highest level), malodor using yes/no question. In addition to taste sensation (1 – 10 scale) and texture of the mouth wash[14 days after initiation of treatment ]
Secondary Outcome Measures
NameTimeMethod
This will be a composite outcome assessment. Objective tolerability though assessment of the oral tissues for erythema, ulceration, desquamation and chronic bite injury.<br>Study PI will be assessing the oral tissues using a mirror, light and clinical features.[14 days after initiation of treatment ]
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