CTRI/2019/04/018353
Not yet recruiting
未知
Real World, Non-Interventional, Observational study to evaluate the Effectiveness and Tolerability of a mouthwash containing Chlorhexidine, Zinc Chloride and Sodium Fluoride with Anti-discoloration system in patients with Chronic Gingivitis.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: K051- Chronic gingivitis
- Sponsor
- Dr Reddys Laboratories Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Both genders with age between 18\-50 years, inclusive
- •2\)No relevant medical conditions that could interfere with periodontal health
- •3\)Willingness to provide written, informed consent and comply with study procedures
- •4\)Subjects diagnosed with chronic gingivitis in whom Principal Investigator has advised treatment with mouthwash containing Chlorhexidine, Zinc Chloride and Sodium Fluoride with Anti\-discoloration system. Diagnostic criteria must include one or more of the following:
- •a)Inflammation of gingiva (marginal, papillary or diffused)
- •b)Bleeding gums, localized or generalized
- •c)Colour changes from coral pink to red or bluish red of gingiva
- •d)No evidence of periodontitis
Exclusion Criteria
- •1\)Patients with a known or suspected hypersensitivity to Chlorhexidine or to any ingredients of the formulation
- •2\)Pregnant and lactating women
- •3\)Intrinsic or extrinsic stains on teeth
- •4\)Probing pocket depth \>3 mm and/or No clinical attachment loss at any site
- •5\)Antibiotic and/or anti\-inflammatory therapy within 3 months prior to baseline examination
- •6\)Oral mucosal lesions
- •7\)Current smokers
- •8\)Need for antibiotic premedication
- •9\)Patients on any oral medications known to cause staining of teeth
- •10\)Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers or anti\-inflammatory drugs/analgesics
Outcomes
Primary Outcomes
Not specified
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