Health Condition 1: K051- Chronic gingivitis
Conditions
Interventions
Intervention1: mouthwash containing Chlorhexidine, Zinc Chloride and Sodium Fluoride: Mouthwash for chronic gingivitis. Dosage is 10-15 ml twice daily. Route of administration is oral. Duration of the
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion 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
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 11)Any condition or device that could act as plaque retentive factor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Reduction in plaque from baseline as measured using Silness-Löe Plaque index at week 2 and week 4. â?¢ Reduction in gingival inflammation from baseline as measured using Gingival Index of Löe and Silness at week 2 and week 4. Timepoint: week 2 and week4 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Assessment of staining as measured by using Modified Lobene staining index at baseline, week 2 and week 4. â?¢ Tolerability will be assessed based on the spontaneous reports generated by the clinician and reported as per local regulatory guidelinesTimepoint: week 2 and week 4 | — |
Countries
India
Contacts
Public ContactShashi Kanth Muni
Dr Reddys Laboratories Ltd.
Outcome results
None listed