Study to analyse usefulness of antibacterial (Chlorhexidine) containing mouthwash for the treatment of swollen and bleeding gums.

Not Applicable

Conditions: Health Condition 1: K051- Chronic gingivitis

Registration Number: CTRI/2019/04/018353

Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

11)Any condition or device that could act as plaque retentive factor

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Reduction in plaque from baseline as measured using Silness-LÃ¶e Plaque index at week 2 and week 4. <br/ ><br>â?¢Reduction in gingival inflammation from baseline as measured using Gingival Index of LÃ¶e and Silness at week 2 and week 4. <br/ ><br>Timepoint: week 2 and week4

Secondary Outcome Measures

Name	Time	Method
â?¢Assessment of staining as measured by using Modified Lobene staining index at baseline, week 2 and week 4. <br/ ><br>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