None listed
Conditions
Interventions
Intervention1: Triple Combination Mouthwash containing Chlorhexidine gluconate 0.20 % w/v, Sodium fluoride 0.05 % w/v, Zinc chloride 0.09 % w/v: Rinse the mouth using 10 ml mouthwash twice daily for d
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants having good general health as determined by the Investigator on the basis of medical history and vital signs. 2) Participants with mild to severe gingivitis (Gingival index of 1 3). 3) Participants with Periodontal pocket depth less than or equal to 3 mm. 4) Participants with at least 20 permanent natural teeth with buccal & lingual scorable surfaces. 5) Participants having slight to strong oral malodor / bad breath (2 to 4) associated with periodontal disease as determined by Organoleptic Scoring Scale.
Exclusion criteria
Exclusion criteria: 1) Participants who are allergic to chlorhexidine or any of the components of study products. 2) Participant with severe periodontal disease (purulent exudate, tooth mobility with grade 3, and/or extensive loss of periodontal attachment or alveolar bone) requiring periodontal treatment during the study duration. 3) Participants with any fixed or removable prosthetic/orthodontic appliance. 4) Participants having tumor(s) of the soft or hard tissues of the oral cavity. 5) Participants who are at increased risk of bleeding complications from dental treatment, based on medical history. 6) Participants having a history of acute cardiac and circulatory diseases, HIV, hepatitis, uncontrolled hypertension and Hyperthyroidism. 7) Participant suffering from systemic diseases like diabetes mellitus, hypertension, Immunological disorders, etc. 8) Participants who were using chlorhexidine or antibiotics or any other topical medication within the previous 3 months. 9) Participants who are receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs. 10) Participants who are currently receiving dialysis. 11) Participants who require Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections, extractions, impactions, implant placement, irreversible pulpitis, surgical removal of cysts and tumors, mucositis due to radiotherapy/chemotherapy). 12) Pregnant or breastfeeding or planning pregnancy during the study period. 13) Heavy alcohol consumption (on average more than 2 drinks/day for women and more than 3 drinks/day for men). 14) Participants smoking cigarette or consume any other form of tobacco. 15) Any other condition which could warrant exclusion from the study, as per the investigator s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of gingivitis using gingival index 2. Proportion of participants achieving gingival index score of 0 3. Proportion of participants with treatment-emergent adverse events (TEAEs)Timepoint: 1. Day 01, Day 07, Day 15 and Day 28 2. Day 07, Day 15 and Day 28 3. Throughout the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of plaque formation using plaque indexTimepoint: Day 01, Day 07, Day 15 and Day 28;Proportion of participants achieving plaque index score of 0Timepoint: Day 07, Day 15 and Day 28;Assessment of bleeding using Sulcus Bleeding IndexTimepoint: Day 01, Day 07, Day 15 and Day 28;Proportion of participants achieving bleeding index score of 0Timepoint: Day 07, Day 15 and Day 28;Assessment of halitosis using Organoleptic Scoring ScaleTimepoint: Day 01, Day 07, Day 15 and Day 28;Proportion of participants achieving organoleptic score of 0Timepoint: Day 07, Day 15 and Day 28;Assessment of pocket depth using periodontal probe and grading scaleTimepoint: Day 01 and Day 28;Assessment of Oral Hygiene using Simplified Oral Hygiene Index (OHI-S)Timepoint: Day 01, Day 07, Day 15 and Day 28;Subjective Evaluation QuestionnaireTimepoint: Day 01, Day 07, Day 15 and Day 28;Participants PerceptionTimepoint: Day 28 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Cliantha Research
Outcome results
None listed