Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Mouth Rinse containing Chlorhexidine & Hyaluronic Acid: 10 ml of product twice daily (morning & evening) for the duration of 15 days
Control Intervention1: Placebo (i.e., Saline): 10 ml
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Males and Non-pregnant (self-declared)/Non-Lactating female subjects of age 18 to 50 years (both inclusive) at the time of consent. 2) Subjects who have undergone oral surgical procedure like tooth extraction, implant surgeries and periodontal surgeries. 3) Subjects willing to provide written informed consent for participating in the study. 4) Subject willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding or planning pregnancy during the study period. 2) Subjects receiving steroid medications, which would compromise the study. 3) Subjects having history of diabetes mellitus, acute cardiac and circulatory diseases, HIV, hepatitis. 4) Subjects with known allergy or sensitivity to Chlorhexidine and Hyaluronic Acid. 5) Subjects having problems of hemostasis and coagulation. 6) Subjects who consume alcohol. 7) Subjects smoking cigarette or consume any other form of tobacco. 8) Participation in a similar clinical study within the previous 30 Days. 9) 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 wound healing using Healing index scale (versus baseline & placebo). 2) Assessment of wound healing using Percentage healing index (PHI) (only for subjects who have undergone tooth extraction) (versus baseline & placebo).Timepoint: Day 01 (before product administration), Day 03, Day 07, Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Assessment of overall gum health by dental examination (versus baseline & placebo)Timepoint: Day 01 (before product administration), Day 03, Day 07, Day 15;2) Assessment of Subject Satisfaction Questionnaire after product administration.Timepoint: Day 03, Day 07, Day 15;3) Assessment of Product Response Index (Perception about Product) after product administration.Timepoint: Day 15 | — |
Countries
India
Contacts
Public ContactDr Rahul Rathod
Dr. Reddy’s Laboratories Ltd.
Outcome results
None listed