Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Test Toothpaste: Pea sized product to be used twice a day as per modified Bass technique for brushing for duration of 1 month.
Control Intervention1: Marketed Toothpaste: Pea sized prod
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 60 years (both inclusive) at the time of consent. 2) Gender: Males and Non-pregnant /Non-Lactating females. 3) For Group 1: a. Healthy subjects as determined by the Investigator based on medical history and vital signs. AND For Group 2: a. Subjects with Type 2 Diabetes Mellitus, reported HbA1c level between 6.5 to 8 in past 3 months. b. Subjects with physician diagnosed type 2 diabetes of more than three months duration and who are currently under the care of a physician for diabetes management. 4) Subjects with moderate to severe (3 to 4) plaque as determined by Plaque Index System. 5) Subjects with mild to moderate (1 to 2) gingivitis/periodontitis. 6) Subjects having slight to strong oral malodor / bad breath (2 to 4) associated with periodontal disease as determined by Organoleptic Scoring Scale. 7) Subjects who are willing to come to the test site without brushing their teeth in the morning of visit 01 [Screening, Enrollment and Baseline Visit (Day 01)]. 8) Subjects who are willing to participate in the study and give a signed consent. 9) Subjects should be 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 not willing to follow all the acceptable forms of contraception as applicable. 3) Subjects with orthodontic bands and partial removable dentures. 4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity. 5) Subject with advanced periodontal disease (purulent exudate, tooth mobility with grade 3, and/or extensive loss of periodontal attachment or alveolar bone). 6) Subjects having history of acute cardiac and circulatory diseases, HIV, hepatitis, uncontrolled hypertension and Hyperthyroidism. 7) Subjects who are receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs. 8) Subjects who are undergoing chronic treatment with systemic antibiotics 9) Subjects who are currently receiving dialysis. 10) Subjects who are at increased risk of bleeding complications from dental treatment, based on medical history. 11) Subjects 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) Heavy alcohol consumption (on average more than 2 drinks/day for women and more than 3 drinks/day for men). 13) Subjects smoking cigarette or consume any other form of tobacco. 14) Participation in a similar clinical study within the previous 30 Days. 15) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of reduction in gingivitis assessed using gingival index between 2 products.Timepoint: Day 30 (+ 02 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of gingivitis assessed using gingival indexTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Assessment of plaque formation using plaque index and disclosing agentTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Assessment of pocket depth or clinical level attachment using a periodontal probeTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Assessment of bleeding gums using WHO probeTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Assessment of halitosis using Organoleptic Scoring Scale.Timepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Assessment of overall gum health by dental examinationTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60;Subjective questionnairesTimepoint: Day 01, Day 07, Day 15 and Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Sagar Katare
Dr Reddys Laboratories Limited
Outcome results
None listed