Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: GHT-12: Herbal toothpaste with herbal actives (Xylitol and combination of essential oils and extracts) for brushing twice daily.
Control Intervention1: Not Applicable.: Not Applicable.
Sponsors
Amway Global Services India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of gingivitis 2. All subjects fulfilled at least one or more of the clinical criteria 3. Controlled diabetes mellitus 4. Having at least 20 teeth 5. Agreement to participate in the study 6. Able and willing to follow all study related instructions. 7. Must be willing to give written informed consent and comply with the study procedures. 8. Subjectâ??s complete blood count parameters to be within clinically acceptable range by Investigator. 9. No history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 1 month
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity reaction 2. Smoking/ consuming Betel nut/Pan/ Beeda 3. Systemic diseases (Kidney, liver or rheumatologic diseases) 4. To have a pocket depth of more than 5mm 5. Consumption of antibiotics, corticosteroids or nonsteroidal anti-inflammatory drugs in the past 1month and during the study period 6. Subjects with known allergies to the constituents of the formulation 7. Subjects with uncontrolled Hypertension, endocrinal, metabolic disorders excluding diabetes mellitus, underlying heart conditions and other uncontrolled systemic disorders 8. Pregnant and lactating females 9. Subjects undergoing orthodontic treatment 10. Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change from baseline for Modified Gingival Index.Timepoint: Day 1, Day 10, Day 20, Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess change from baseline for Plaque Index 2. To assess change from baseline for Bleeding Index 3. To assess change from baseline for Pocket depth 4. To assess change from baseline for S. mutans count 5. To assess change from baseline in reduction of malodour 6. To assess change from baseline in hypersensitivity 7. To assess change from baseline in teeth whiteness 8. To assess change from baseline in extrinsic stains 9. Subjective perception or Subject satisfaction 10. Product Acceptability QuestionnaireTimepoint: Day 1, Day 10, Day 20, Day 30. | — |
Countries
India
Contacts
Public ContactMr Siddesh Shetty
KLE Societys Institute of Dental Sciences
Outcome results
None listed