An human clinical study to check the efficacy of an herbal toothpaste in reducing Gingivitis (atooth-related condition) in Diabetic population.

Not yet recruiting

Conditions: Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2023/05/052497

Lead Sponsor: Amway Global Services India Pvt. Ltd.

Brief Summary: This is an open-label single arm human clinical study to investigate the efficacy of an herbal toothpaste (GHT - 12) in reducing Gingivitis (early stage of Periodontal disease) in Diabetic population. A total of **72** volunteers with known history of Diabetes Mellitus will be selected. All subjects will receive the intervention for 30 days. Dose and Regimen: Unsupervised, twice-daily brushing (2 minutes per brushing) for four weeks at home; and Supervised single brushing (2 minutes) at the study site during baseline and week-four visits. The Primary Efficacy: To assess change from baseline for Modified Gingival Index. Secondary Safety and efficacy Variables and Tools are as follows:

1.      To assess change from baseline for Plaque Index2.      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 Questionnaire

Subjects will be recruited as per Inclusion / Exclusion Criteria and assessed on Day 1, Day 10, Day 20 and Day 30.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 72

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess change from baseline for Modified Gingival Index.	Day 1, Day 10, Day 20, Day 30.

Secondary Outcome Measures

Name	Time	Method
1. To assess change from baseline for Plaque	Index

Trial Locations

Locations (1): KLE Societys Institute of Dental Sciences
🇮🇳
Bangalore, KARNATAKA, India
KLE Societys Institute of Dental Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Ashwin Prabhu
Principal investigator
9845011615
prabhu.ash@gmail.com