| CTRI Number |
CTRI/2023/05/052497 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Herbal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An human clinical study to check the efficacy of an herbal toothpaste in reducing Gingivitis (a
tooth-related condition) in Diabetic population. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMW/ CTP/GPD/06-2022, Version 1.0, 08/11/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Prabhu |
| Designation |
Principal Investigator |
| Affiliation |
KLE Societys Institute of Dental Sciences |
| Address |
KLE Societys Institute of Dental Sciences Room No. 12, First Floor,
No.20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bengaluru.
KLE Societys Institute of Dental Sciences Room No. 12, First Floor,
No.20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bengaluru.
Bangalore
KARNATAKA
560022
India |
| Phone |
9845011615 |
| Fax |
|
| Email |
prabhu.ash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Prabhu |
| Designation |
Principal Investigator |
| Affiliation |
KLE Societys Institute of Dental Sciences |
| Address |
KLE Societys Institute of Dental Sciences Room No. 12, First Floor,
No.20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bengaluru.
KLE Societys Institute of Dental Sciences Room No. 12, First Floor,
No.20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bengaluru.
KARNATAKA
560022
India |
| Phone |
9845011615 |
| Fax |
|
| Email |
prabhu.ash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Siddesh Shetty |
| Designation |
Project Manager |
| Affiliation |
Biosam CRO |
| Address |
No.21/1 Lakshmipura Main Road
Vidyaranyapura Post Bangalore.
No.21/1 Lakshmipura Main Road
Vidyaranyapura Post Bangalore.
Bangalore
KARNATAKA
560097
India |
| Phone |
9738877298 |
| Fax |
|
| Email |
siddu.shetty.jaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amway Global Services India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Amway Global Services India Pvt. Ltd. |
| Address |
Amway Global Services India Pvt Ltd Gurugram, Haryana India |
| Type of Sponsor |
Other [Private Limited Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwin Prabhu |
KLE Societys Institute of Dental Sciences |
KLE Societys Institute
of Dental Sciences,
No.20, Yeshwanthpur
Suburb, II Stage,
Tumkur Road,
Bengaluru, Karnataka
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9845011615
prabhu.ash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GHT-12 |
Herbal toothpaste with herbal actives (Xylitol and combination of essential oils and extracts) for brushing twice daily. |
| Comparator Agent |
Not Applicable. |
Not Applicable. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. Subject’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
|
|
| ExclusionCriteria |
| Details |
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 subject’s inclusion for the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess change from baseline for Modified Gingival Index. |
Day 1, Day 10, Day 20, Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 Questionnaire |
Day 1, Day 10, Day 20, Day 30. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |