| CTRI Number |
CTRI/2023/09/057700 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the safety and effectiveness of toothpaste in human subjects with diabetes |
|
Scientific Title of Study
|
An open label, single arm, multicentric clinical study to evaluate the efficacy and safety of HHTD-092201 (toothpaste) for Comprehensive Oral Care in Individuals with Diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/027/2023 Version - Final 1.0 Dated 21 Aug 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pusthi Purohit |
| Designation |
Principal Investigator |
| Affiliation |
Vraj Dental Clinic |
| Address |
Vraj Dental Clinic, FF 5, Shukan Platinum, Vandematram Cross Road, New S.G. Road, Gota, Ahmedabad, Gujarat
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
drpushtipurohit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNayan Patel |
| Designation |
Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex,
Near Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company, Makali, Bengaluru 562 162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Makali, Bengaluru 562 162, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jahanvi Chavda |
Dr.Yogesh Shahs Dental clinic |
Clinical Trial Department, 109, Vandemataram Fabula,
Malabar County Road,
Gota, Ahmedabad – 382481
Ahmadabad
GUJARAT |
07948983895
drjahanvichavda@gmail.com |
| Dr Pushti Purohit |
Vraj Dental Clinic |
Clinical Trial Department
FF 5, Shukan Platinum,
Vandematram Cross Road,
New S.G. Road, Gota,
Ahmedabad, Gujarat 382481
Ahmadabad
GUJARAT |
07948983895
drpushtipurohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E089||Diabetes mellitus due to underlying condition without complications, (2) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HHTD-092201 |
Subjects will be instructed to use one bristle length portion of test product and do brush everyday.
Frequency: 2 times daily (morning and evening)
Duration: 90 days |
| Comparator Agent |
None |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with history of diabetes with HbA1c 6.5 to 10% (as determined by HbA1c report not more than 1 month old)
2. Subjects currently under standard of care for diabetes control.
3. Subjects with age group 25 to 60 years
4. Subjects with mild to moderate periodontal complications as determined by Russell’s Periodontal Index
5. Subjects having at least 20 natural teeth
6. Willing to sign informed consent document and abide by the study procedures |
|
| ExclusionCriteria |
| Details |
1. Subject with history of Periodontal treatment performed within last 6 months of study onset
2. Subjects with intrinsic dental stains like smokers, tobacco chewers, etc
3. Subjects with known history of hypersensitivity to any test product
4. Pregnant and lactating subjects (female with child-bearing potential enrolled after Negative Urine Pregnancy test and advised suitable contraceptive method)
5. Subjects with active infectious diseases or poor immunity (like known case of hepatitis, human immunodeficiency virus, tuberculosis) as determined by the investigator
6. Subjects using any other technique to clean teeth (including tobacco, plant sticks etc) apart from toothpaste and brushing
7. Subjects with poor oral hygiene or poor oral condition which may interfere with the study results as determined by the investigator
8. Subjects with known bleeding disorders or vitamin C deficiency
9. Subjects with previous oral surgery or permanent dental malformations (like oral cyst, tumors, etc)
10. Subjects with orthodontic appliance (like braces, brackets, wires, etc)
11. Subjects with recent history (within 3 months) of dental prosthetic appliances (like partial dentures)
12. Subjects with congenital abnormalities such as cleft lip, cleft palate, tethered labial frenulum, etc)
13. Subject with clinically significant medical or oral conditions (like serious diabetic macrovascular diseases, severely deranged kidney or liver functions, vasculitis) that might interfere with the outcome of the study as determined by the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. In supporting periodontal health by using Russell’s periodontal index.
2. In improving hydration in oral cavity by using Schirmer test
3. In reducing plaque buildup as evaluated by Loe & Silness Plaque index.
4. In reducing gum inflammation using Loe & Silness Gingival index.
5. In reducing mouth odor, providing mouth freshness, giving clean & healthy mouth feel by using Organoleptic scale. |
Day 1, Day 30, Day 60 and Day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In suitability to provide comprehensive oral care in individuals with diabetes through Subjective self-assessment questionnaire |
Day 1, Day 30, Day 60 and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
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, multicentric clinical study to evaluate the efficacy of test
product in individuals with diabetes.
Enrollment: Following provision of informed consent and completion of all
screening assessments, eligible subjects will receive the test product. A
total of 50 subjects to be enrolled with a minimum of 40 subjects expected
to complete the study.
Test product usage: Before the start of the study all subjects will be given instructions
for oral hygiene, and usage of the products, brushing time and technique.
Subjects will be instructed to brush their teeth twice daily, in morning before
breakfast and at night just before sleeping. All subjects will be asked to
avoid eating/drinking food for 30 minutes before the clinical evaluations. All
subjects will be asked to clean the mouth thoroughly with fresh water before
clinical evaluation.
Duration: The study duration is 12 weeks, during which, the subjects will be
instructed to brush their teeth twice daily with the test product. The subjects
will undergo safety and efficacy assessments at Day 1, Day 30+2, Day 60+2
and Day 90+2.
Study endpoints:
Efficacy End points:
The efficacy of test
product assessed by the difference between mean scores of Investigator
assessment scales from baseline to EOS:
Russell’s Periodontal Index
Loe & Silness Gingival
index
Loe & Silness Plaque
index
Odor analysis by
Organoleptic scale
Oral hydration analysis by
Schimer’s test
Safety End Point:
The safety of test product
assessed by the following:
Non worsening of Buccal
Irritation Scoring from baseline to EOS
Adverse events(AE): AEs will be continuously
monitored. All AEs will be followed until resolution or deemed stable or until
the event is found to be due to another known cause (concurrent condition or medication)
and clinical judgment indicates that further evaluation is not warranted.
Should an Investigator be made aware of any serious AE (SAE) occurring any time
after the active reporting period, the SAE (in case of reasonable causality)
will be reported to Sponsor within 24 hours. |