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CTRI Number  CTRI/2022/08/044960 [Registered on: 26/08/2022] Trial Registered Prospectively
Last Modified On: 25/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to check the safety and effectiveness of toothpaste 
Scientific Title of Study   An Open Label Clinical Study to Evaluate The Oral Mucosal Safety and Efficacy of HBHT-102110 in Healthy Adult Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/CPD/022/2022 version 1.0 dated 04 Jul 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vamsi Kalyan Y 
Designation  Consultant dentist  
Affiliation  Dental Care Centre 
Address  Dental Care Centre 268 9th A Main Jayanagar 2nd Block Bangalore

Bangalore
KARNATAKA
560011
India 
Phone  9886300821  
Fax    
Email  yaragondavamsi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi B 
Designation  Clinical Team Lead 
Affiliation  Himalaya wellness company 
Address  Himalaya Wellness Company Makali Bangalore
RnD, 3rd floor, Medical Services and Clinical development department, Makali Bangalore
Bangalore
KARNATAKA
562162
India 
Phone  9538969888  
Fax    
Email  dr.swathi.b@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Clinical operations Manager 
Affiliation  Himalaya wellness company 
Address  Himalaya Wellness Company Makali Bangalore
RnD, 3rd floor, Medical Services and Clinical development department, Makali Bangalore
Bangalore
KARNATAKA
562162
India 
Phone  8105466999  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company 
 
Primary Sponsor  
Name  Himalaya wellness company 
Address  Makali Bangalore 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vamsi Kalyan Y  Dental Care Centre  268, ground floor, 9th A Main Jayanagar, 2nd Block, Bangalore
Bangalore
KARNATAKA 		 9886300821

yaragondavamsi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Hydroxyapatite toothpaste, Reference: NA, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects with age group 18 years to 60 years in general good health and oral health and are willing to provide consent to the study
2. Subjects with moderate oral hygiene and adhering to basic habits like using standard brush paste
3. No history of any clinically significant medical condition
4. No history of any medical problems requiring hospital care
5. Willing to abide by and comply with the study protocol
6. Available to comply the study procedure for the entire duration of the study.
7. Should not have participated in a similar investigation in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study
 
 
ExclusionCriteria 
Details  1.A known history or present condition of hypersensitivity to any test product
2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette
3.Pregnant and lactating subjects
4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month
5. Any history of periodontal therapy by surgical interventions
6.Any history of dentine hypersensitivity treatment
7. Any removable appliances such as a removable partial denture or orthodontic retainer
8.Having intrinsic dental stains
9.Having Chronic Generalized Periodontitis
10. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index
2. To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index
3. To determine the teeth whitening effect of test product as evaluated by VITA shade card.
4. To determine efficacy in Preventing mouth odour, providing of Mouth freshness upto X hours, maintain clean and healthy mouth and providing fresh breath through subjective self-administered questionnaire 		 Baseline/ day 1
Day 15
Day 30
Day 45 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the safety of test product by buccal irritation score and subject reported adverse events.  Baseline/ day 1
Day 15
Day 30
Day 45 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   31/08/2022 
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="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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 a prospective, open label, clinical study to evaluate the oral mucosal safety and efficacy of test product in healthy adult subjects.

A total of 40 subjects are expected to complete the study.

Following provision of informed consent and completion of all screening assessments, eligible subjects will receive the test product.

Before the start of the study all subjects will be given instructions for oral hygiene, and usage of the test product, brushing time and technique.

Subjects are instructed to use pea size amount of toothpaste, brush thoroughly and do not swallow. Toothpaste was used for brushing the teeth for 2 mins, twice a day (In the morning and before bedtime) for 45days. First use will be done at site, pre and post use of test product assessment will be done on day 1.

   All subjects will be asked to avoid eating/drinking food for 30 minutes before the clinical evaluations.

Clinical assessment:

Each participating volunteer will complete a baseline dental examination on day 1 before use of test product and subjects will be asked to brush the teeth at site and assessment will be performed post use of test product.

The following clinical assessments will be carried out by the Investigator

The clinical efficacy assessment will be carried out through:

1.       Silness and Loe plaque index

2.       Loe and Silness Gingival Index

3.       VITA Shade

4.       Subjective self-administered questionnaire

Safety assessment:

1.       Buccal irritation scoring as safety parameter

2.       Adverse event reporting

Plaque index: The efficacy of test product in fighting plaque will be assessed by evaluating Silness and Loe plaque index (1965).

The plaque scores will be based on recording both soft debris and mineralized deposits on the teeth. Each of the four surfaces of the teeth (buccal, lingual, mesial and distal) will be given a score from 0-3. The scores from the four areas of the tooth are added and divided by four in order to give the plaque index for the tooth with the following scores and criteria:

Scores

Criteria

0

No plaque

1

A film of plaque adhering to the free gingival margin and

Adjacent area of the tooth. The plaque may be seen in situ only after

application of disclosing solution or by using the probe on the

tooth surface.

2

Moderate accumulation of soft deposits within the gingival

pocket,or the tooth and gingival margin which can be seen

with the naked eye.

3

Abundance of soft matter within the gingival pocket and/or

on the tooth and gingival margin.

Gingival Index: The efficacy of the test product in supporting healthy gums was evaluated by Loe and Silness Gingival Index scoring.

Score

Condition

0

Absence of inflammation

1

Mild inflammation; slight change in color and little

change in texture. No bleeding on probing

2

Moderate inflammation; moderate glazing, redness,

Oedemaand hypertrophy; bleeding on sensing

3

Severe inflammation; marked redness and oedema;

tendency to spontaneous bleeding; ulceration

4

Permanent and primary tooth missing

VITA shade assessment: The efficacy of the test product variant in white teeth VITA Shade for evaluating whiter teeth:

The VITA classical A1 – D4 shade guide serves to accurately determine tooth shade. The arrangement of the shades in the VITA classical family of shades is as follows:

A1 - A4 (reddish-brownish)

B1 - B4 (reddish-yellowish)

C1 - C4 (greyish shades)

     D2 - D4 (reddish-grey)

Buccal irritation: The scoring will be done as per the below described procedure.

The scoring will be performed through monitoring of the specific areas of oral cavity as per the Table below.

Buccal Irritation Scoring

Areas of oral cavity

Irritation Grading

0

1

2

3

Buccal mucosa

 

 

 

 

Labial mucosa

 

 

 

 

Sublingual mucosa

 

 

 

 

Mucobuccal fold

 

 

 

 

Gingiva

 

 

 

 

Tongue

 

 

 

 

Hard and soft palate

 

 

 

 

 

The dental examiner will rate the irritation/inflammation on the soft tissues using below scale;

  • 0=none (normal),
  • 1=erythema plus slight edema (mild),
  • 2=moderate erythema and/or edema (beginning of tissue breakdown or sloughing) (moderate),
  • 3=severe inflammation/irritation (definite blistering, ulceration, or epithelial sloughing) (severe).

The adverse events will be recorded thorough monitoring the hard tissue / soft tissue oral health and as reported by the subject.

Subjective questionnaire evaluations:

The efficacy of test product in Preventing mouth odour, providing of Mouth freshness upto X hours, maintain clean and healthy mouth and providing fresh breath through subjective questionnaire. 
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