An Open Label Clinical Study to Evaluate The Oral Mucosal Safety and Efficacy of HBHT-102110 in Healthy Adult Subjects

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 Mouthfreshness upto X hours, maintain clean and healthy mouth and providing freshbreath through subjective questionnaire.