Safety & Efficacy of HDNT-072012

Phase 3

Not yet recruiting

Brief Summary: This is a prospective, open label, clinical study to evaluate the oral mucosal safety and efficacy of test product in 40 healthy adult subjects. The subjects were asked to make use of the test product for 6 weeks.

The following clinical assessments will be carried out by the Investigator

The clinical efficacy assessment will be carried out through:

1. Plaque index

2. VITA Shade

3. Gingival index

4. Subjective questionnaire

Safety assessment:

1. Buccal irritation scoring as safety parameter

2. Adverse event reporting

These assessments could be used to evaluate the oral hygene of the the participants before and after the study thus proving the safety and efficacy of the test product.

Recruitment & Eligibility

Inclusion Criteria

1.Subjects with age group 18 years to 60 years in general good health and oral health.
2.Subjects willing to provide consent to the study 3.Subjects with moderate oral hygiene and adhering to basic habits like using standard toothbrush and toothpaste 4.No history of any clinically significant medical condition 5.No recent history (past 3 months) of overall oral/gum bleeding disorders 6.No history of any medical problems requiring hospital care.
7.Willing to abide by and comply with the study protocol.
8.Available to comply the study procedure for the entire duration of the study.
9.Should not have participated in a similar clinical study in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study.

Exclusion Criteria

1.A known history or present condition of hyper sensitivity 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 device such as a removable partial denture or orthodontic retainer.
8.The presence of any large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth.
9.Having intrinsic dental stains.
10.Having abnormal frenum attachment.
11.Having moderate to severe level of calculus and/ tartar.
12.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.
13.Suffering from any form of systemic illness, oral infections, hospitalizations and pharmacological treatment.

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of test product in	1.Screening and baseline visit(day1) \| 2.Visit 2(Day 15) \| 3.Visit 3(Day 45)/End of study visit
preventing plaque build-up evaluated through plaque index, improving gum health evaluated through Gingival index by dentist, teeth whitening effect of test product as evaluated by VITA shade card	1.Screening and baseline visit(day1) \| 2.Visit 2(Day 15) \| 3.Visit 3(Day 45)/End of study visit

Secondary Outcome Measures

Name	Time	Method
Evaluation of preventing mouth odour, providing of Mouth freshness, maintain clean and healthy mouth, providing Long lasting fresh breath through subjective questionnaire, safety of test product by buccal irritation score and subject reported adverse events	1.Screening and baseline visit(day1)

Locations (1): Trilkamal Dental Clinic
🇮🇳
Bangalore, KARNATAKA, India
Trilkamal Dental Clinic
🇮🇳Bangalore, KARNATAKA, India
Dr Suhas Prabhakar
Principal investigator
9739325771
suhasprabs.y2k@gmail.com