A clinical study to assess safety and effectiveness of toothpaste in healthy adult subjects

Phase 2

Not yet recruiting

Conditions: Healthy adult volunteers

Registration Number: CTRI/2022/07/043641

Lead Sponsor: Himalaya wellness company

Brief Summary: This is a prospective, open label,clinical study to evaluate the oral mucosal safety and efficacy of test product in healthyadult subjects.

As this is an open-label study, the studyinvestigator, trial subjects and the study staff will be aware of theinterventions.

Followingprovision of informed consent and completion of all screening assessments,eligible subjects will receive the test product. Thetotal 40 subjects are expected to complete the study. The subjects will beevaluated on day 1 (Pre and Post use of test product), day 15, day 30 and day 45(end of study).

Beforethe start of the study all subjects will be given instructions for oralhygiene, and usage of the products, rinsing time and technique. Subjects willbe instructed to rinse their mouth twice daily, in the morning after brushingand in the evening before sleeping. All subjects will be asked to avoid eating/drinking foodfor 30 minutes before the clinical evaluations.

Alongwith the test product, all subjects will receive instructions for usage of theproduct and questionnaires. The study duration is of 6 weeks, during which, thesubjects will be instructed to rinse their teeth twice daily with the testproduct. The subjects will undergo safety and efficacy assessments at Day 1,Day 15, Day 30 and Day 45.

AllAEs will be followed until resolution or deemed stable or until the event isfound to be due to another known cause (concurrent condition or medication) andclinical judgment indicates that further evaluation is not warranted. Should anInvestigator be made aware of any serious AE (SAE) occurring any time after theactive reporting period, the SAE (in case of reasonable causality) will bereported to Sponsor within 24 hours.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

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 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. To determine efficacy in Preventing mouth odour, providing of Mouth freshness upto X hours, fresh breath throughout the day, X hours fresh breath, maintain clean and healthy mouth evaluated through subjective self-administered questionnaire.	Day 1, day 15 , day30, day 45
. To determine the efficacy of test product in preventing plaque build-up by using Silness and Loe plaque index	Day 1, day 15 , day30, day 45
. To determine the efficacy of test product in improving gum health by using Loe and Silness Gingival Index	Day 1, day 15 , day30, day 45

Secondary Outcome Measures

Name	Time	Method
4.To determine the safety of test product by buccal irritation score and subject reported adverse events.	Day 1, day 15 , day30, day 45

Trial Locations

Locations (1): Dr Tooth Cosmetic and Advanced Dental centre
🇮🇳
Bangalore, KARNATAKA, India
Dr Tooth Cosmetic and Advanced Dental centre
🇮🇳Bangalore, KARNATAKA, India
Dr Ranadheer
Principal investigator
8867125414
ranadheer.ramachandra@gmail.com