Clinical study of herbal toothpaste to check the efficacy against gum problems

Phase 3

Not yet recruiting

Conditions: Chronic gingivitis. Ayurveda Condition: à¤¶à¥€à¤¤à¤¾à¤¦à¤ƒ (Gingivitis / Spongy Gums),

Brief Summary: Summary:

The objective of this clinical research study is to evaluate the efficacy of aâ€‹ toothpaste containing herbal ingredients on established â€‹dental â€‹plaque and gingivitis in adults. This is a phase III, single center, randomised, parallel and double blinded study conducted on about 100 subjects in the age group between 25 to 70 years.

The subjects will be exposed to either of 2 different test products for a period of 6 months with a treatment regimen of whole mouth brushing twice daily for 2 minutes.

Recruitment & Eligibility

Inclusion Criteria

Potential subjects must meet ALL of the following criteria: Males and females, between 25-70 years of age; Informed Consent Form signed and availability for the duration of the study; Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
Examples include heart problems, valve/hip replacements, etc); Willingness to provide information related to their medical history and a negative Covid-19 test via RT PCR or a Rapid Antigen test within 48 hours prior to site visits; Minimum of 10 uncrowned permanent natural teeth (excluding third molars); Initial mean gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index and at least 10% of bleeding sites; Availability for the duration of the study.

Exclusion Criteria

Potential subjects must NOT HAVE ANY of the following conditions: Oral pathology, chronic disease, or a history of allergy to testing products; Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; Subject participating in any other clinical study that might interfere with the main study outcome; Subject pregnant or breastfeeding; Subject allergic to oral care products, personal care consumer products, or their ingredients; Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study; Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine); Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Pocket depth greater than 4 mm, periodontal abscess(es), teeth with mobility > 1; Current smokers, tobacco users and subjects with a history of alcohol or drug abuse; An existing medical condition which prohibits eating or drinking for periods up to 4 hours.

Primary Outcome Measures

Name	Time	Method
Gingivitis (Loe and Silness Gingival Index and Ayurveda 3 parameters)	Baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Quigley-Hein Plaque Index	Baseline, 3 months and 6 months

Locations (1): Global Health Research Group
🇮🇳
South, DELHI, India
Global Health Research Group
🇮🇳South, DELHI, India
Dr Ashish Kakar
Principal investigator
91981140353
ashish@ghrg.org