To evaluate the effect of tulsi leaf extract containing gel in treating patients with gum disease

Phase 3

Completed

• Conditions: Other general symptoms and signs,

• Registration Number: CTRI/2018/01/011175
• Lead Sponsor: Dr Anupa Jankish

Brief Summary

study hypothesis : to test the efficacy of a herbal based (tulsi leaf extract) gel in addition to standard oral hygiene practice in patients with moderate to severe gingivitis

A total of 60 systemically healthy patients diagnosed with chronic generalised gum infection will be included. Complete oral examination along with clinical parameters and plaque samples will be taken, after which all patients will undergo thorough oral prophylaxis (cleaning of teeth). After this they will be randomly allocated into any of the three groups. of which one group will receive the experimental tulsi gel (test group), second group will get chlorhexidine gel (control group) and the third group will get a placebo gel (placebo group). instructions on usage of the gel and oral hygiene instructions will be given to the patient. the patient will be recalled for follow up at 15 days and 3 months. during the initial and follow up visits complete oral examination will be done along with collection of plaque samples for clinical and microbiological analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 2019-04-11
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.presence of a minimum of 24 functional teeth 2.patients with moderate to severe form of gingivitis 3.patients withtin the age group of 18-45 years.

Exclusion Criteria

• 1.Subjects with removable or fixed orthodontic appliances or prosthesis.
• 2.Subjects who have been prescribed antibiotics or anti-inflammatory drugs in the past 3-6 months 3.Patients with any systemic involvement 4.Subjects with any reported allergy 5.Subjects with any tobacco related habits 6.
• Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The antimicrobial and anti-gingivitis effect of tulsi leaf extracr based gel will be evaluated by assesssing the plaque samples and improvement in the clinical parameters	recall intervals of 15 days and 3 months

Secondary Outcome Measures

Name	Time	Method
plaque index	gingival index

Trial Locations

Locations (1)

Manipal College of Dental Sciences; 🇮🇳 Udupi, KARNATAKA, India

Manipal College of Dental Sciences

🇮🇳Udupi, KARNATAKA, India

Dr Anupa Jankish

Principal investigator

9916409716

anupajankish70@gmail.com