Will application of star anises help in improvement of various properties like antimicrobial, anti-inflammatory and astringent in oral cavity or not?

Phase 1

Not yet recruiting

Conditions: Subjects free from systemic diseases and allergy, having moderate gingival and fair plaque scores according to the indices proposed by Silness and Loe and those signed the consent form were selected.

Registration Number: CTRI/2017/08/009398

Lead Sponsor: Surendera Dental College and Research Institute Sriganganagar

Brief Summary: Dental disease prevention is commonly associatedwith a reduction of some gram positive and gram negative microorganism. Presentlyno such study is available regarding the in vivo effect of star anise.

The primary outcome measure used for this study willbe to determine anti-inflammatory property and astringent property by Loe andSilness Gingival Index and papillary bleeding index respectively. The indiceswill be measured at baseline, 14th day and after 28 days ofadministration of the mouthwash. Afterevaluating the findings in 28 days, they will be made to undergo completeultrasonic scaling.

Antimicrobial activity: Subjects will be madecomfortable and asked to rinse mouth with normal tap water. They will be askedto spit their saliva into the sterile plastic containers. About 3â€“4 ml of wholeunstimulated saliva will be collected over 2 min. All the saliva samples of participantswill be coded during the period of sample collection and processing. Thesamples collected will be handed over to the pathology laboratory for analysison the same day. In the laboratory, samples will be stored at room temperature(17Â°Câ€“25Â°C) prior to the analysis.

All samples will be sonicated (Vibra Cell 400 W,Sonics & Materials Inc. â€“ 5% amplitude, 9.9 s cycle, six pulses) anddiluted in a saline solution (100 and 1000 times). The diluted samples (5 *u*l) will then spread on blood agar. ThePetri dishes will be placed in an incubator (Jovan IG 150) with 10% CO2at 37Â°C for 48 hours. Subsequently, the dishes with blood agar will be placedin an aerobic incubator at 37Â°C, for an additional 24 hours. Total oralmicroorganism counts will be performed in blood agar. Bacterial colonies willbe enumerated and the number of viable bacteria reported as colony formingunits per ml (CFU/ml).

Thus,the aim of this study is to observe the antimicrobial activity of star anise against oral microorganism and to testthe efficacy of star anise as astringent and anti-inflammatory agent.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Fifteen healthy subjects between the age group of 18-35 years.
Subjects having all teeth and presenting no allergy were selected.
Free from systemic diseases.
Subjects having moderate gingival scores and fair plaque scores according to the plaque and gingival indices proposed by Silness and Loe and Loe and Silness, respectively.
All the index teeth should be completely erupted.
Should not have used mouthwashes for the last 1 month.
Currently non-smokers.
Subjects formally agreed with all study aspects and signed the consent form.

Exclusion Criteria

Subjects who had been on medication in the last 6 months.
Suffering from any diseases which might affect the salivary flow.
History of antibiotic therapy in the previous 1 month till the start of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Gingival health and reduction in salivary microbial count	28 days

Secondary Outcome Measures

Name	Time	Method
Improvement in gingival inflammation and microbial count	28 days

Trial Locations

Locations (1): Surendera Dental College and Research Institute, Sriganganagar
🇮🇳
Ganganagar, RAJASTHAN, India
Surendera Dental College and Research Institute, Sriganganagar
🇮🇳Ganganagar, RAJASTHAN, India
Mankirat Kaur Gill
Principal investigator
8740974778
kiratkaurgill@hotmail.com