Comparision of Rice husk extract mouthwash and Kidodent mouthwash in children

Not yet recruiting

• Conditions: Healthy Volunteers of age group 8-12 years and No abnormality detected

• Registration Number: CTRI/2020/10/028594
• Lead Sponsor: Dr B Neha

Brief Summary

**Background:**Dental Caries is attributed to the Streptococcus mutans in the oral cavity. Rice husk is the byproduct of rice milling it is of great benefit to both the economy and environment to effectively convert rice husk into valuable products. The presence of antioxidant activity, phenolic compounds, flavonoid contents, gamma-oryzanols, and tocopherols, in greater amounts in the external layers; thus, the bran and husk fractions demonstrated a higher antioxidant activity (Butsat & Siriamornpun, 2010). Therefore preparation of the mouthwash  out of this product could be of a great benefit.

**Aim**: The purpose of the study is to evaluate and compare the effectiveness of Rice husk extract mouthwash and Kidodent mouthwash for reduction in Salivary Streptococcus Mutans count.

**Materials and Methodology:**45 children who meet the inclusion criteria will be assigned into 3 groups randomly by lottery method and concealed allocation is to be done with both participant and the examiner blind. In Group A, children will reveive rice husk mouth wash whereas in Group B placebo is given and in Group C comparator Kidodent mouthwash will be given. The unstimulated saliva should be collected at baseline, 7th , 10th and 15th day and subjected to microbiological analysis to check for the reduction of Streptococcus mutans.

The collected data will be statistically analysed using one-way Anova and repeated measures Anova.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-10-22
• Study Start: 2020-10-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Children with good general health, 2) Children devoid of infectious diseases.

Exclusion Criteria

1. Children who cannot expectorate completely, 2) History of taking antibiotics one month before and amidst clinical trial, 3) Children receiving orthodontic treatment or with any kind of oral prosthesis, 4) Presence of any intra oral pathology, 5) Children not available for follow up phase and children who are using any oral hygiene aids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of rice husk mouthwash in comparision to Kidodent mouthwash in reduction of Streptococcus mutans level	Baseline, 7th day, 10th day and 15th day

Secondary Outcome Measures

Name	Time	Method
Evaluate for any malodour after the use of rice husk mouthwash	Everyday throughout the study period
To evaluate the efficacy of rice husk mouthwash in reduction of Streptococcus mutans level over the period of 15 days.	Baseline, 7th day, 10th day and 15th day

Trial Locations

Locations (1)

Morarji Desai Residential School; 🇮🇳 Raichur, KARNATAKA, India

Morarji Desai Residential School

🇮🇳Raichur, KARNATAKA, India

Dr B Neha

Principal investigator

7989966383

shreya.bemalgi@gmail.com