Comparative assessment of the anti-cavity effectiveness of Makandi root extract, cranberry extract and magnetized water as mouth washes in 6-12 years old children

Completed

• Conditions: Human volunteers visiting the pediatric dental OPD

• Registration Number: CTRI/2021/07/034954
• Lead Sponsor: Self Dr Mangetri Fasale

Brief Summary

INTRODUCTION - Chlorhexidine is still the gold standard mouthrinse for its antimicrobial action and high substantiveness, but side effects, such as pigmentation, taste alteration, and the formation of supragingival calculus limit its continued use. The less availability and unaffordable cost of new generation antibiotics initiated to look for alternative phytomedicine to discover plant derived constituents with claimed antimicrobial activity. AIM - To evaluate *in vivo* and to compare the anti-cariogenic efficacy of *Coleus forskohlii* rootextract*,* Cranberry extract and magnetized water as mouthrinses by analysing pH and buffering capacity of saliva and *Streptococcus mutans* count in 6-12 years old children METHODOLOGY - This study is a prospective randomized controlled, parallel group, multiple arm trial consisting of 120 children between the age group of 6-12 years, who are willing to participate in the study. The children will be selected according to the inclusion and exclusion criteria and randomly allocated to the study and control groups. They will be asked to rinse with the mouth rinse for about 60 seconds and unstimulated saliva will be collected pre-rinse as well as 10 minutes, 30 minutes and 60 minutes after rinsing and the pH and buffering capacity of saliva and *Streptococcus mutans* count of the same will be evaluated. EXPECTED CONCLUSION - It is expected that *Coleus forskohlii*rootextract*,*Cranberry extract and magnetized water show similar efficacy as that of chlorhexidine mouthrinse and can be effectively used as an alternative to it.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study Completion: 2022-01-28
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Systemically healthy patients 2.
• No fixed or removable orthodontic appliance or removable prosthesis 3.
• No history of antibiotics in the previous 1 month 4.
• No history of use of any mouthwash 5.
• No history of oral prophylaxis done for at least 3 months prior to the study 6.
• Mixed dentition period.

Exclusion Criteria

• 1.Patient with abscess, draining sinus, cellulitis or other conditions requiring emergency medical treatment.
• 2.Patient with severe malalignment of teeth.
• 3.Patient with medical or pharmacological history.
• 4.History of fluoride treatment in past 2 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coleus forskohlii root extract, Cranberry extract and magnetized water may show similar efficacy as that of chlorhexidine mouthrinse i.e 68% approximately and can be effectively used as an alternative to it. All three parameters are the primary outcome measures.	0 minutes, 10 minutes, 30 minutes, 60 minutes

Secondary Outcome Measures

Name	Time	Method
All three salivary buffering capacity, salivary pH and salivary S. mutans count are primary outcome measures and there will be no secondary outcomes.	NIL

Trial Locations

Locations (1)

Pacific Dental College and Hospital; 🇮🇳 Udaipur, RAJASTHAN, India

Pacific Dental College and Hospital

🇮🇳Udaipur, RAJASTHAN, India

Dr Mangetri Fasale

Principal investigator

9359046242

mangetri.fasale@gmail.com