Comparing the effect of topical fluorides on salivary bacteria streptococcus mutans levels and salivary pH in children with early childhood caries

Phase 2/3

Not yet recruiting

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2025/05/087691
• Lead Sponsor: Dr Ganavi G Nayak

Brief Summary

A total of 45 children who meets the inclusion criteria will be  selected for the study and grouped as follows. Group 1 ( n=15), Group 2( n=15), Group 3( n=15). All subjects will be instructed to refrain from eating and drinking for 1 hour before the saliva sample collection. Pre-intervention unstimulated saliva sample will be collected by spitting method. The patients will be asked to rinse the mouth with filter water twice before the collection. After the oral rinse, Children will be asked to spit the saliva into sterile tubes for a period of 5 min. Then, these tubes will be sealed immediately after sample collection and refrigerated at -20 degree Celsius and stored in laboratory until further analysis. Group I children are treated with MI varnish, Group II with 38% SDF and Group III with NSF   respectively with micro brush and left for 2minutes.Post application instructions will be given. Children are recalled after 1 month and 3 month from the day of application and post -intervention saliva samples will be collected by same procedure as mentioned above and all the samples are subjected to lab to determine the salivary  pH  and S.mutans levels. The results obtained will be subjected to statistical analysis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-26
• Study Start: 2025-09-06

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Children with 3 to 6 years of age of both genders 2.Children with DC greater than or equal to 3 in primary teeth, ICDAS II criteria , CODE 02 and 03 3.
• Parents giving consent for the study.

Exclusion Criteria

• Children who received fluoride topical application during the last 1 month 2.
• Children requiring special health care needs.
• 4.Children who were on antibiotic therapy within the past 3 months.
• 5.Children with genetic diseases or syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate salivary streptococcus mutans levels and salivary pH before and after application of MI varnish,38% SDF and NSF in children with ECC using ELISA	Base line | 1 month | 3 month

Secondary Outcome Measures

Name	Time	Method
Correlation and comparision of intragroup and intergroup salivary streptococcus mutans level and salivary pH levels before and after application of MI varnish,38% SDF and NSF in childrden with ECC using ELISA	Base line

Trial Locations

Locations (1)

Rajarajeswari dental college and hospital; 🇮🇳 Rural, KARNATAKA, India

Rajarajeswari dental college and hospital

🇮🇳Rural, KARNATAKA, India

Dr Ganavi G Nayak

Principal investigator

07624908255

ganavinayak18@gmail.com