EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL

EFFICACY OF PROBIOTIC, CHLORHEXIDINE AND SODIUM FLUORIDE MOUTHRINSES ON MUTANS STREPTOCOCCI IN 8 TO 12 YEAR OLD CHILDREN - A RANDOMIZED CONTROLLED TRIAL - Efficacy of Probiotic, Chlorhexidine and Sodium Fluoride Mouthrinses on Mutans Streptococci in Children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042958

Enrollment

Registered

2021-01-09

Start date

2017-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children suffering from dental caries between ages of 8 to 12 years.

Interventions

1st phase: Use of 10 ml of allocated mouthrinse by all three groups twice a day for 2 weeks followed by washout period of 4 weeks. 2nd phase: Use of 10 ml of allocated mouthrinse by all three groups

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children who had completed 8 years on or before 1 st January 2017 and were to complete 12 years on or after 28 th February 2017. 2. ASA category I children. 3. Children who could visit the department for a regular follow up. 4. Children with a Total Caries Score (dmft + DMFT) [d/D-decay, m/M-missing, f/F-filled teeth] [primary + permanent dentition] between four and ten.

Exclusion criteria

Exclusion criteria: 1. Children with a history of recent or ongoing antibiotics. 2. Children undergoing orthodontic treatment or using a prosthesis. 3. Children who could not brush or rinse on their own. 4. Children with any soft tissue intra-oral pathology. 5. Habitual consumption of Probiotics for dental or medical purposes. 6. Children in whom saliva collection was not possible due to physical/medical/mental handicap. 7. Children whose parents or legal guardians did not give informed consent and the child did not give assent.

Design outcomes

Primary

Measure	Time frame
The independent variables assessed were: A. Treatment (type of mouthrinse) 1. Probiotic powder 2. 0.2% Chlorhexidine 3. 0.05% Sodium Fluoride B. Cycle (sequence of drug administration) The dependent variables assessed were: 1. Number of MS colonies grown on Mitis Salivarius Bacitracin agar.	—

Secondary

Measure	Time frame
Confounding (co-variables) variables considered in the analysis were: 1. Age (8 to 10 and 10 to 12 years) 2. Gender	—

Countries

Asia(except Japan)

Contacts

Public ContactAMAR KATRE

YMT Dental College and Hospital Department of Pediatric and Preventive Dentistry

amar_katre@hotmail.com+91-22-27744429

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026