comparing the efficiency of various mouthrinses on streptococcus mutans count in children having caries

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/12/010895
• Date of registration: 15-12-2017
• Prospective Registration: No
• Primary sponsor: Institute of Dental Studies and Technologies
• Public title: comparing the efficiency of various mouthrinses on streptococcus mutans count in children having caries
• Scientific title: To compare the effectiveness of different mouthrinses on Streptococcus mutans count in caries active children
• Date of first enrolment: 11-02-2016
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21209
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Nidhi Agarwal Guide
• Affiliation: Institute of Dental Studies and Technologies

• Name: Aakansha Sharma
• Affiliation: Institute of Dental Studies and Technologies

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy children between ages of 6-12 years.

2. Patient having one or more than one interproximal carious lesions, well into the dentin, visualized radiographically.

3. All teeth and surrounding tissues were clinically and radiographically free of any other pathologic condition


Exclusion criteria: 1. Physical limitations, which might preclude the normal tooth brushing and mouth rinsing.

2. Presence of any intraoral infections.

3. Medically compromised patients or those who were on any long term medication.

4. Subjects with history of taking antibiotics 1 month prior to or during the course of study.

5. Patient reporting with pain or history of pain requiring immediate treatment.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- caries active children

Intervention(s)

Intervention1: INTERVENTION 1- Chlorhexidine mouthrinse (Hexidine): Chlorhexidine gluconate (CHX) is a cationic bisbiguanide a broad- spectrum antibacterial agent that acts against gram-positive and gram-negative bacteria as well as yeasts, spores, lipophilic viruses, and dermatophytes
Intervention2: Intervention 2-Herbal mouthrinse (Hiora): The ingredients of this mouthwash are-
1. Pilu (Salvadora persica)
2. Nagavalli (Piper betel)
3. Bibhitaki (Terminalia bellerica)
4. Gandhapura taila (Gaultheria fragrantissima)
5. Ela (Elettaria cardomum)
6. Peppermint satva (Mentha Piperita)
7. Yavanisatva (Tachyspermum ammi)

Intervention3: Intervention 3- sodium fluoride mouthwash (Fluoritop): Sodium fluoride is a chemical agent that is made up of cationic sodium and anionic fluoride molecules.Fluoride displays its bacteriostatic properties by many pathways. It blocks an enzyme of the glycolytic pathway, enolase. Subsequently, inhibition of carbohydrate uptake by oral microbes via PEP (phosphoenolpyruvate) dependent phosphotransferase system (PEP-PTS) occurs.
Intervention4: Intervention 4- Water: water acted as the control group
Control Intervention1: Not applicable: Not applicable

Primary Outcome(s)

Reduction in streptococcus mutans levelTimepoint: Baseline and 15 days

Secondary Outcome(s)

Not applicableTimepoint: Not applicable

Secondary ID(s)

NIl

Source(s) of Monetary Support

Nil

Ethics review

Status: Approved
Approval date: 02/11/2015
Contact:

Institutional ethical committee

Results

• Date Completed: 11/10/2016