Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children

NCT06174194 | Completed

• 1 other identifier: REC-PE-23-14
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to explore how adding Tulsi extract, a natural plant substance, to chewing gum affects the levels of Streptococcus mutans, type of bacteria that cause dental caries, in the saliva of children aged 4 to 11 years. Participants should not use removable prosthetics or orthodontic appliances and had had not used antibiotics in the 2 weeks preceding sample collection. We want to answer this main question: Can chewing gum with Tulsi extract significantly reduce the number of Streptococcus mutans bacteria in children's saliva? Participants tasks:

• Children were asked to chew gum containing Tulsi extract for 5 minutes and then dispose of the gum.
• Two salivary samples were collected from each child: one before gum chewing and another 30 minutes after disposing the gum. Researchers compared Streptococcus mutans counts in saliva before and after gum chewing to determine if there is a significant reduction in bacterial colonies.

Conditions

Dental Caries in Children

Keywords

caries prevention; streptococcus mutans

Outcome Measures

Primary Outcomes (1)

• Salivary Streptococcus mutans Count

  The primary outcome measure involves assessing the count of Streptococcus mutans colonies in salivary samples. This count serves as a metric for evaluating the antimicrobial effect of Tulsi Gum on dental caries prevention in children.

  Assessment will be conducted at two specific time points for each participant: Before commencing gum chewing, and after 30 minutes following the conclusion of chewing Tulsi Gum for 5 minutes...

Study Arms (1)

Tulsi Gum Arm

EXPERIMENTAL

All participants were instructed to masticate gum containing Tulsi extract for a duration of 5 minutes and subsequently discard the gum. Salivary samples were collected before commencing gum chewing and after 30 minutes following the conclusion of chewing gum for 5 minutes.

Dietary Supplement: Tulsi Gum

Interventions

Tulsi Gum DIETARY_SUPPLEMENT

The intervention involves participants chewing a specially formulated gum known as "Tulsi Gum" for 5 minutes. Tulsi Gum contains Tulsi extract, a natural substance derived from the Tulsi plant. This extract is recognized for its potential antimicrobial properties. Participants are then required to discard the gum. The study aims to assess the effect of Tulsi Gum on salivary Streptococcus mutans count in children aged 4 to 11 years. This assessment contributes to understanding the potential of Tulsi Gum in preventing dental caries in children.

Tulsi Gum Arm

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 4 and 12 years old.
• No fixed or removable orthodontic appliances or removable prostheses.
• Systemically healthy patients.
• No history of recent antibiotic administration (previous 2 weeks).

You may not qualify if:

• History of using antimicrobial mouthwash (previous 12 hours).
• History of fluoride treatment (previous 2 weeks).

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Faculty of Dental Medicine Azhar University

Cairo, 1871, Egypt

Location

Study Officials

• somaya MA Kahwa, Dr

  Faculty of Dental Medicine for Girls

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 1, 2022
• Primary Completion: August 10, 2022
• Study Completion: October 10, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)