Clinical trial NCT06174194: Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children
Official title: Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: caries prevention
streptococcus mutans
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2023-12-18
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: This interventional clinical trial aimed to assess the antimicrobial effect of Tulsi extract incorporated into chewing gum on the salivary Streptococcus mutans count in a group of children aged 4 to 11 years. The study enrolled 32 systemically healthy children who met specific criteria, including the absence of removable prosthetics or orthodontic appliances and no recent history of antibiotic use in the preceding 2 weeks.

Participants and Methods:

A sample of 33 children within the age range of 4 to 11 years was selected. The participants were systemically healthy, without removable prosthetics or orthodontic appliances, and had no recent history of antibiotic use in the previous 2 weeks. To standardize saliva collection conditions, samples were collected between 9-10 am in the morning. Children were instructed not to eat or drink anything (except water) 1 hour before saliva collection to maintain consistency in the samples.

Participants were then asked to spit into sterile containers as the method of saliva collection. Subsequently, they were instructed to masticate gum containing Tulsi extract for a duration of 5 minutes and discard the gum.

Two salivary samples were collected from each participant: one before commencing gum chewing and another 30 minutes after the conclusion of chewing gum for 5 minutes. The samples were streaked onto mitis salivarius agar plates and incubated at 37°C for 24 hours. Streptococcus mutans colonies were then counted to assess the change in bacterial count.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Salivary Streptococcus mutans Count
timeFrame: 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...
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine Azhar University
Study officials:
affiliation: Faculty of Dental Medicine for Girls
name: somaya MA Kahwa, Dr
role: PRINCIPAL_INVESTIGATOR
References: