CompletedNot Applicable

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

Egypt33 participantsStarted 2022-01-01

Plain-language 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.

Who can participate

Age range

4 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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...

Trial details

NCT IDNCT06174194

SponsorFaculty of Dental Medicine for Girls

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-08-10

View on ClinicalTrials.gov More Dental Caries in Children trials