Dental Caries in ChildrenNCT06174194
Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children
A study testing Tulsi Gum in people with Dental Caries in Children, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Tulsi Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- History of using antimicrobial mouthwash (previous 12 hours).
- History of fluoride treatment (previous 2 weeks).
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Dental Caries in Children
- Being tested
- Tulsi Gum
- Keywords
- caries prevention, streptococcus mutans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tulsi GumDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Tulsi Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jan 2022
- Primary completion10 Aug 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Somaya Mohsena Anwar, Faculty of Dental Medicine for Girls
- Investigators
- somaya MA Kahwa, Dr, Principal investigator, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174194
- Sponsor's protocol ID
- REC-PE-23-14
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children
- ClinicalTrials.gov ID
- NCT06174194
- Acronym / sponsor ID
- REC-PE-23-14
- Conditions
- Dental Caries in Children
- Keywords
- caries prevention, streptococcus mutans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tulsi Gum Arm | Experimental | Dietary Supplement: Tulsi GumAll 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. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- History of using antimicrobial mouthwash (previous 12 hours).
- History of fluoride treatment (previous 2 weeks).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tulsi GumThe 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. | Dietary supplement | Tulsi Gum Arm |
Primary outcome
Salivary Streptococcus mutans Count
Time frame: 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...
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
somaya MA Kahwa, Dr principal investigator
Faculty of Dental Medicine for Girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tulsi Gum in people with Dental Caries in Children, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Streptococcus mutans Count (time frame: 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...). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.