Dental CariesNCT07828171
Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children.
A study testing Mouth wash in people with Dental Caries and Streptococcal Infections, run by British University In Egypt at 1 site in Egypt.
Trial summary
A randomized controlled trial that compares the antibacterial effectiveness of three mouthwashes-licorice, clove, and chlorhexidine-in Egyptian children aged 7-12 years. The main focus is Streptococcus mutans, one of the main bacteria associated with dental caries. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Dental Caries, Streptococcal Infections, Mouthwashes
- What is being tested?
- Mouth wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with high caries index based on CAMBRA.
- Frankl scale 3 and 4 (cooperative).
Who cannot join
- Patients with teeth showing signs of infection (abscess or fistula)
- Patients with mucositis (can't be given alcohol containing mouthwashes)
- Hypertensive patients.
- Allergic patients.
- Special health care patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children: Randomized Controlled Trial.
A randomized controlled trial that compares the antibacterial effectiveness of three mouthwashes-licorice, clove, and chlorhexidine-in Egyptian children aged 7-12 years.
The main focus is Streptococcus mutans, one of the main bacteria associated with dental caries. The saliva samples will be collected from the children and the amount of S. mutans will be measured before and after using the assigned mouthwash.
Read more
The children will be randomly divided into groups, with each group receiving one of the three mouthwashes. The bacterial counts will then be compared to determine which mouthwash is most effective at reducing salivary S. mutans.
The research question is whether natural mouthwashes made from licorice or clove reduce the bacteria that cause cavities as effectively as chlorhexidine in children?
The study could help determine whether licorice and clove are effective natural alternatives or adjuncts to chlorhexidine, particularly considering that chlorhexidine can have undesirable effects with prolonged use.
Overall aim: Compare and evaluate the antibacterial efficacy of the three mouthwashes
- Conditions
- Dental Caries, Streptococcal Infections, Mouthwashes
- Being tested
- Mouth wash
- Medical subject headings
- Dental Caries, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth washOther
The interventions will consist of three different mouthwashes: licorice mouthwash, clove mouthwash, and 0.2% chlorhexidine mouthwash. Each participant will use the mouthwash assigned to their study group according to the standardized study protocol. The herbal mouthwashes will be prepared using standardized licorice and clove extracts at predetermined concentrations, while the chlorhexidine group will receive 0.2% chlorhexidine mouthwash as the positive control. All mouthwashes will be provided in identical, appropriately labeled containers to maintain blinding where applicable. The interventions will be distinguished by their active ingredient and concentration, while the method, frequency, duration of use, and volume administered will be standardized across all groups.
| Study group | Role | What they receive |
|---|---|---|
| Chlorohexidine Mouthwash | Active comparator | Not described Receives: Other: Mouth wash |
| Clove mouthwash | Experimental | Not described Receives: Other: Mouth wash |
| Licorice mouthwash | Experimental | Not described Receives: Other: Mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of dental caries incidence in high-caries index pediatric patients using International Caries Detection and Assessment System.
Measured: Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.
Secondary outcomes (3)
The reduction in Streptococcus mutans count following the use of licorice and clove mouthwashes in Egyptian pediatric patients aged from 7 to 12.
Measured: Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.
Patient reported satisfaction, regarding the taste using a questionnaire.
Measured: Through study completion, an average of 3 months.
Adverse events related to the use of the licorice and clove mouthwashes, regarding oral irritation and allergies using a questionnaire.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start6 Oct 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PG NADINE, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828171
- Sponsor's protocol ID
- 24-029
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07828171
- Acronym / sponsor ID
- 24-029
- Conditions
- Dental Caries, Streptococcal Infections, Mouthwashes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
A randomized controlled trial that compares the antibacterial effectiveness of three mouthwashes-licorice, clove, and chlorhexidine-in Egyptian children aged 7-12 years.
The main focus is Streptococcus mutans, one of the main bacteria associated with dental caries. The saliva samples will be collected from the children and the amount of S. mutans will be measured before and after using the assigned mouthwash.
The children will be randomly divided into groups, with each group receiving one of the three mouthwashes. The bacterial counts will then be compared to determine which mouthwash is most effective at reducing salivary S. mutans.
The research question is whether natural mouthwashes made from licorice or clove reduce the bacteria that cause cavities as effectively as chlorhexidine in children?
The study could help determine whether licorice and clove are effective natural alternatives or adjuncts to chlorhexidine, particularly considering that chlorhexidine can have undesirable effects with prolonged use.
Overall aim: Compare and evaluate the antibacterial efficacy of the three mouthwashes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorohexidine Mouthwash | Active comparator | Other: Mouth wash |
| Clove mouthwash | Experimental | Other: Mouth wash |
| Licorice mouthwash | Experimental | Other: Mouth wash |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients with high caries index based on CAMBRA.
- Frankl scale 3 and 4 (cooperative).
Key exclusion criteria (5 listed)
- Patients with teeth showing signs of infection (abscess or fistula)
- Patients with mucositis (can't be given alcohol containing mouthwashes)
- Hypertensive patients.
- Allergic patients.
- Special health care patients.
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 |
|---|---|---|
| Mouth washThe interventions will consist of three different mouthwashes: licorice mouthwash, clove mouthwash, and 0.2% chlorhexidine mouthwash. Each participant will use the mouthwash assigned to their study group according to the standardized study protocol. The herbal mouthwashes will be prepared using standardized licorice and clove extracts at predetermined concentrations, while the chlorhexidine group will receive 0.2% chlorhexidine mouthwash as the positive control. All mouthwashes will be provided in identical, appropriately labeled containers to maintain blinding where applicable. The interventions will be distinguished by their active ingredient and concentration, while the method, frequency, duration of use, and volume administered will be standardized across all groups. | Other | Chlorohexidine Mouthwash, Clove mouthwash, Licorice mouthwash |
Primary outcome
Reduction of dental caries incidence in high-caries index pediatric patients using International Caries Detection and Assessment System.
Time frame: Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.
3 secondary outcomes
The reduction in Streptococcus mutans count following the use of licorice and clove mouthwashes in Egyptian pediatric patients aged from 7 to 12.
Time frame: Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.
Patient reported satisfaction, regarding the taste using a questionnaire.
Time frame: Through study completion, an average of 3 months.
Adverse events related to the use of the licorice and clove mouthwashes, regarding oral irritation and allergies using a questionnaire.
Time frame: Through study completion, an average of 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth wash in people with Dental Caries and Streptococcal Infections, run by British University In Egypt 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 2 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction of dental caries incidence in high-caries index pediatric patients using International Caries Detection and Assessment System. (time frame: Baseline(Day 1), 2 weeks postoperative, then 3 months postoperative.). 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 Sep 2026.