Dental CariesNCT05841589
Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)
A study testing Green tea extract mouth rinse, Garlic with lime extract mouth rinse and Pomegranate extract mouth rinse in people with Dental Caries, run by omnia sayed at 1 site in Egypt.
Trial summary
the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Green tea extract mouth rinse, Garlic with lime extract mouth rinse and Pomegranate extract mouth rinse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Feb 2018to 1 Dec 2021
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- No history of systemic disease.
- Patients didn't received antibiotics for at least 3 months before and during the study
- Exclusion Criteria:• Children who can't expectorate completely or brush their teeth on their own.
- Fixed or removable orthodontic appliances.
- Children with intra oral abscess, oral lesions or gingival diseases.
- Parental consent was not acquired
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.
Read the detailed description
The present study was carried out on 84 children. Children were recruited based on certain inclusion criteria after signing a written informed consent by their parents. They were divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the child rinsed for 1 minute and plaque samples were collected from the child before and after rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed with garlic with lime extract and group (IV) the children rinsed with pomegranate extract mouth rinse with the same procedures. .child satisfaction was measured using 5-point pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5. Very poor).
All the plaque samples were collected and put in sterile test tubes containing thioglycolate as a transport media. They transferred to the microbiology laboratory within half an hour after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at 37°C. Number of bacterial colonies were counted by hand-held digital colony counter.
- Conditions
- Dental Caries
- Being tested
- Green tea extract mouth rinse, Garlic with lime extract mouth rinse, Pomegranate extract mouth rinse, Chlorhexidine mouth rinse
- Keywords
- herbal mouth rinses, Pomegranate, Caries prevention, Garlic extract, Green tea extract
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea extract mouth rinseProcedure or surgery
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Garlic with lime extract mouth rinseProcedure or surgery
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Pomegranate extract mouth rinseProcedure or surgery
herbal extracts mouth rinse that was prepared in the microbiology laboratory
Chlorhexidine mouth rinseProcedure or surgery
herbal extracts mouth rinse that was prepared in the microbiology laboratory
| Study group | Role | What they receive |
|---|---|---|
| Green tea extract mouth rinse | Experimental | group green tea extract Receives: Procedure: Green tea extract mouth rinse |
| Garlic with lime extract mouth rinse | Experimental | garlic with lime extract Receives: Procedure: Garlic with lime extract mouth rinse |
| Pomegranate extract mouth rinse | Experimental | pomegranate extract Receives: Procedure: Pomegranate extract mouth rinse |
| Chlorhexidine mouth rinse | Experimental | chlorhexidine Receives: Procedure: Chlorhexidine mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Child satisfaction was measured using a 5-point pictorial likert scale .This Facial image scale was suitable and easy way to evaluate patient satisfaction about taste, smell and willing to use the mouth rinse. Its format was graded from 1 to 5 while 1 is the most satisfied and 5 is the least satisfied
Measured: Through study completion, an average of 1 month
Secondary outcomes (1)
bacterial count
counting of Colony forming units was done by hand- held digital colony counter
Measured: 1 day after rinsing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start21 Feb 2018
- Primary completion30 Nov 2021
- Study completion1 Dec 2021
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
- Model description
- the four groups of the mouth rinses were done in parallel with each other
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- omnia sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, omnia sayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841589
- Sponsor's protocol ID
- PED18-8M
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)
- ClinicalTrials.gov ID
- NCT05841589
- Acronym / sponsor ID
- PED18-8M
- Conditions
- Dental Caries
- Keywords
- herbal mouth rinses, Pomegranate, Caries prevention, Garlic extract, Green tea extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- omnia sayedUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 3 May 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 aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.
Detailed description
The present study was carried out on 84 children. Children were recruited based on certain inclusion criteria after signing a written informed consent by their parents. They were divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the child rinsed for 1 minute and plaque samples were collected from the child before and after rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed with garlic with lime extract and group (IV) the children rinsed with pomegranate extract mouth rinse with the same procedures. .child satisfaction was measured using 5-point pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5. Very poor).
All the plaque samples were collected and put in sterile test tubes containing thioglycolate as a transport media. They transferred to the microbiology laboratory within half an hour after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at 37°C. Number of bacterial colonies were counted by hand-held digital colony counter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- the four groups of the mouth rinses were done in parallel with each other
| Arm | Type | Receives |
|---|---|---|
| Green tea extract mouth rinse | Experimental | Procedure: Green tea extract mouth rinsegroup green tea extract |
| Garlic with lime extract mouth rinse | Experimental | Procedure: Garlic with lime extract mouth rinsegarlic with lime extract |
| Pomegranate extract mouth rinse | Experimental | Procedure: Pomegranate extract mouth rinsepomegranate extract |
| Chlorhexidine mouth rinse | Experimental | Procedure: Chlorhexidine mouth rinsechlorhexidine |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- No history of systemic disease.
- Patients didn't received antibiotics for at least 3 months before and during the study
- Exclusion Criteria:• Children who can't expectorate completely or brush their teeth on their own.
- Fixed or removable orthodontic appliances.
- Children with intra oral abscess, oral lesions or gingival diseases.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Green tea extract mouth rinseherbal extracts mouth rinse that was prepared in the microbiology laboratory | Procedure or surgery | Green tea extract mouth rinse |
| Garlic with lime extract mouth rinseherbal extracts mouth rinse that was prepared in the microbiology laboratory | Procedure or surgery | Garlic with lime extract mouth rinse |
| Pomegranate extract mouth rinseherbal extracts mouth rinse that was prepared in the microbiology laboratory | Procedure or surgery | Pomegranate extract mouth rinse |
| Chlorhexidine mouth rinseherbal extracts mouth rinse that was prepared in the microbiology laboratory | Procedure or surgery | Chlorhexidine mouth rinse |
Primary outcome
patient satisfaction
Time frame: Through study completion, an average of 1 month
Child satisfaction was measured using a 5-point pictorial likert scale .This Facial image scale was suitable and easy way to evaluate patient satisfaction about taste, smell and willing to use the mouth rinse. Its format was graded from 1 to 5 while 1 is the most satisfied and 5 is the least satisfied
1 secondary outcome
bacterial count
Time frame: 1 day after rinsing
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 3 May 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.
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 Green tea extract mouth rinse, Garlic with lime extract mouth rinse and Pomegranate extract mouth rinse in people with Dental Caries, run by omnia sayed 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 6 inclusion and 0 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 3 May 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?
patient satisfaction (time frame: Through study completion, an average of 1 month). 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 3 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.