Dental Caries in ChildrenPhase 4NCT05623605
Evaluation of New Different Herbal Mouthwashes Against Caries Forming Bacteria, RCT
A Phase 4 study testing Moringa mouthwash, star anise mouthwash and Indian costus mouth wash in people with Dental Caries in Children, run by Nahda University at 1 site in Egypt.
Trial summary
The goal of this randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Moringa mouthwash, star anise mouthwash and Indian costus mouth wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jun 2022to 30 Dec 2022
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- - Children with no systemic disease, no history of recent antibiotic administration (last 2 weeks), antimicrobial mouth-rinse (last 12 hours), topical fluoride treatment within 4 weeks prior to baseline, children with no untreated active carious lesion, no orthodontic appliance or with low caries index (DMF\& def < 4)
Who cannot join
- Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment
Trial locations and contacts
1 site in 1 country.
Mohamed Rashed, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
Ghada Salem
Maadi, Cairo Governorate, 11728
Ghada Salem, Ph.D, +201005144561, ghadamohamedalirana@hotmail.com
About this study
Official title: Evaluation of Antibacterial Potency of New Different Herbal Mouthwashes Against Caries Forming Bacteria, a Randomized Control Trial
The goal of this randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of the mouthwash 5,10,15%. the children were asked to rinse with the mouthwash 3 times per day for 1 week. bacterial count for streptococcus mutans was measured before and after the use of mouthwash to see the most effective concentration.
Read the detailed description
The powdered of Moringa, Star anis, and Indian Costus leaves (250 g) were extracted using 90% ethanol then filtered using Whatman Filter paper No.1 and dried under reduced pressure using rota vapor. The crude ethanolic extract was (200 mg). ninety children will be randomly distributed into three groups (1,2,3) (30 children each). each group was divided into further 3 groups (10 children each) according to the concentration of each herbal mouthwash (5,10,15%). each participant will be given a new bottle of a specific effective amount of herbal extract to be used as a mouthwash. Children will be instructed to rinse with 5ml of mouthwash. All groups were instructed to rinse three times a day with specific mouthwash for each group for about one minute and participants will be advised to use the mouthwash for seven days. Collection of saliva samples Prior to the start of the experiment, samples of unstimulated saliva were taken when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast. Initial salivary samples were collected to establish base levels (S1) using selective culture media, The salivary samples (S2) were collected after one week of using the mouthwash when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast.
- Conditions
- Dental Caries in Children
- Being tested
- Moringa mouthwash, star anise mouthwash, Indian costus mouth wash
- Keywords
- Moringa, Star Anis, Indian Costus, Mouth wash, Streptococus Mutans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa mouthwashDrug
Also called Moringa herbal mouthwash
using Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days
star anise mouthwashDrug
Also called star anise herbal mouthwash
using star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days
Indian costus mouth washDrug
Also called Indian costus herbal mouth wash
using Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Moringa mouthwash | Experimental | 5 ml Moringa mouthwash two times per day for 1 week Receives: Drug: Moringa mouthwash |
| Star Anis mouthwash | Experimental | 5 ml Star Anis mouthwash two times per day for 1 week Receives: Drug: star anise mouthwash |
| Indian Costus mouthwash | Experimental | 5 ml Indian Costus mouthwash two times per day for 1 week Receives: Drug: Indian costus mouth wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count
decrease the count of streptococus mutans after use of the herbal mouthwash
Measured: 1 weak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start19 Jun 2022
- Primary completion13 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nahda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GHada Abdelwahab Ahmed, Nahda University
- Investigators
- Mariem Elmansy, Ph.D, Study chair, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623605
- Sponsor's protocol ID
- 040522
- Status last verified
- Dec 2022
- First submitted
- 12 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibacterial Potency of New Different Herbal Mouthwashes Against Caries Forming Bacteria, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05623605
- Acronym / sponsor ID
- 040522
- Conditions
- Dental Caries in Children
- Keywords
- Moringa, Star Anis, Indian Costus, Mouth wash, Streptococus Mutans
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nahda UniversityUniversity, hospital or other
- Study start
- 19 Jun 2022 (actual)
- Primary completion
- 13 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Nov 2022 (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 randomized controlled trial is to compare three different types of mouthwash, Moringa, Star anis, and Indian Costus 90 children participated in this study divided into 3 groups according to the type of mouthwash used and then subdivided in each group into 3 subgroups according to the concentration of the mouthwash 5,10,15%. the children were asked to rinse with the mouthwash 3 times per day for 1 week. bacterial count for streptococcus mutans was measured before and after the use of mouthwash to see the most effective concentration.
Detailed description
The powdered of Moringa, Star anis, and Indian Costus leaves (250 g) were extracted using 90% ethanol then filtered using Whatman Filter paper No.1 and dried under reduced pressure using rota vapor. The crude ethanolic extract was (200 mg). ninety children will be randomly distributed into three groups (1,2,3) (30 children each). each group was divided into further 3 groups (10 children each) according to the concentration of each herbal mouthwash (5,10,15%). each participant will be given a new bottle of a specific effective amount of herbal extract to be used as a mouthwash. Children will be instructed to rinse with 5ml of mouthwash. All groups were instructed to rinse three times a day with specific mouthwash for each group for about one minute and participants will be advised to use the mouthwash for seven days. Collection of saliva samples Prior to the start of the experiment, samples of unstimulated saliva were taken when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast. Initial salivary samples were collected to establish base levels (S1) using selective culture media, The salivary samples (S2) were collected after one week of using the mouthwash when the child spit a suitable amount of unstimulated saliva in a sterile container in the morning before breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Moringa mouthwash | Experimental | Drug: Moringa mouthwash5 ml Moringa mouthwash two times per day for 1 week |
| Star Anis mouthwash | Experimental | Drug: star anise mouthwash5 ml Star Anis mouthwash two times per day for 1 week |
| Indian Costus mouthwash | Experimental | Drug: Indian costus mouth wash5 ml Indian Costus mouthwash two times per day for 1 week |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- - Children with no systemic disease, no history of recent antibiotic administration (last 2 weeks), antimicrobial mouth-rinse (last 12 hours), topical fluoride treatment within 4 weeks prior to baseline, children with no untreated active carious lesion, no orthodontic appliance or with low caries index (DMF\& def < 4)
Key exclusion criteria (1 listed)
- Children using antibiotics, medications or mouthwashes at the time of the study, children with oral or systemic disease, children undergoing any dental treatment
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 |
|---|---|---|
| Moringa mouthwashAlso: Moringa herbal mouthwashusing Moringa mouthwashes in 3 different concentrations (5,10,15%) twice per day for 7 days | Drug | Moringa mouthwash |
| star anise mouthwashAlso: star anise herbal mouthwashusing star anise mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days | Drug | Star Anis mouthwash |
| Indian costus mouth washAlso: Indian costus herbal mouth washusing Indian costus mouthwash in 3 different concentrations (5,10,15%) twice per day for 7 days | Drug | Indian Costus mouthwash |
Primary outcome
bacterial count
Time frame: 1 weak
decrease the count of streptococus mutans after use of the herbal mouthwash
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- 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.
Mohamed Rashed, Ph.D contact
Mariem Elmansy, Ph.D study chair
researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moringa mouthwash, star anise mouthwash and Indian costus mouth wash in people with Dental Caries in Children, run by Nahda University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada Salem, Ass. Professor (+201005144561, ghada.abdelwahab@nub.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial count (time frame: 1 weak). 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 14 Dec 2022.