Oral DiseaseNCT05390099
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
A study testing Moringa oleifera leaf in people with Oral Disease, run by Cairo University at 1 site in Egypt.
Trial summary
The present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Oral Disease
- What is being tested?
- Moringa oleifera leaf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 7 Jul 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of 12-14 years of age.
- Presence of gingivitis-calculus, and plaque (gingival index [GI]score ≥1/plaque index [PI] score ≥1).
- Children willing to participate.
- Children whose parents/caretakers gave informed consent.
Who cannot join
- Children having fixed or removable orthodontic appliances or removable prostheses.
- Children suffering from any systemic illness.
- Children who were already using mouthwashes.
- History of oral prophylaxis within 6 months.
- Children using any other oral hygiene aids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes Among a Group of Egyptian Children: A Randomized Clinical Trial
The present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children.
Read the detailed description
In the last few years, the use of plant extracts in alternative medicine has evolved widely. Various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .Moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .
- Conditions
- Oral Disease
- Being tested
- Moringa oleifera leaf
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera leafDrug
Moringa toothpaste
| Study group | Role | What they receive |
|---|---|---|
| moringa plant toothpaste | Experimental | Not described Receives: Drug: Moringa oleifera leaf |
| Fluoride toothpaste | Active comparator | Not described Receives: Drug: Moringa oleifera leaf |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival index (Loe and Sillness, 1963)
index
Measured: 6 weeks
Secondary outcomes (1)
plaque index (Sillness and Loe, 1964)
index
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Apr 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion7 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa aly fouad elchaghaby, Cairo University
- Investigators
- marwa m elchaghaby, phd, Principal investigator, marwaaly2003@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390099
- Sponsor's protocol ID
- Moringa toothpaste
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 26 May 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes Among a Group of Egyptian Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05390099
- Acronym / sponsor ID
- Moringa toothpaste
- Conditions
- Oral Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 7 Jul 2022 (estimated)
- First posted
- 25 May 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 present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children.
Detailed description
In the last few years, the use of plant extracts in alternative medicine has evolved widely. Various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .Moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moringa plant toothpaste | Experimental | Drug: Moringa oleifera leaf |
| Fluoride toothpaste | Active comparator | Drug: Moringa oleifera leaf |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children of 12-14 years of age.
- Presence of gingivitis-calculus, and plaque (gingival index [GI]score ≥1/plaque index [PI] score ≥1).
- Children willing to participate.
- Children whose parents/caretakers gave informed consent.
Key exclusion criteria (5 listed)
- Children having fixed or removable orthodontic appliances or removable prostheses.
- Children suffering from any systemic illness.
- Children who were already using mouthwashes.
- History of oral prophylaxis within 6 months.
- Children using any other oral hygiene aids.
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 oleifera leafMoringa toothpaste | Drug | Fluoride toothpaste, moringa plant toothpaste |
Primary outcome
gingival index (Loe and Sillness, 1963)
Time frame: 6 weeks
index
1 secondary outcome
plaque index (Sillness and Loe, 1964)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
marwa m elchaghaby, phd principal investigator
marwaaly2003@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa oleifera leaf in people with Oral Disease, run by Cairo 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 4 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: status not confirmed, as of the sponsor's last update on 26 May 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.
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 marwa A elchaghaby, phd (01006231612, marwaaly2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival index (Loe and Sillness, 1963) (time frame: 6 weeks). 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 26 May 2022.