- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05390099
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
May 24, 2022 updated by: marwa aly fouad elchaghaby, Cairo University
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: marwa A elchaghaby, phd
- Phone Number: 01006231612
- Email: marwaaly2003@yahoo.com
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fluoride toothpaste
|
Moringa toothpaste
|
|
Experimental: moringa plant toothpaste
|
Moringa toothpaste
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gingival index (Loe and Sillness, 1963)
Time Frame: 6 weeks
|
index
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
plaque index (Sillness and Loe, 1964)
Time Frame: 6 weeks
|
index
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: marwa m elchaghaby, phd, marwaaly2003@yahoo.com
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 7, 2022
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Moringa toothpaste
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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