Back to resultsAnti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
Primary Purpose
Oral Disease
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Moringa oleifera leaf
Sponsored by
About this trial
This is an interventional treatment trial for Oral Disease
Eligibility Criteria
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.
Sites / Locations
- Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
moringa plant toothpaste
Fluoride toothpaste
Arm Description
Outcomes
Primary Outcome Measures
gingival index (Loe and Sillness, 1963)
index
Secondary Outcome Measures
plaque index (Sillness and Loe, 1964)
index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05390099
Brief Title
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 7, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
moringa plant toothpaste
Arm Type
Experimental
Arm Title
Fluoride toothpaste
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Moringa oleifera leaf
Intervention Description
Moringa toothpaste
Primary Outcome Measure Information:
Title
gingival index (Loe and Sillness, 1963)
Description
index
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
plaque index (Sillness and Loe, 1964)
Description
index
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
marwa A elchaghaby, phd
Phone
01006231612
Email
marwaaly2003@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa m elchaghaby, phd
Organizational Affiliation
marwaaly2003@yahoo.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes
We'll reach out to this number within 24 hrs