Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05390099
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.2
• Patients Per Site Per Month: 18.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disease	Drug: Moringa oleifera leaf	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: moringa plant toothpaste	Drug: Moringa oleifera leaf; Moringa toothpaste
Active Comparator: Fluoride toothpaste	Drug: Moringa oleifera leaf; Moringa toothpaste

Outcome Measures

Primary Outcome Measures

1. gingival index (Loe and Sillness, 1963) [6 weeks]

   index

Secondary Outcome Measures

1. plaque index (Sillness and Loe, 1964) [6 weeks]

   index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university	Giza		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: marwa m elchaghaby, phd, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: marwa aly fouad elchaghaby, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05390099
• Other Study ID Numbers: Moringa toothpaste
• First Posted: May 25, 2022
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gingivitis; Mouth Diseases

Study Results

No Results Posted as of May 26, 2022