NCT05390099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 20, 2022

Last Update Submit

May 24, 2022

Conditions

Oral Disease

Outcome Measures

Primary Outcomes (1)

  • gingival index (Loe and Sillness, 1963)

    index

    6 weeks

Secondary Outcomes (1)

  • plaque index (Sillness and Loe, 1964)

    6 weeks

Study Arms (2)

moringa plant toothpaste

EXPERIMENTAL
Drug: Moringa oleifera leaf

Fluoride toothpaste

ACTIVE COMPARATOR
Drug: Moringa oleifera leaf

Interventions

Moringa oleifera leafDRUG

Moringa toothpaste

Fluoride toothpastemoringa plant toothpaste

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • marwa m elchaghaby, phd

    marwaaly2003@yahoo.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa A elchaghaby, phd

CONTACT

01006231612marwaaly2003@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

April 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 7, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)