Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group

September 30, 2023 updated by: Deraya University

Clinical Assessment of Antibacterial Anti-inflammatory Activities of Yarrow Moringa Herbal Combinations in Bucco Adhesive Films

A double-blind, prospective, randomized, intra-individual comparative, single-center clinical study was conducted. Participants were placed in parallel groups, and the study was performed in the Department of Operative Dentistry and Periodontology, Dental School and Hospital, Minia university to compare the antibacterial activity of yarrow Moringa herbal combinations nanoparticles in compared to Chlorhexidine as a potential treatment for gingivitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • المنيا
      • Minya, المنيا, Egypt, 05673
        • Soad A. Mohamad

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • a minimum of four natural uncrowned teeth in one quadrant present
  • good general health
  • can follow instructions

Exclusion Criteria:

  • were pregnant or breastfeeding
  • evidence of antibiotic use during the 4 weeks prior to the study
  • were allergic to personal care/consumer products or their ingredients

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Bucco-adhesive films with Yarrow and Moringa extract nanoparticles
Drug: Yarrow and moringa mixture
yarrow and moringa mixture nano particles loaded on buccal film
Active Comparator: control group
Cholorohexiden oral gargles
Drug: Yarrow and moringa mixture
yarrow and moringa mixture nano particles loaded on buccal film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antibacterial and anti inflammatory activities
Time Frame: two weeks
scoring of erthymia and pain (no pain=0) and the other end (worst pain=10).
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Investigators

  • Study Director: soad ali, PhD, faculty of pharmacy, Deraya university

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)

May 20, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

September 24, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/23

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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