NCT06070571

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

May 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

October 6, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 24, 2023

Last Update Submit

September 30, 2023

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • antibacterial and anti inflammatory activities

    scoring of erthymia and pain (no pain=0) and the other end (worst pain=10).

    two weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Bucco-adhesive films with Yarrow and Moringa extract nanoparticles

Drug: Yarrow and moringa mixture

control group

ACTIVE COMPARATOR

Cholorohexiden oral gargles

Drug: Yarrow and moringa mixture

Interventions

Yarrow and moringa mixtureDRUG

yarrow and moringa mixture nano particles loaded on buccal film

Intervention groupcontrol group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, Minya Governorate, 05673, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Achillea millefolium flower

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • soad ali, PhD

    faculty of pharmacy, Deraya university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

October 6, 2023

Study Start

May 20, 2022

Primary Completion

December 20, 2022

Study Completion

May 20, 2023

Last Updated

October 6, 2023

Record last verified: 2023-09

Locations

EG(1)