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

Sponsor

Deraya University (Other)

Overall Status

Completed

CT.gov ID

NCT06070571

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: Yarrow and moringa mixture	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2022

Actual Primary Completion Date :

Dec 20, 2022

Actual Study Completion Date :

May 20, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

antibacterial and anti inflammatory activities [two weeks]
scoring of erthymia and pain (no pain=0) and the other end (worst pain=10).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soad A. Mohamad	Minya	المنيا	Egypt	05673

Sponsors and Collaborators

Deraya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deraya University

ClinicalTrials.gov Identifier:

NCT06070571

Other Study ID Numbers:

3/23

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 6, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Study Results

No Results Posted as of Oct 6, 2023