Back to resultsClinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group
Primary Purpose
Gingivitis
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Yarrow and moringa mixture
Sponsored by
About this trial
This is an interventional treatment trial for Gingivitis
Eligibility Criteria
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
Sites / Locations
- Soad A. Mohamad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
control group
Arm Description
Bucco-adhesive films with Yarrow and Moringa extract nanoparticles
Cholorohexiden oral gargles
Outcomes
Primary Outcome Measures
antibacterial and anti inflammatory activities
scoring of erthymia and pain (no pain=0) and the other end (worst pain=10).
Secondary Outcome Measures
Full Information
NCT ID
NCT06070571
First Posted
September 24, 2023
Last Updated
September 30, 2023
Sponsor
Deraya University
1. Study Identification
Unique Protocol Identification Number
NCT06070571
Brief Title
Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group
Official Title
Clinical Assessment of Antibacterial Anti-inflammatory Activities of Yarrow Moringa Herbal Combinations in Bucco Adhesive Films
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
May 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deraya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Bucco-adhesive films with Yarrow and Moringa extract nanoparticles
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Cholorohexiden oral gargles
Intervention Type
Drug
Intervention Name(s)
Yarrow and moringa mixture
Intervention Description
yarrow and moringa mixture nano particles loaded on buccal film
Primary Outcome Measure Information:
Title
antibacterial and anti inflammatory activities
Description
scoring of erthymia and pain (no pain=0) and the other end (worst pain=10).
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
soad ali, PhD
Organizational Affiliation
faculty of pharmacy, Deraya university
Official's Role
Study Director
Facility Information:
Facility Name
Soad A. Mohamad
City
Minya
State/Province
المنيا
ZIP/Postal Code
05673
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group
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