Clinical Evaluation and Assesment of Ginigivitis Patients... | NCT06070571

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

NCT06070571

Sponsor

Deraya University

Status

Completed

Last Update Posted

Oct 6, 2023Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Gingivitis

Interventions

Yarrow and moringa mixture

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2022Actual

Primary Completion Date

Dec 20, 2022Actual

Completion Date

May 20, 2023Actual

First Submitted Date

Sep 24, 2023

First Submission Date that Met QC Criteria

Sep 30, 2023

First Posted Date

Oct 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2023

Last Update Posted Date

Oct 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Yarrow and moringa mixture	Drug	yarrow and moringa mixture nano particles loaded on buccal film	Intervention group control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
soad ali, PhD	faculty of pharmacy, Deraya university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soad A. Mohamad		Minya	Minya Governorate	05673	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005891	Gingivitis

Ancestor Terms

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713348	Achillea millefolium flower

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided