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Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children (GNPG)

Primary Purpose

Dental Caries, Gingivitis, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Gold Nano particle from Pelargonium Graveolens Mouthwash
Chlorhexidine gluconate mouthwash .
Sponsored by
Ahmed Yousif Mahdi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries Gold Nanoparticle Pelargonium Graveolens

Eligibility Criteria

7 Years - 14 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria: The study sample will include a group if children aged (7-14) years, with mild to moderate crowding, attending the specialist dental center in Diyala city. Patients with mild to moderate gingivitis as a base line (for standardization). Healthy child without any oral ulceration or systemic medical condition. Cooperative child. Patient did not take any antibiotics or anti-fungal for at least 4 weeks prior to sampling procedure. Children are healthy without any systemic disease . From the same geographical area ( Diyala Governorate ). Exclusion Criteria: Children outside specified age. Children with systemic disease or on medication. Children on a daily fluoride or other therapeutic regimen were excluded from the study. Children 's parents who are smokers (passive smoking ) to reduce the confounding factors. No more than one child per family to be allowed into the study. Children who their parents refuse to participate in the study.

Sites / Locations

  • the specialist dental center in Diyala cityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gold Nano particle from Pelargonium Graveolens Mouthwash group

Chlorhexidine gluconate mouth wash group

Arm Description

Gold Nano particle from Pelargonium Graveolens Mouthwash will be applied as a mouthwash for three weeks and then follow up .

Chlorhexidine gluconate mouth wash will be applied as a mouthwash for three weeks and then follow up .

Outcomes

Primary Outcome Measures

The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
The measure will be done using international detection and assessment criteria for diagnosing mild to moderate gingivitis by naked eye and periodantal probe.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
April 15, 2023
Sponsor
Ahmed Yousif Mahdi
Collaborators
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05816512
Brief Title
Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children
Acronym
GNPG
Official Title
Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
March 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Yousif Mahdi
Collaborators
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is randomized controlled trial ... The null hypothesis of the present study is that there is no antibacterial efficacy of gold nanoparticles of pelargonium graveolens mouthwash against Streptococcus mutans and Candida Albicans . Meanwhile the alternative hypothesis of the present study is that gold nanoparticles of pelargonium graveolens mouthwash have antimicrobial activity against Streptococcus mutans and Candida Albicans .
Detailed Description
This is double blind study will be conducted among male patients with mild to moderate gingivitis . Those patients aged between (7-14 ) years old who attended the second specialized dental health center in Baquba city/ Diyala governorate/ Iraq. patients will be randomly assigned to one of two study groups the first group is Gold Nano particle from Pelargonium Graveolens Mouthwash , the second Chlorhexidine. by using 15ml of it for one minute two times daily for three weeks. In this study a clinical parameters as ( plaque index, gingival index and calculus index ) were assessed at the base line (before mouthwash use), and then assessed three times at one week interval after the base line assessment through the period of mouthwash use. On the other hand, microbiological aspect were assessed for those patients before and three weeks after the use of Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine . After three weeks the mean of plaque, gingival, and culculs indices are significantly reduced after the use of Biogenic Gold Nano particle from Pelargonium Graveolens Leaves Extract Mouthwash.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Gingivitis, Periodontitis
Keywords
Dental caries Gold Nanoparticle Pelargonium Graveolens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Single (participant)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gold Nano particle from Pelargonium Graveolens Mouthwash group
Arm Type
Experimental
Arm Description
Gold Nano particle from Pelargonium Graveolens Mouthwash will be applied as a mouthwash for three weeks and then follow up .
Arm Title
Chlorhexidine gluconate mouth wash group
Arm Type
Active Comparator
Arm Description
Chlorhexidine gluconate mouth wash will be applied as a mouthwash for three weeks and then follow up .
Intervention Type
Drug
Intervention Name(s)
Gold Nano particle from Pelargonium Graveolens Mouthwash
Other Intervention Name(s)
Gold Nano particle Pelargonium Graveolens
Intervention Description
Gold Nano particle from Pelargonium Graveolens Mouthwash will be applied by using 15ml of it for one minute, two times daily for three weeks and then follow up after three weeks the clinical parameters as ( plaque index, gingival index and calculus index ) and microbiological aspect will be assessed .
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate mouthwash .
Other Intervention Name(s)
Chlorhexidine gluconate
Intervention Description
Chlorhexidine gluconate mouthwash will be applied by using 15ml of it for one minute, two times daily for three weeks and then follow up after three weeks the clinical parameters as ( plaque index, gingival index and calculus index ) and microbiological aspect will be assessed .
Primary Outcome Measure Information:
Title
The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
Description
The measure will be done using international detection and assessment criteria for diagnosing mild to moderate gingivitis by naked eye and periodantal probe.
Time Frame
3 weeks after mouth wash application

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The study sample will include a group if children aged (7-14) years, with mild to moderate crowding, attending the specialist dental center in Diyala city. Patients with mild to moderate gingivitis as a base line (for standardization). Healthy child without any oral ulceration or systemic medical condition. Cooperative child. Patient did not take any antibiotics or anti-fungal for at least 4 weeks prior to sampling procedure. Children are healthy without any systemic disease . From the same geographical area ( Diyala Governorate ). Exclusion Criteria: Children outside specified age. Children with systemic disease or on medication. Children on a daily fluoride or other therapeutic regimen were excluded from the study. Children 's parents who are smokers (passive smoking ) to reduce the confounding factors. No more than one child per family to be allowed into the study. Children who their parents refuse to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Yousif
Phone
009647703574622
Email
ahmedyousifmahdi90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aseel Haider
Phone
009647901810659
Email
dr.aseelhaider@codental.uobaghdad.edu.iq
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Yousif
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
the specialist dental center in Diyala city
City
Baghdad
ZIP/Postal Code
10081
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Yousif Mahdi
Phone
009647703574622
Email
ahmedyousifmahdi90@gmail.com
First Name & Middle Initial & Last Name & Degree
Aseel Haidar Mohammad Jawad
Phone
009647901810659
Email
dr.aseelhaider@codental.uobaghdad.edu.iq

12. IPD Sharing Statement

Learn more about this trial

Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children

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