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

NCT ID: NCT05816512

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-20

Brief Summary

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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

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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.

Conditions

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Dental Caries Gingivitis Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Single (participant)

Study Groups

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Gold Nano particle from Pelargonium Graveolens Mouthwash group

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

Group Type EXPERIMENTAL

Gold Nano particle from Pelargonium Graveolens Mouthwash

Intervention Type DRUG

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 .

Chlorhexidine gluconate mouth wash group

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine gluconate mouthwash .

Intervention Type DRUG

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 .

Interventions

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Gold Nano particle from Pelargonium Graveolens Mouthwash

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

Chlorhexidine gluconate mouthwash .

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 .

Intervention Type DRUG

Other Intervention Names

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Gold Nano particle Pelargonium Graveolens Chlorhexidine gluconate

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role collaborator

Ahmed Yousif Mahdi

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Yousif Mahdi

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed Yousif

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

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the specialist dental center in Diyala city

Baghdad, , Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Ahmed Yousif

Role: CONTACT

009647703574622

Aseel Haider

Role: CONTACT

009647901810659

Facility Contacts

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Ahmed Yousif Mahdi

Role: primary

009647703574622

Aseel Haidar Mohammad Jawad

Role: backup

009647901810659

Other Identifiers

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Antimicrobial Mouthwash

Identifier Type: -

Identifier Source: org_study_id

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