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

Periodontitis Clinical Trial

— GNPG  

Official title:

Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816512
• Other study ID #: Antimicrobial Mouthwash
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2023
• Source: University of Baghdad
• Contact: Ahmed Yousif
• Phone: 009647703574622
• Email: ahmedyousifmahdi90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 20, 2024
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Gingivitis
• Periodontitis

Intervention

Drug:
• 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 .
• 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 .

Locations

Country	Name	City	State
Iraq	the specialist dental center in Diyala city	Baghdad

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Yousif Mahdi	University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks after mouth wash application