Clinical trial NCT05816512: Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children
Official title: Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Gingivitis
Periodontitis
Keywords: Dental caries Gold Nanoparticle Pelargonium Graveolens
Lead sponsor: University of Baghdad
Sponsor class: OTHER
Collaborators: name: University of Baghdad
First posted: 2023-04-18
Enrollment: 60
Sex: MALE
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
timeFrame: 3 weeks after mouth wash application
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: the specialist dental center in Diyala city
Study officials:
affiliation: University of Baghdad
name: Ahmed Yousif
role: PRINCIPAL_INVESTIGATOR
References: