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

Sponsor
Ahmed Yousif Mahdi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05816512
Collaborator
University of Baghdad (Other)
60
1
2
11.6
5.2

Study Details

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: Gold Nano particle from Pelargonium Graveolens Mouthwash
  • Drug: Chlorhexidine gluconate mouthwash .
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Single (participant)
Primary Purpose:
Treatment
Official Title:
Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 20, 2023
Anticipated Study Completion Date :
Mar 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 .

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 .
Other Names:
  • Gold Nano particle Pelargonium Graveolens
  • Active Comparator: Chlorhexidine gluconate mouth wash group

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

    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 .
    Other Names:
  • Chlorhexidine gluconate
  • Outcome Measures

    Primary Outcome Measures

    1. The incidence of patient with mild to moderate gingivitis using international periodantal disease detection . [3 weeks after mouth wash application]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 14 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the specialist dental center in Diyala city Baghdad Iraq 10081

    Sponsors and Collaborators

    • Ahmed Yousif Mahdi
    • University of Baghdad

    Investigators

    • Principal Investigator: Ahmed Yousif, University of Baghdad

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Yousif Mahdi, Principal Investigator, University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT05816512
    Other Study ID Numbers:
    • Antimicrobial Mouthwash
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Yousif Mahdi, Principal Investigator, University of Baghdad
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2023