Dental CariesGNPGNCT05816512
Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children
A study testing Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine gluconate mouthwash . in people with Dental Caries and Gingivitis, run by Ahmed Yousif Mahdi at 1 site in Iraq.
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 . Read more about this study
- Who is it for?
- Ages 7 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingivitis, Periodontitis
- What is being tested?
- Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine gluconate mouthwash .
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2023to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 ).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
the specialist dental center in Diyala city
Baghdad, 10081
Ahmed Yousif Mahdi, 009647703574622, ahmedyousifmahdi90@gmail.com
Aseel Haidar Mohammad Jawad, 009647901810659, dr.aseelhaider@codental.uobaghdad.edu.iq
About this study
Official title: Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
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 .
Read the 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.
- Conditions
- Dental Caries, Gingivitis, Periodontitis
- Being tested
- Gold Nano particle from Pelargonium Graveolens Mouthwash, Chlorhexidine gluconate mouthwash .
- Keywords
- Dental caries Gold Nanoparticle Pelargonium Graveolens
- Medical subject headings
- Dental Caries, Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold Nano particle from Pelargonium Graveolens MouthwashDrug
Also called Gold Nano particle Pelargonium Graveolens
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 .Drug
Also called Chlorhexidine gluconate
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 .
| Study group | Role | What they receive |
|---|---|---|
| Gold Nano particle from Pelargonium Graveolens Mouthwash group | Experimental | Gold Nano particle from Pelargonium Graveolens Mouthwash will be applied as a mouthwash for three weeks and then follow up . Receives: Drug: Gold Nano particle from Pelargonium Graveolens Mouthwash |
| Chlorhexidine gluconate mouth wash group | Active comparator | Chlorhexidine gluconate mouth wash will be applied as a mouthwash for three weeks and then follow up . Receives: Drug: Chlorhexidine gluconate mouthwash . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks after mouth wash application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Yousif Mahdi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Baghdad
- Responsible party
- Sponsor-investigator, Ahmed Yousif Mahdi, University of Baghdad
- Investigators
- Ahmed Yousif, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816512
- Sponsor's protocol ID
- Antimicrobial Mouthwash
- Acronym
- GNPG
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Asker AYM, Al Haidar AHMJ. Antimicrobial Efficacy of Pelargonium Graveolens Gold Nanoparticles: A Novel Mouthwash for Children. Int J Dent Hyg. 2026 Apr 26. doi: 10.1111/idh.70071. Online ahead of print.
PubMed 42036760
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children. (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05816512
- Acronym / sponsor ID
- GNPG / Antimicrobial Mouthwash
- Conditions
- Dental Caries, Gingivitis, Periodontitis
- Keywords
- Dental caries Gold Nanoparticle Pelargonium Graveolens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed Yousif MahdiUniversity, hospital or other
- Collaborators
- University of Baghdad
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold Nano particle from Pelargonium Graveolens Mouthwash group | Experimental | Drug: Gold Nano particle from Pelargonium Graveolens MouthwashGold Nano particle from Pelargonium Graveolens Mouthwash will be applied as a mouthwash for three weeks and then follow up . |
| Chlorhexidine gluconate mouth wash group | Active comparator | Drug: Chlorhexidine gluconate mouthwash .Chlorhexidine gluconate mouth wash will be applied as a mouthwash for three weeks and then follow up . |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gold Nano particle from Pelargonium Graveolens MouthwashAlso: Gold Nano particle Pelargonium GraveolensGold 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 . | Drug | Gold Nano particle from Pelargonium Graveolens Mouthwash group |
| Chlorhexidine gluconate mouthwash .Also: Chlorhexidine gluconateChlorhexidine 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 . | Drug | Chlorhexidine gluconate mouth wash group |
Primary outcome
The incidence of patient with mild to moderate gingivitis using international periodantal disease detection .
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 42036760Asker AYM, Al Haidar AHMJ. Antimicrobial Efficacy of Pelargonium Graveolens Gold Nanoparticles: A Novel Mouthwash for Children. Int J Dent Hyg. 2026 Apr 26. doi: 10.1111/idh.70071. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Yousif principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine gluconate mouthwash . in people with Dental Caries and Gingivitis, run by Ahmed Yousif Mahdi at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Yousif (009647703574622, ahmedyousifmahdi90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of patient with mild to moderate gingivitis using international periodantal disease detection . (time frame: 3 weeks after mouth wash application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.