NCT05816512

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

March 31, 2023

Last Update Submit

April 15, 2023

Conditions

Dental CariesGingivitisPeriodontitis

Keywords

Dental caries Gold Nanoparticle Pelargonium Graveolens

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 .

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 .

Drug: Chlorhexidine gluconate mouthwash .

Interventions

Gold Nano particle from Pelargonium Graveolens MouthwashDRUG

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 .

Also known as: Gold Nano particle Pelargonium Graveolens
Gold Nano particle from Pelargonium Graveolens Mouthwash group
Chlorhexidine gluconate mouthwash .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 .

Also known as: Chlorhexidine gluconate
Chlorhexidine gluconate mouth wash group

Eligibility Criteria

Age7 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 ).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the specialist dental center in Diyala city

Baghdad, 10081, Iraq

RECRUITING

MeSH Terms

Conditions

Dental CariesGingivitisPeriodontitis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Ahmed Yousif

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Yousif

CONTACT

009647703574622ahmedyousifmahdi90@gmail.com

Aseel Haider

CONTACT

009647901810659dr.aseelhaider@codental.uobaghdad.edu.iq

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Single (participant)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 18, 2023

Study Start

April 1, 2023

Primary Completion

September 20, 2023

Study Completion

March 20, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

IR(1)