Brief Summary

Individuals may experience tooth loss as a result of trauma, periodontal destruction, lack of adequate bone support and clinically dental mobility. The increase in these tooth loss results in a condition called complete toothlessness in patients, and as a result of this, dentists treat complete dentures. It is known that the microorganism retention in the existing restorations is faster and higher than the natural tissues, and this leads to faster plaque build-up and hence bad odor. Candida species are common in oral flora, because they are numerous in the mouth and they are opportunistic pathogenic fungi that can make superficial and deep infections. The most important pathogen species among these parasites is Candida albicans. Mouth moniliasis or acute pseudomembrane candidiasis in the oral cavity of the so-called canker is caused by C.albicans. Chronic hyperplastic candidiasis is a clinical entity that is clinically inseparable from leukoplakia and completely separate from thrush. The accumulation of microorganisms in prosthetic materials is very important for the protection of the health of oral tissues and it is desirable to use appropriate cleaning and disinfection materials to minimize this accumulation. It is known in the literature that ozone and microwave technologies are used as disinfection technique. In this study, the application of ozone and microwave technologies in addition to the cleaning agents used as standard treatment will be compared in vivo. No such research has been found.The aim of this study was to evaluate the effect of different cleaning and disinfection procedures on the involvement of Candida species in complete denture patients.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Oct 2017

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

October 26, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2018

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2019

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed

11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed

Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2019

Last Update Submit

March 26, 2019

Conditions

Candidiasis, Oral

Keywords

Prothesis stomatitis, disinfection methods

Outcome Measures

Primary Outcomes (4)

Numbers and the types of Candida species that isolated from denture base after daily used disinfections on at 1st week
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
1 week
Numbers and the types of Candida species that isolated from denture base after professionally used disinfection methods on at 1st week
Disinfection methods which were done by dentists must decreased the number of Candida species that eliminated from denture surfaces.
1 week
Numbers and the types of Candida species that isolated from denture base after daily used disinfections on at 1st month
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
1 month
Numbers and the types of Candida species that isolated from denture base after professionally used disinfection methods on at 1st month
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
1 month

Study Arms (6)

glutaraldehyde disinfection and microwave application

ACTIVE COMPARATOR

%2 glutaraldehyde, solution form,duration time 1 minute and 1 time in a day by patients and 3 minutes 650 watt microwave energy application by dentists at each control session

Other: glutaraldehyde disinfection and microwave application

Chlorhexidine gluconate disinfection and microwave application

ACTIVE COMPARATOR

%2 chlorhexidine gluconate, solution form, duration time 1 minute and 1 time in a day by patients and 3 minutes 650 watt microwave energy application by dentists at each control session

Other: Chlorhexidine gluconate disinfection and microwave application

Sodium hypochlorite disinfection and microwave application

ACTIVE COMPARATOR

%5 sodium hypochlorite, solution form,duration time 1 minute and 1 time in a day by patients and 3 minutes 650 watt microwave energy application by dentists at each control session

Other: Sodium hypochlorite disinfection and microwave application

glutaraldehyde disinfection and ozone therapy

ACTIVE COMPARATOR

%2 glutaraldehyde, solution form,duration time 1 minute and 1 time in a day by patients and 15 minutes ozone therapy at each control session by dentists

Other: glutaraldehyde disinfection and ozone therapy

Chlorhexidine gluconate disinfection and ozone therapy

ACTIVE COMPARATOR

%2 chlorhexidine gluconate, solution form, duration time 1 minute and 1 time in a day by patients and 15 minutes ozone therapy at each control session by dentists

Other: Chlorhexidine gluconate disinfection and ozone therapy

Sodium hypochlorite disinfection and ozone therapy

ACTIVE COMPARATOR

%5 sodium hypochlorite, solution form,duration time 1 minute and 1 time in a day by patients and 15 minutes ozone therapy at each control session by dentists

Other: Sodium hypochlorite disinfection and ozone therapy