search
Back to results

Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species

Primary Purpose

Candidiasis, Oral

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
glutaraldehyde disinfection and microwave application
Chlorhexidine gluconate disinfection and microwave application
Sodium hypochlorite disinfection and microwave application
glutaraldehyde disinfection and ozone therapy
Chlorhexidine gluconate disinfection and ozone therapy
Sodium hypochlorite disinfection and ozone therapy
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Candidiasis, Oral focused on measuring Prothesis stomatitis, disinfection methods

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients without any teeth
  • Patients who had indicated to doing denture

Exclusion Criteria:

  • patients with hyposalivation
  • patients who use the medication that affects salivation
  • patients who have chemotherapy or radiotherapy

Sites / Locations

  • Beyza Ünalan Değirmenci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

glutaraldehyde disinfection and microwave application

Chlorhexidine gluconate disinfection and microwave application

Sodium hypochlorite disinfection and microwave application

glutaraldehyde disinfection and ozone therapy

Chlorhexidine gluconate disinfection and ozone therapy

Sodium hypochlorite disinfection and ozone therapy

Arm Description

%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

%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

%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

%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

%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

%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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 18, 2019
Last Updated
March 26, 2019
Sponsor
Yuzuncu Yıl University
search

1. Study Identification

Unique Protocol Identification Number
NCT03894839
Brief Title
Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species
Official Title
Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
January 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study is planned to be performed on 72 patients between the ages of 18-70 who were diagnosed and followed up in the Department of Prosthodontics of the Faculty of Dentistry of Yuzuncu Yil University. Patients with complete disability and indication of total prosthesis are included in the case group. In addition, individuals with systemic disturbance of salivation, radiotherapy-chemotherapy patients who are known to be able to facilitate Candida growth will be excluded from our study. The complete prosthesis made of polymethylmethacrylate material will be delivered to the patients. Before delivery, the polished surfaces of the relevant prosthesis, its vertical size, whether the patient is suitable for use or not, and the delivery of the prostheses that have passed the relevant controls will be considered appropriate. Patients will be asked to come for follow-up at 1 week and 1 month after the delivery of full dentures. The patients will be delivered with one of the glutaraldehyde, sodium hypochlorite or chlorhexidine digluconate solutions as the cleaning solution determined by the researchers during the initial delivery of their prostheses. Patients will be asked to clean with this relevant solution twice a day, in accordance with the specified times. At the 1 st and 1 st month follow-up, the prosthesis will be taken for the determination of the Candida number and species and the following procedures will be applied. Delivered prostheses will be taken in a 250 ml beaker (containing 100 ml of distilled water). Then, with the help of a swab, it will be contacted to the inner surfaces and edges of the prosthesis to allow mixing into the distilled water in possible biofilm layers. Then, the prosthesis will be removed and the distilled water will be homogenized by mixing thoroughly with the help of a stirrer. Later Zhou et al. According to the method used; 1 ml of distilled water will be transferred to falcon tubes. Pre-cultural Falcon tubes will be kept on ice for up to 1 hour. Prior to culture, samples will be diluted with sterile distilled water (1: 1, 1:10, 1: 100). And be mixed well using a vortex mixer. Then take 0.5 ml of these diluted liquids to be planted in Sabouraud Dextrose Agar. After 48 hours of incubation (microscopic and macroscopic evaluation), the number of colony forming units (CFU) of distilled water will be counted using two researchers. Then, Candida lara will be identified by an API test which will include 19 carbohydrate assimilation tests and negative control. The same processes will be repeated after the disinfection process with ozone or microwave to compare the effectiveness of the disinfection process. Thus, the daily recommended by physicians for the daily cleaning process, the suppression of reproduction and reproduction of Candida species, and a new method proposed by physicians to be applied as a new method of ozone and microwave and how much efficiency of sterilization on the Candida number will be compared on the basis of the effects will be compared. Statistical analysis will be done and interpreted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral
Keywords
Prothesis stomatitis, disinfection methods

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glutaraldehyde disinfection and microwave application
Arm Type
Active Comparator
Arm Description
%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
Arm Title
Chlorhexidine gluconate disinfection and microwave application
Arm Type
Active Comparator
Arm Description
%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
Arm Title
Sodium hypochlorite disinfection and microwave application
Arm Type
Active Comparator
Arm Description
%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
Arm Title
glutaraldehyde disinfection and ozone therapy
Arm Type
Active Comparator
Arm Description
%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
Arm Title
Chlorhexidine gluconate disinfection and ozone therapy
Arm Type
Active Comparator
Arm Description
%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
Arm Title
Sodium hypochlorite disinfection and ozone therapy
Arm Type
Active Comparator
Arm Description
%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
Intervention Type
Other
Intervention Name(s)
glutaraldehyde disinfection and microwave application
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Intervention Type
Other
Intervention Name(s)
Chlorhexidine gluconate disinfection and microwave application
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Intervention Type
Other
Intervention Name(s)
Sodium hypochlorite disinfection and microwave application
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Intervention Type
Other
Intervention Name(s)
glutaraldehyde disinfection and ozone therapy
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Intervention Type
Other
Intervention Name(s)
Chlorhexidine gluconate disinfection and ozone therapy
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Intervention Type
Other
Intervention Name(s)
Sodium hypochlorite disinfection and ozone therapy
Intervention Description
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Primary Outcome Measure Information:
Title
Numbers and the types of Candida species that isolated from denture base after daily used disinfections on at 1st week
Description
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
Time Frame
1 week
Title
Numbers and the types of Candida species that isolated from denture base after professionally used disinfection methods on at 1st week
Description
Disinfection methods which were done by dentists must decreased the number of Candida species that eliminated from denture surfaces.
Time Frame
1 week
Title
Numbers and the types of Candida species that isolated from denture base after daily used disinfections on at 1st month
Description
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
Time Frame
1 month
Title
Numbers and the types of Candida species that isolated from denture base after professionally used disinfection methods on at 1st month
Description
Chemical disinfectants which were used by patients must decreased the number of Candida species that eliminated from denture surfaces.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients without any teeth Patients who had indicated to doing denture Exclusion Criteria: patients with hyposalivation patients who use the medication that affects salivation patients who have chemotherapy or radiotherapy
Facility Information:
Facility Name
Beyza Ünalan Değirmenci
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28584537
Citation
Mojarad N, Khalili Z, Aalaei S. A comparison of the efficacy of mechanical, chemical, and microwave radiation methods in disinfecting complete dentures. Dent Res J (Isfahan). 2017 Mar-Apr;14(2):131-136.
Results Reference
result
PubMed Identifier
28232977
Citation
Pires CW, Fraga S, Beck AC, Braun KO, Peres PE. Chemical Methods for Cleaning Conventional Dentures: What is the Best Antimicrobial Option? An In Vitro Study. Oral Health Prev Dent. 2017;15(1):73-77. doi: 10.3290/j.ohpd.a37716.
Results Reference
result
PubMed Identifier
30233654
Citation
Aslanimehr M, Mojarad N, Ranjbar S, Aalaei S. In vitro comparison of the effects of microwave irradiation and chemical and mechanical methods on the disinfection of complete dentures contaminated with Candida albicans. Dent Res J (Isfahan). 2018 Sep-Oct;15(5):340-346.
Results Reference
result

Learn more about this trial

Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species

We'll reach out to this number within 24 hrs