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

• ClinicalTrials.gov Identifier: NCT03894839
• Recruitment Status: Completed
• First Posted: March 29, 2019
• Last Update Posted: March 29, 2019
• Sponsor: Yuzuncu Yıl University
• Information provided by (Responsible Party): Beyza Ünalan Değirmenci, Yuzuncu Yıl University

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.

Condition or disease	Intervention/treatment	Phase
Candidiasis, Oral	Other: glutaraldehyde disinfection and microwave application; Other: Chlorhexidine gluconate disinfection and microwave application; Other: Sodium hypochlorite disinfection and microwave application; Other: glutaraldehyde disinfection and ozone therapy; Other: Chlorhexidine gluconate disinfection and ozone therapy; Other: Sodium hypochlorite disinfection and ozone therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species
• Actual Study Start Date: October 26, 2017
• Actual Primary Completion Date: October 26, 2018
• Actual Study Completion Date: January 22, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: glutaraldehyde disinfection and microwave application; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Active Comparator: Chlorhexidine gluconate disinfection and microwave application; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Active Comparator: Sodium hypochlorite disinfection and microwave application; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Active Comparator: glutaraldehyde disinfection and ozone therapy; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Active Comparator: Chlorhexidine gluconate disinfection and ozone therapy; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Active Comparator: Sodium hypochlorite disinfection and ozone therapy; %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; Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Beyza Ünalan Değirmenci

Van, Turkey, 65080

Sponsors and Collaborators

Yuzuncu Yıl University

More Information

Publications of Results:

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.

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.

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.

• Responsible Party: Beyza Ünalan Değirmenci, Assistant Professor, Yuzuncu Yıl University
• ClinicalTrials.gov Identifier: NCT03894839
• Other Study ID Numbers: 20.06.2017/01
• First Posted: March 29, 2019
• Last Update Posted: March 29, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beyza Ünalan Değirmenci, Yuzuncu Yıl University:

Prothesis stomatitis, disinfection methods

Additional relevant MeSH terms:

Candidiasis; Candidiasis, Oral; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases; Chlorhexidine; Chlorhexidine gluconate; Sodium Hypochlorite; Glutaral; Eusol; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents