Candidiasis, OralNCT03894839
Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species
A study testing glutaraldehyde disinfection and microwave application, Chlorhexidine gluconate disinfection and microwave application and Sodium hypochlorite disinfection and microwave application in people with Candidiasis, Oral, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- glutaraldehyde disinfection and microwave application, Chlorhexidine gluconate disinfection and microwave application and Sodium hypochlorite disinfection and microwave application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2017to 22 Jan 2019
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients without any teeth
- Patients who had indicated to doing denture
Who cannot join
- patients with hyposalivation
- patients who use the medication that affects salivation
- patients who have chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Candidiasis, Oral
- Being tested
- 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
- Keywords
- Prothesis stomatitis, disinfection methods
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutaraldehyde disinfection and microwave applicationOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Chlorhexidine gluconate disinfection and microwave applicationOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Sodium hypochlorite disinfection and microwave applicationOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
glutaraldehyde disinfection and ozone therapyOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Chlorhexidine gluconate disinfection and ozone therapyOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
Sodium hypochlorite disinfection and ozone therapyOther
Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Sodium hypochlorite disinfection and ozone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start26 Oct 2017
- Primary completion26 Oct 2018
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, OralStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Ünalan Değirmenci, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894839
- Sponsor's protocol ID
- 20.06.2017/01
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28584537Pires 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.
PubMed 28232977Aslanimehr 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.
PubMed 30233654
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Cleaning and Disinfection Procedures on the Involvement of Candida Species
- ClinicalTrials.gov ID
- NCT03894839
- Acronym / sponsor ID
- 20.06.2017/01
- Conditions
- Candidiasis, Oral
- Keywords
- Prothesis stomatitis, disinfection methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 29 Mar 2019 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| glutaraldehyde disinfection and microwave application | Active comparator | Other: 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 |
| Chlorhexidine gluconate disinfection and microwave application | Active comparator | Other: 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 |
| Sodium hypochlorite disinfection and microwave application | Active comparator | Other: 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 |
| glutaraldehyde disinfection and ozone therapy | Active comparator | Other: 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 |
| Chlorhexidine gluconate disinfection and ozone therapy | Active comparator | Other: 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 |
| Sodium hypochlorite disinfection and ozone therapy | Active comparator | Other: 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients without any teeth
- Patients who had indicated to doing denture
Key exclusion criteria (3 listed)
- patients with hyposalivation
- patients who use the medication that affects salivation
- patients who have chemotherapy or radiotherapy
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 |
|---|---|---|
| glutaraldehyde disinfection and microwave applicationCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | glutaraldehyde disinfection and microwave application |
| Chlorhexidine gluconate disinfection and microwave applicationCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | Chlorhexidine gluconate disinfection and microwave application |
| Sodium hypochlorite disinfection and microwave applicationCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | Sodium hypochlorite disinfection and microwave application |
| glutaraldehyde disinfection and ozone therapyCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | glutaraldehyde disinfection and ozone therapy |
| Chlorhexidine gluconate disinfection and ozone therapyCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | Chlorhexidine gluconate disinfection and ozone therapy |
| Sodium hypochlorite disinfection and ozone therapyCombination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists | Other | Sodium hypochlorite disinfection and ozone therapy |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Results publication: PubMed 28584537Mojarad 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 publication: PubMed 28232977Pires 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 publication: PubMed 30233654Aslanimehr 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glutaraldehyde disinfection and microwave application, Chlorhexidine gluconate disinfection and microwave application and Sodium hypochlorite disinfection and microwave application in people with Candidiasis, Oral, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 29 Mar 2019. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and the types of Candida species that isolated from denture base after daily used disinfections on at 1st week (time frame: 1 week). The study lists 4 primary outcomes in all. 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 NCT03894839, which also lists 3 linked publications.
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 29 Mar 2019.