CandidiasisNCT03203551
Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.
A study testing Disinfection Protocol in people with Candidiasis and Biofilms, run by University of Sao Paulo.
Trial summary
This clinical study identified the Candida species from the palate and complete dentures of edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of disinfectant solutions for denture hygiene on Candida spp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Biofilms, Candida Infection
- What is being tested?
- Disinfection Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- providing consent prior to participation in the study;
- being at least 18 years of age;
- maxillary complete conventional denture in good state and 1 year of use;
- dentures with biofilm in a internal surface;
- moderate to severe signs of Candidiasis.
Who cannot join
- presence oral mucosal lesions apart from Candidiasis;
- systemic or local conditions which predispose to Candida spp. infection;
- history of chemotherapy/ radiotherapy;
- having taken or used antibiotics, steroidal agents, or antifungal agents in the three months prior to the study;
- being scheduled to replace existing dentures with new ones during the period of the trial;
- dentures with adaptation or retention problems;
- already using palatal brushing or disinfectant solutions as a routine oral hygiene.
About this study
Official title: Clinical and Laboratorial Evaluation of the Effect of Sodium Hypochlorite, Chloramine T and Ricinus Communis Solutions in Candida Species Identified in the Biofilm of Total Prostheses and Palate of Total Edentulous Individuals.
This clinical study identified the Candida species from the palate and complete dentures of edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of disinfectant solutions for denture hygiene on Candida spp. Sixty participants were randomly assigned in 04 parallel groups (n = 15); They were oriented to brush their prostheses and the palate 3 times a day and immerse them in saline solution (C-control), 0.25% Sodium hypochlorite (HS0.25%), 10% Ricinus communis (RC10%) or 0.5% Chloramine T (CT 0.5%) for 20 minutes. Biofilm samples were collected from the prostheses and palate in the baseline, after 7 and 37 days of use of the solutions and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. To quantify biofilm with software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end of each period. The Candidiasis remission was assessed by scores before and after the use of solutions by palate's phographs. Descriptive analyzes were used for the identification and incidence of Candida spp. Kruskal-Wallis and Friedman tests, with stepwise step-down post-test for cell growth; ANOVA and Tukey for biofilm removal; Frequency of scores for evolution of inflammation. Level of significance was 95%. The most incident species were C. albicans, followed by C. tropicalis, C. glabrata and C. krusei. HS 0.25% reduced the incidence of the three species on the prostheses and palate in the periods of 7 and 37 days; CT 0.5% promoted reduction of Candida spp. only in dentures. R. communis decreased the incidence of C. tropicalis in both collection sites. For CFU counts, HS 0.25% and CT 0.5% caused significant reduction. For biofilm removal, HS0.25% was the most effective (9.75 ± 12.6) and RC10% (15.92 ± 14.8) intermediate. All groups decreased protheses-related stomatitis. HS0.25% has potential for clinical use as total denture disinfectants. RC10% and CT0.5% require further studies to be indicated as alternative solutions.
- Conditions
- Candidiasis, Biofilms, Candida Infection
- Being tested
- Disinfection Protocol
- Keywords
- Dentures, Biofilms, Disinfection, Candidiasis, Candida
- Medical subject headings
- Candidiasis, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disinfection ProtocolOther
Also called Denture Hygiene Protocol
The participants assigned to this group carried out the disinfection protocol that recommended brushing the palate (3 times a day), brushing the total prosthesis with neutral liquid soap (3 times a day) and immersing in different desinfection solutions (once a day/ 20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| C; Control; Saline solution | Placebo comparator | Disinfection protocol:
* brushing the palate (3 times a day/ 2 minutes);
* brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes);
* immersing the total prostheses in Saline solution (once a day/ 20 minutes) before the last brushing of the day;
* the prostheses must be conditioned in a vessel with water during the whole night period.
Periods of analysis (Baseline, 7 and 37 days):
* the prostheses will be evidenced and photographed.
* the biofilm present on the inner surface of the prostheses will be collected;
* photographe of the participants' palate;
* collected the palate biofilm. Receives: Other: Disinfection Protocol |
| HS0.25%; 0.25% Sodium Hypochlorite | Experimental | Disinfection protocol:
* brushing the palate (3 times a day/ 2 minutes);
* brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes);
* immersing the total prostheses in 0.25% Sodium Hypochlorite (once a day/ 20 minutes) before the last brushing of the day;
* the prostheses must be conditioned in a vessel with water during the whole night period.
Periods of analysis (Baseline, 7 and 37 days):
* the prostheses will be evidenced and photographed.
* the biofilm present on the inner surface of the prostheses will be collected;
* photographe of the participants' palate;
* collected the palate biofilm. Receives: Other: Disinfection Protocol |
| RC10%; 10% Ricinus communis | Experimental | Disinfection protocol:
* brushing the palate (3 times a day/ 2 minutes);
* brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes);
* immersing the total prostheses in 10% Ricinus communis (once a day/ 20 minutes) before the last brushing of the day;
* the prostheses must be conditioned in a vessel with water during the whole night period.
Periods of analysis (Baseline, 7 and 37 days):
* the prostheses will be evidenced and photographed.
* the biofilm present on the inner surface of the prostheses will be collected;
* photographe of the participants' palate;
* collected the palate biofilm. Receives: Other: Disinfection Protocol |
| CT0.5%; 0.5% Chloramine T | Experimental | Disinfection protocol:
* brushing the palate (3 times a day/ 2 minutes);
* brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes);
* immersing the total prostheses in 0.5% Choramine T (once a day/ 20 minutes) before the last brushing of the day;
* the prostheses must be conditioned in a vessel with water during the whole night period.
Periods of analysis (Baseline, 7 and 37 days):
* the prostheses will be evidenced and photographed.
* the biofilm present on the inner surface of the prostheses will be collected;
* photographe of the participants' palate;
* collected the palate biofilm. Receives: Other: Disinfection Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Biofilm samples were collected from the prosthesis and palate in the baseline and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. The inner surface of the denture was disclosed (1% neutral red) and photographed at the end to quantify the biofilm with the software ImageTool 3.0. The palate with Candidiasis was photographed and assessed by scores.
Measured: Baseline (without disinfection procedures)
Secondary outcomes (2)
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 7 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Biofilm samples were collected from the prostheses and palate after 7 days of use of the solutions and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. To quantify the denture biofilm with software ImageTool 3.0, the inner surface of the denture was disclosed (1% neutral red) and photographed at the end of 7 days. The Candidiasis remission was photographed and assessed by scores after 7 days of use solutions.
Measured: 7 days of disinfection
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 37 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Biofilm samples were collected from the prostheses and palate after 37 days of use of the solutions and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. To quantify the denture biofilm with software ImageTool 3.0, the inner surface of the denture was disclosed (1% neutral red) and photographed at the end of 37 days. The Candidiasis remission was photographed and assessed by scores after 37 days of use solutions.
Measured: 37 days of disinfection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Sep 2014
- Primary completion1 Jan 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Helena Lovato da Silva, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203551
- Sponsor's protocol ID
- FORP/USP
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratorial Evaluation of the Effect of Sodium Hypochlorite, Chloramine T and Ricinus Communis Solutions in Candida Species Identified in the Biofilm of Total Prostheses and Palate of Total Edentulous Individuals.
- ClinicalTrials.gov ID
- NCT03203551
- Acronym / sponsor ID
- FORP/USP
- Conditions
- Candidiasis, Biofilms, Candida Infection
- Keywords
- Dentures, Biofilms, Disinfection, Candidiasis, Candida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 29 Jun 2017 (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.
This clinical study identified the Candida species from the palate and complete dentures of edentulous individuals with prostheses-related stomatitis (PRS) and evaluated the effect of disinfectant solutions for denture hygiene on Candida spp. Sixty participants were randomly assigned in 04 parallel groups (n = 15); They were oriented to brush their prostheses and the palate 3 times a day and immerse them in saline solution (C-control), 0.25% Sodium hypochlorite (HS0.25%), 10% Ricinus communis (RC10%) or 0.5% Chloramine T (CT 0.5%) for 20 minutes. Biofilm samples were collected from the prostheses and palate in the baseline, after 7 and 37 days of use of the solutions and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. To quantify biofilm with software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end of each period. The Candidiasis remission was assessed by scores before and after the use of solutions by palate's phographs. Descriptive analyzes were used for the identification and incidence of Candida spp. Kruskal-Wallis and Friedman tests, with stepwise step-down post-test for cell growth; ANOVA and Tukey for biofilm removal; Frequency of scores for evolution of inflammation. Level of significance was 95%. The most incident species were C. albicans, followed by C. tropicalis, C. glabrata and C. krusei. HS 0.25% reduced the incidence of the three species on the prostheses and palate in the periods of 7 and 37 days; CT 0.5% promoted reduction of Candida spp. only in dentures. R. communis decreased the incidence of C. tropicalis in both collection sites. For CFU counts, HS 0.25% and CT 0.5% caused significant reduction. For biofilm removal, HS0.25% was the most effective (9.75 ± 12.6) and RC10% (15.92 ± 14.8) intermediate. All groups decreased protheses-related stomatitis. HS0.25% has potential for clinical use as total denture disinfectants. RC10% and CT0.5% require further studies to be indicated as alternative solutions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C; Control; Saline solution | Placebo comparator | Other: Disinfection ProtocolDisinfection protocol: * brushing the palate (3 times a day/ 2 minutes); * brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes); * immersing the total prostheses in Saline solution (once a day/ 20 minutes) before the last brushing of the day; * the prostheses must be conditioned in a vessel with water during the whole night period. Periods of analysis (Baseline, 7 and 37 days): * the prostheses will be evidenced and photographed. * the biofilm present on the inner surface of the prostheses will be collected; * photographe of the participants' palate; * collected the palate biofilm. |
| HS0.25%; 0.25% Sodium Hypochlorite | Experimental | Other: Disinfection ProtocolDisinfection protocol: * brushing the palate (3 times a day/ 2 minutes); * brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes); * immersing the total prostheses in 0.25% Sodium Hypochlorite (once a day/ 20 minutes) before the last brushing of the day; * the prostheses must be conditioned in a vessel with water during the whole night period. Periods of analysis (Baseline, 7 and 37 days): * the prostheses will be evidenced and photographed. * the biofilm present on the inner surface of the prostheses will be collected; * photographe of the participants' palate; * collected the palate biofilm. |
| RC10%; 10% Ricinus communis | Experimental | Other: Disinfection ProtocolDisinfection protocol: * brushing the palate (3 times a day/ 2 minutes); * brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes); * immersing the total prostheses in 10% Ricinus communis (once a day/ 20 minutes) before the last brushing of the day; * the prostheses must be conditioned in a vessel with water during the whole night period. Periods of analysis (Baseline, 7 and 37 days): * the prostheses will be evidenced and photographed. * the biofilm present on the inner surface of the prostheses will be collected; * photographe of the participants' palate; * collected the palate biofilm. |
| CT0.5%; 0.5% Chloramine T | Experimental | Other: Disinfection ProtocolDisinfection protocol: * brushing the palate (3 times a day/ 2 minutes); * brushing the total prostheses with neutral liquid soap (3 times a day/ 3 minutes); * immersing the total prostheses in 0.5% Choramine T (once a day/ 20 minutes) before the last brushing of the day; * the prostheses must be conditioned in a vessel with water during the whole night period. Periods of analysis (Baseline, 7 and 37 days): * the prostheses will be evidenced and photographed. * the biofilm present on the inner surface of the prostheses will be collected; * photographe of the participants' palate; * collected the palate biofilm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- providing consent prior to participation in the study;
- being at least 18 years of age;
- maxillary complete conventional denture in good state and 1 year of use;
- dentures with biofilm in a internal surface;
- moderate to severe signs of Candidiasis.
Key exclusion criteria (7 listed)
- presence oral mucosal lesions apart from Candidiasis;
- systemic or local conditions which predispose to Candida spp. infection;
- history of chemotherapy/ radiotherapy;
- having taken or used antibiotics, steroidal agents, or antifungal agents in the three months prior to the study;
- being scheduled to replace existing dentures with new ones during the period of the trial;
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 |
|---|---|---|
| Disinfection ProtocolAlso: Denture Hygiene ProtocolThe participants assigned to this group carried out the disinfection protocol that recommended brushing the palate (3 times a day), brushing the total prosthesis with neutral liquid soap (3 times a day) and immersing in different desinfection solutions (once a day/ 20 minutes) | Other | C; Control; Saline solution, CT0.5%; 0.5% Chloramine T, HS0.25%; 0.25% Sodium Hypochlorite, RC10%; 10% Ricinus communis |
Primary outcome
Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Time frame: Baseline (without disinfection procedures)
Biofilm samples were collected from the prosthesis and palate in the baseline and seeded in CHROMagar Candida medium. After incubation period, the presumptive identification, incidence verification and quantification of Candida species growth (CFU count) were performed. The inner surface of the denture was disclosed (1% neutral red) and photographed at the end to quantify the biofilm with the software ImageTool 3.0. The palate with Candidiasis was photographed and assessed by scores.
2 secondary outcomes
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 7 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Time frame: 7 days of disinfection
Clinical evaluation of the effect of Sodium hypochlorite, Chloramine T and Ricinus communis solutions after 37 days of use in Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals.
Time frame: 37 days of disinfection
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 2 Jul 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Disinfection Protocol in people with Candidiasis and Biofilms, run by University of Sao Paulo.
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 5 inclusion and 7 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Clinical evaluation of the Candida species identified in the biofilm of total prostheses and palate of total edentulous individuals. (time frame: Baseline (without disinfection procedures)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.