StomatitisPhase 4NCT02407834
Effectiveness of Hygiene Solutions on Denture Biofilm
A Phase 4 study testing S1, S2 and S3 in people with Stomatitis, run by University of Sao Paulo.
Trial summary
This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomatitis
- What is being tested?
- S1, S2 and S3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 4
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.
Who cannot join
- Problems in adapting, reline, or repair fractures
- Patients with limited communication or collaboration as the following recommended protocol.
About this study
Official title: Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing
This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind and cross form with washout periods. 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. Patient satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of each maxillary complete denture was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two variation factors: inflammation and solutions. The candidiasis remission was analyzed after adjustment using multinomial logistic regression. Logistic regression analysis and compound symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α = 0.05).
Read the detailed description
Sixty-four denture wearers with (n=24) and without Candidiasis (n=40) were enrolled and instructed to brush and immerse their dentures in 4 different storage solutions (S1: 0.25% sodium hypochlorite; S2: 0.5% sodium hypochlorite; S3: 10% R. communis; and S4: Saline/Control). The interventions were randomly performed in a double blind and crossover format with washout periods. After 7 days of brushing and storage, the biofilm formed in the inner surfaces of dentures was disclosed and photographed to quantification. Candidiasis remission was assessed by scores and the patient satisfaction by a questionnaire. Antimicrobial activity of the solutions was determined by counting the Colony Forming Units (CFUs) of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, each complete upper denture was placed in a Petri dish, its internal surface was brushed (Tek brush) with saline solution for 2 min, and the biofilm suspension was transferred to a test tube. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated.
- Conditions
- Stomatitis
- Being tested
- S1, S2, S3, S4
- Keywords
- Biofilms, Dentures, Denture Cleansers, Castor Oil, Stomatitis
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S1Other
Also called 0.25% sodium hypochlorite
Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
S2Other
Also called 0.5% sodium hypochlorite
Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
S3Other
Also called 10% ricinus communis
Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
S4Other
Also called saline solution
Immersion in Saline solution for 20 minutes, during 7 days.
| Study group | Role | What they receive |
|---|---|---|
| S1 - 0.25% sodium hypochlorite | Experimental | Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days. Receives: Other: S1 |
| S2 - 0.5% sodium hypochlorite | Experimental | Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days. Receives: Other: S2 |
| S3 - 10% Ricinus communis | Experimental | Brushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days. Receives: Other: S3 |
| S4 - saline solution | Placebo comparator | Brushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days. Receives: Other: S4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
biofilm removal capacity using Image Tool software
Measured: 7 days
antimicrobial action against specific microorganisms by Colony Forming Units counts
Measured: 7 days
Secondary outcomes (2)
remission of atrophic chronic candidiasis using multinomial logistic regression analysis
Measured: 7 days
degree of patient satisfaction assessed by specific questionnaire
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Cláudia Helena Lovato da Silva, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407834
- Sponsor's protocol ID
- mestradopt2013
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing
- ClinicalTrials.gov ID
- NCT02407834
- Acronym / sponsor ID
- mestradopt2013
- Conditions
- Stomatitis
- Keywords
- Biofilms, Dentures, Denture Cleansers, Castor Oil, Stomatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Apr 2015 (estimated)
- 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 trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind and cross form with washout periods. 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. Patient satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of each maxillary complete denture was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two variation factors: inflammation and solutions. The candidiasis remission was analyzed after adjustment using multinomial logistic regression. Logistic regression analysis and compound symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α = 0.05).
Detailed description
Sixty-four denture wearers with (n=24) and without Candidiasis (n=40) were enrolled and instructed to brush and immerse their dentures in 4 different storage solutions (S1: 0.25% sodium hypochlorite; S2: 0.5% sodium hypochlorite; S3: 10% R. communis; and S4: Saline/Control). The interventions were randomly performed in a double blind and crossover format with washout periods. After 7 days of brushing and storage, the biofilm formed in the inner surfaces of dentures was disclosed and photographed to quantification. Candidiasis remission was assessed by scores and the patient satisfaction by a questionnaire. Antimicrobial activity of the solutions was determined by counting the Colony Forming Units (CFUs) of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, each complete upper denture was placed in a Petri dish, its internal surface was brushed (Tek brush) with saline solution for 2 min, and the biofilm suspension was transferred to a test tube. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S1 - 0.25% sodium hypochlorite | Experimental | Other: S1Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days. |
| S2 - 0.5% sodium hypochlorite | Experimental | Other: S2Brushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days. |
| S3 - 10% Ricinus communis | Experimental | Other: S3Brushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days. |
| S4 - saline solution | Placebo comparator | Other: S4Brushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.
Key exclusion criteria (2 listed)
- Problems in adapting, reline, or repair fractures
- Patients with limited communication or collaboration as the following recommended protocol.
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 |
|---|---|---|
| S1Also: 0.25% sodium hypochloriteImmersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days. | Other | S1 - 0.25% sodium hypochlorite |
| S2Also: 0.5% sodium hypochloriteImmersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days. | Other | S2 - 0.5% sodium hypochlorite |
| S3Also: 10% ricinus communisImmersion in 10% Ricinus communis for 20 minutes, during 7 days. | Other | S3 - 10% Ricinus communis |
| S4Also: saline solutionImmersion in Saline solution for 20 minutes, during 7 days. | Other | S4 - saline solution |
Primary outcome
biofilm removal capacity using Image Tool software
Time frame: 7 days
antimicrobial action against specific microorganisms by Colony Forming Units counts
Time frame: 7 days
2 secondary outcomes
remission of atrophic chronic candidiasis using multinomial logistic regression analysis
Time frame: 7 days
degree of patient satisfaction assessed by specific questionnaire
Time frame: 7 days
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 3 Apr 2015.
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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 Phase 4 study testing S1, S2 and S3 in people with Stomatitis, 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 1 inclusion and 2 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 3 Apr 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
biofilm removal capacity using Image Tool software (time frame: 7 days). The study lists 2 primary outcomes in all. 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 3 Apr 2015.