Denture StomatitisPhase 1NCT01643876
The Effect of Palatal Brushing on Denture Stomatitis
A Phase 1 study testing Palatal brushing in people with Denture Stomatitis, run by Université de Montréal at 2 sites in 2 countries.
Trial summary
Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers. However, there is no previous clinical trial testing this effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Palatal brushing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Mar 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Good general health.
- Completely edentulous maxilla.
- Currently wearing complete upper dentures.
- A clinical diagnosis of denture stomatitis.
Who cannot join
- Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
- Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
- Previous palatal brushing habit.
- Changing of the existing prosthesis during the trial.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Brazil1 site
University of Sao Paulo - Ribeirão Preto Dental School
Ribeirão Preto, São Paulo
Canada1 site
Faculté de Médecine Dentaire, Université de Montréal
Montreal, Quebec
About this study
Official title: Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.
However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.
Read more
After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).
Tested Hypotheses:
- There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
- There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.
- Conditions
- Denture Stomatitis
- Being tested
- Palatal brushing
- Keywords
- Denture stomatitis, Denture Plaque, Oral Candidiasis, Oral Hygiene
- Medical subject headings
- Stomatitis, Denture, Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal brushingBehavioural
Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
| Study group | Role | What they receive |
|---|---|---|
| Palatal brushing | Experimental | Palatal brushing after each meal for 3 months. Receives: Behavioral: Palatal brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palatal Inflammation
Modified Newton classification 0: Healthy mucosa
1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation
- Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
- Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
- Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index
0: Normal tissue
- Mild inflammation
- Moderate inflammation
- Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)
Measured: 3 months
Secondary outcomes (1)
Candida Species Count
Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Denture StomatitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Elham Emami, Université de Montréal
- Investigators
- Elham Emami, DDS, PhD, Principal investigator, Université de MontréalRaphael F de Souza, DDS, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643876
- Sponsor's protocol ID
- FMD-UdeM-EE-2012a
- Status last verified
- Dec 2013
- First submitted
- 16 Jul 2012
- Last updated
- 22 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis
- ClinicalTrials.gov ID
- NCT01643876
- Acronym / sponsor ID
- FMD-UdeM-EE-2012a
- Conditions
- Denture Stomatitis
- Keywords
- Denture stomatitis, Denture Plaque, Oral Candidiasis, Oral Hygiene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 22 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.
However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.
After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).
Tested Hypotheses:
- There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
- There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palatal brushing | Experimental | Behavioral: Palatal brushingPalatal brushing after each meal for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good general health.
- Completely edentulous maxilla.
- Currently wearing complete upper dentures.
- A clinical diagnosis of denture stomatitis.
Key exclusion criteria (4 listed)
- Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
- Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
- Previous palatal brushing habit.
- Changing of the existing prosthesis during 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 |
|---|---|---|
| Palatal brushingParticipants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing. | Behavioural | Palatal brushing |
Primary outcome
Palatal Inflammation
Time frame: 3 months
Modified Newton classification 0: Healthy mucosa 1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation 1. Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue 2. Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue 3. Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index 0: Normal tissue 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)
1 secondary outcome
Candida Species Count
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Denture Stomatitis
Not yet recruiting
Development of a Sanitizing Tablet for Removable Partial Dentures
Denture Stomatitis
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.
Elham Emami, DDS, PhD principal investigator
Université de Montréal
Raphael F de Souza, DDS, PhD principal investigator
University of Sao Paulo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Palatal brushing in people with Denture Stomatitis, run by Université de Montréal at 2 sites in 2 countries.
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 4 inclusion and 4 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Palatal Inflammation (time frame: 3 months). 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 22 Jan 2014.