Denture Stomatitis
Conditions
Keywords
Denture stomatitis, Denture Plaque, Oral Candidiasis, Oral Hygiene
Brief 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. 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.
Interventions
BEHAVIORALPalatal brushing
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.
Sponsors
University of Sao Paulo
Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Good general health. * Completely edentulous maxilla. * Currently wearing complete upper dentures. * A clinical diagnosis of denture stomatitis.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palatal Inflammation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Candida Species Count | 3 months | 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. |
Countries
Brazil, Canada
Participant flow
Recruitment details
Recruitment from the prosthodontic clinics of the Université de Montréal and of Ribeirão Preto Dental School. Recruitment period dates: May 2012-February 2013.
Participants by arm
| Arm | Count |
|---|---|
| Palatal Brushing Palatal brushing after each meal for 3 months.
Palatal brushing : 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. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Palatal Brushing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 66.0 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Brazil | 26 participants |
| Region of Enrollment Canada | 22 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
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 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)
Time frame: 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palatal Brushing | Palatal Inflammation | Modified Newton classification, pre-intervention | 3 units on a scale |
| Palatal Brushing | Palatal Inflammation | Modified Newton classification, post-intervention | 3 units on a scale |
| Palatal Brushing | Palatal Inflammation | Inflammation area index, pre-intervention | 2.5 units on a scale |
| Palatal Brushing | Palatal Inflammation | Inflammation area index, post-intervention | 2 units on a scale |
| Palatal Brushing | Palatal Inflammation | Inflammation severity index, pre-intervention | 2 units on a scale |
| Palatal Brushing | Palatal Inflammation | Inflammation severity index, post-intervention | 1 units on a scale |
| Palatal Brushing | Palatal Inflammation | Total score for inflammation, pre-intervention | 5 units on a scale |
| Palatal Brushing | Palatal Inflammation | Total score for inflammation, post-intervention | 3 units on a scale |
Comparison: Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palatal Brushing | Candida Species Count | Colonies from denture surface, pre-intervention | 1110 colony forming units (CFUs) |
| Palatal Brushing | Candida Species Count | Colonies from denture surface, post-intervention | 860 colony forming units (CFUs) |
| Palatal Brushing | Candida Species Count | Colonies from palatal mucosa, pre-intervention | 0 colony forming units (CFUs) |
| Palatal Brushing | Candida Species Count | Colonies from palatal mucosa, post-intervention | 0 colony forming units (CFUs) |
Comparison: Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.p-value: <0.05Wilcoxon (Mann-Whitney)