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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palatal brushing | Experimental | Palatal brushing after each meal for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palatal brushing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
0: Normal tissue
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elham Emami, DDS, PhD | Université de Montréal | Principal Investigator |
| Raphael F de Souza, DDS, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo - Ribeirão Preto Dental School | Ribeirão Preto | São Paulo | Brazil | |||
| Faculté de Médecine Dentaire, Université de Montréal |
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Recruitment from the prosthodontic clinics of the Université de Montréal and of Ribeirão Preto Dental School. Recruitment period dates: May 2012-February 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
0: Normal tissue
| Posted | Median | Full Range | units on a scale | 3 months |
|
3 months.
48 participants were assessed for adverse events. "0"Participants had any serious and/or non-serious adverse events after 3 months of assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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One group pre-test post-test study. External validity limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elham Emami | Université de Montréal | 5143436111 | 6053 | elham.emami@umontreal.ca |
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| ID | Term |
|---|---|
| D013282 | Stomatitis, Denture |
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002177 | Candidiasis |
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|
| Montreal |
| Quebec |
| Canada |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
|
| 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. | Posted | Median | Full Range | colony forming units (CFUs) | 3 months |
|
|
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| 0 |
| 48 |
| 0 |
| 48 |
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| D009181 |
| Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
|
| Colonies from palatal mucosa, post-intervention |
|