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The Effect of Palatal Brushing on Denture Stomatitis

U

Université de Montréal

Status and phase

Completed
Phase 1

Conditions

Denture Stomatitis

Treatments

Behavioral: Palatal brushing

Study type

Interventional

Funder types

Other

Identifiers

NCT01643876
FMD-UdeM-EE-2012a

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Palatal brushing
Experimental group
Description:
Palatal brushing after each meal for 3 months.
Treatment:
Behavioral: Palatal brushing

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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