The Effectiveness of Palatal Brushing on Denture Stomatitis

U

Université de Montréal

Status

Completed

Conditions

Denture Stomatitis

Treatments

Behavioral: Palatal brushing

Study type

Interventional

Funder types

Other

Identifiers

NCT02686632
FMD-UdeM-EE-2016a

Details and patient eligibility

About

Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers. The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common. The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6 months.

Enrollment

52 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18 years or older
  • Wearing a maxillary and mandibular complete conventional denture
  • Having moderate to severe signs of denture stomatitis according to Schwartz index
  • Providing consent prior to study.

Exclusion criteria

  • Oral mucosal lesions other than denture stomatitis.
  • Systemic conditions which predispose to Candida specie infection such as uncontrolled diabetes and xerostomia.
  • History of chemotherapy/radiotherapy.
  • Used antibiotics, steroidal or antifungal agents in the 4 weeks prior to the study.
  • Scheduled to replace existing dentures with new ones during the length of the trial.
  • Already using palatal brushing as a routine oral hygiene procedure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 2 patient groups

Palate Brushing
Experimental group
Description:
In this group the intervention is "palatal brushing", performed by the participants following each meal for a period of 6 months. This will be performed using the provided toothbrush (device). The results will determine if brushing the palate in an efficient intervention for reducing the microbial count and inflammation associated with denture stomatitis.
Treatment:
Behavioral: Palatal brushing
Regular Oral Hygiene
No Intervention group
Description:
The participants in this study arm will not be prescribed or allocated any intervention. The participants will be asked to continue with the regular hygiene and denture maintenance practices for the duration of the trial.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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