The Effectiveness of Palatal Brushing on Denture Stomatitis

Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02686632

Enrollment

Registered

2016-02-19

Start date

2016-09-30

Completion date

2018-05-31

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denture Stomatitis

Keywords

Denture Stomatitis, Denture Erythematous Stomatitis, Prosthesis Stomatitis, Oral Candidiasis, Palatal inflammation

Brief summary

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.

Interventions

BEHAVIORALPalatal brushing

Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Candida species colony forming units	Baseline to 6 months	Palatal saliva (swab) and denture sonicate will be analysed for Candida species CFU count at baseline, 3 months and 6 months. The results will be presented as change in mean CFU count.

Secondary

Measure	Time frame	Description
Clinical Inflammation	Baseline to 6 months	Change in clinical inflammation will be examined and recorded in both groups at baseline, 3 months and 6 months and presented as change in mean inflammation scores.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026