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Completed

NCT Number: NCT01643876

The Effect of Palatal Brushing on Denture Stomatitis

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.

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Key information

Conditions

Denture Stomatitis Bacterial Infections and Mycoses Candidiasis Candidiasis, Oral Infections Mouth Diseases Mycoses Stomatitis Stomatitis, Denture Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Sao Paulo - Ribeirão Preto Dental School, Ribeirão Preto, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Palatal Inflammation

    Time frame: 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

    • Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
    • Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
    • Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index

    0: Normal tissue

    • Mild inflammation
    • Moderate inflammation
    • Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)

Secondary outcomes

  1. Candida Species Count

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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