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. Author manuscript; available in PMC: 2014 Jan 1.
Published in final edited form as: J Prosthodont. 2012 Oct 25;22(1):13–22. doi: 10.1111/j.1532-849X.2012.00906.x

Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
  1. At least 45 years of age

  2. Men or women without menses for 12 consecutive months or who have had a complete hysterectomy

  3. Wear complete maxillary denture (overdentures, implant- or tooth-retained dentures acceptable) without daily use of denture adhesive.

  4. Must have read, understood, and signed an informed consent form.

  5. Must understand and be willing to comply with all study procedures and restrictions

  6. Must be in good general health; diabetics included

  7. Must have type II or type III denture stomatitis for denture stomatitis group

  8. Must have no signs of denture stomatitis for control group

  1. Less than 45 years of age.

  2. Have chronic disease with oral manifestations other than denture/mucosal stomatitis.

  3. Have gross oral pathology.

  4. Have overt denture abrasion associated with symptoms.

  5. Participants with clinically significant organic diseases, including impaired renal function, bleeding disorder, or any condition requiring antibiotic pre-medication for dental visits

  6. Participants with active infectious diseases such as hepatitis, HIV, or tuberculosis.

  7. Participants who are immunosuppressed because of medications or condition.

  8. Participants who have used antibiotics or antifungals for any medical or dental condition within 1 month prior to screening.

  9. Participants using ongoing medications initiated less than 3 months prior to enrollment.

  10. Participants with a known or suspected intolerance to local oral anesthesia.

  11. Participants who have participated in another clinical study or have taken an investigational drug within 30 days of screening.

  12. Participants who have used tobacco products within 6 months of screening.

  13. Employees of the sponsor or the investigator or members of their immediate family.

  14. Participants who have previously participated in this study.

  15. Post-menopausal women on hormone replacement therapy.