Adjunct effect of fluconazole in the treatment of Candida-associated refractory severe periodontitis – A single-center, placebo-controlled, triple blind, randomized clinical trial - Candida and periodontitis

Aarhus University0 个研究点目标入组 84 人开始时间: 2019年12月20日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•Volunteers aged 20-70 yr.
•At least 15 teeth
•At least two periodontitis lesions presenting with = 3 mm loss of clinical attachment level, = 5 mm of probing depth, and bleeding on probing
•Antibiotics prescribed from dentist within the last 12 months
•Fertile women: use of safe contraceptive measures (defined as intrauterine devices or hormonal contraception: oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•Presence of dental calculus that reveals poorly treated/untreated periodontitis;
•Need for antibiotic prophylaxis before mechanical biofilm control;
•Allergy to antimycotics;
•Use of medication precluding the use of fluconazole:
•1. Amiodaron
•2. Fluvastatin
•3. Pimozide
•4. Rifampicin (only if long duration of treatment)
•5. Erythromycin (only if long duration of treatment)
•Systemic conditions precluding the use of fluconazole:
•1. reduced adrenocortical function
•2. galactose intolerance
•3. complete lactase deficiency
•4. glucose/galactose malabsorption
•5. hypo serum potassium
•6. advanced heart failure
•7. proarythmic conditions
•Allergy to other components of fluconazol ”Krka”.
•Fertile women using safe contraceptive measures: current pregnancy (will be assessed with urine pregnancy test)
•Fertile women using safe contraceptive measures: current breastfeeding
•For menopausal women: Duration of menopause for less than 12 months

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