Periodontitis. The participants are in good general health, but have at least 2 residual dental lesions after periodontal treatment (standard care). MedDRA version: 20.1 Level: LLT Classification code 10009102 Term: Chronic periodontitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Fluconazol "Krka"
Product Name: Fluconazol Krka
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUCONAZOLE
CAS Number: 86386-73-4
Other descriptive name: FLUCONAZOLE
Concentration
Sponsors
Aarhus University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To investigate the effect of systemic fluconazole as adjunctive to standard care (professional mechanical biofilm control) on Candida-associated refractory periodontitis lesions. Treatment success is defined as absence of periodontal probing depth = 5 mm and bleeding on probing at 3 months after treatment of sites presenting refractory periodontitis lesions at baseline.;Secondary Objective: 1) Maintain the stability of clinical attachment levels obtained at 3 months. Defined as absence of sites losing more than 1 mm of clinical attachment level in total after 12, 24 and 36 months after completion of the intervention. 2) To determine the susceptibility to fluconazole in the identified Candida isolates before treatment and after 3 months of the intervention. 3) To describe the occurrence of Candida and distribution of Candida species in refractory periodontitis lesions. 4) To reduce significantly the total number of Candida and/or proportions of Candida of the total cultivable microbiota after 3 months of the intervention, and maintain the achieved levels of Candida at the 12- and 24-month follow-up appointments. 5) To adapt a real-time PCR method validated for blood samples for the detection of Candida species in periodontitis lesions and compare PCR with standard cultivation. ;Primary end point(s): No sites with bleeding on probing (BOP) and probing depth (PD) = 5 mm at 3 months, in refractory periodontitis lesions identified at the initial clinical exam. ;Timepoint(s) of evaluation of this end point: 1) 3 months after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) No sites presenting loss of clinical attachment level = 1 mm at the 12-, 24- and 36-month follow-up appointments. 2) No change in susceptibility levels to fluconazole in Candida isolates from the initial clinical exam to 3 months after intervention. 3) No endpoint for secondary objective 3 because it is descriptive. 4) No endpoint for secondary objective 4 because there are not data available to present a realistic estimate. Elimination of Candida cannot be expected since it is a resident of the oral microbiota in up to 50% of the healthy population. 5) No endpoint for secondary objective 5 because it is a methodological evaluation. ;Timepoint(s) of evaluation of this end point: 1) 12-, 24-, and 36- months after the intervention 2) 3 months after the intervention 3) baseline 4) 3-, 12-, and 24- months after the intervention 5) baseline, 3-, 12-, and 24- months after the intervention | — |
Countries
Denmark
Contacts
Public ContactSection of Periodontology
Aarhus University
Outcome results
None listed