Supplementary effect of antimycotics in the treatment of destructive gum disease – A placebo-controlled, blind, randomized clinical trial

Phase 1

• Conditions: Periodontitis.The participants are in good general health, but have at least 2 residual dental lesions after periodontal treatment (standard care).; MedDRA version: 20.1Level: LLTClassification code 10009102Term: Chronic periodontitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2019-003541-15-DK
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-20
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified