None listed
Conditions
Brief summary
Periodontitis, especially stage III and IV, grade C periodontitis carries significant chances of tooth loss. Adjunctive systemic antimicrobials may provide additional benefits in these patients, however, the evidence is unclear. If the adjunctive antimicrobial has additional anti-inflammatory properties it may help in the modulation of the host response. Azithromycin is one such antimicrobial with additional host-modulating properties. Although the anti-microbial properties of azithromycin have been studied extensively, there are few studies on its host-modulating properties in periodontitis. It is hypothesized that adjunctive administration of azithromycin will result in decreased periodontal inflamed surface area scores, gain in clinical attachment level, reduced pocket depth, decreased levels of pro-inflammatory cytokines in the gingival crevicular fluid & saliva and decrease in the number of pathogenic bacteria in the periodontal pockets.
Interventions
Systemic administration of azithromycin will be the intervention in the proposed clinical trial
Test group: Non-surgical periodontal therapy + systemic azithromycin
-the dose administered, 500mg
- the duration of administration, once daily for 3 days
- the mode of administration, oral capsules
Control group:
Non-surgical periodontal therapy plus placebo capsules
Both the test and control groups will be treated with non-surgical periodontal therapy(periodontal debridement) at the Oral Health Cent
Systemic administration of azithromycin will be the intervention in the proposed clinical trial Test group: Non-surgical periodontal therapy + systemic azithromycin -the dose administered, 500mg - the duration of administration, once daily for 3 days - the mode of administration, oral capsules Control group: Non-surgical periodontal therapy plus placebo capsules Both the test and control groups will be treated with non-surgical periodontal therapy(periodontal debridement) at the Oral Health Centre, Herston, Brisbane City Periodontics and Implants, Brisbane, Mount Gravatt and Specialist Dental Centre, Penrith by calibrated periodontists. Non-surgical periodontal therapy will be completed within three days. Test group will start azithromycin oral capsules on the first day of non-surgical periodontal therapy. Control group will receive placebo capsules on the first day of non-surgical periodontal therapy. Another two doses of azithromycin and placebo capsules will be taken on the next subsequent days (day 2 and day 3). Text message reminders/phone call reminders will be made to the participants to monitor adherence to the intervention.
Sponsors
School of Dentistry, University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
a) diagnosis of stage III and IV periodontitis, defined by at least 30% of the sites with probing depth or clinical attachment level (CAL) equal to or greater than 4 mm with bleeding on probing (BOP). Additionally the presence of pocket depth equal to or greater than 6 mm with bleeding on probing on at least 6 sites on a minimum of 3 teeth. Grade C periodontitis is further defined by presence of ONE of the following features: • equal to greater than 2 mm of CAL loss over 5 years, • % bone loss/age > 1.0, • destruction exceeds expectation given biofilm deposits, specific clinical patterns suggestive of periods of rapid progression and early onset disease (e.g., molar/incisor pattern), • smokers equal to greater than 10 cigarettes/day, • HbA1c equal to or greater than 7.0% in patients with diabetes mellitus b. age 25 to 75 years; c. At least 16 natural teeth.
Exclusion criteria
a. use of antimicrobials within 3 months preceding the start of the study; b. history of sensitivity to azithromycin or macrolides d. prolonged QT interval or history of cardiac arrhythmia or history of myocardial infarction e. periodontal debridement in the past 6 months f. pregnant women
Outcome results
None listed