None listed
Conditions
Brief summary
Few cases of periodontitis continue to have residual periodontal pockets with bleeding on probing despite well performed non-surgical periodontal therapy. It is unclear if the use of adjunctive systemic antimicrobials can provide clinical benefits in these cases. If the adjunctive systemic antimicrobial has additional anti-inflammatory properties it may help in the modulation of the host response. Azithromycin is one such antimicrobial with additional anti-inflammatory and host-modulating properties. Although the anti-microbial properties of azithromycin have been studied extensively, there are few studies on its host-modulating and anti-inflammatory properties in the treatment of periodontitis. It is hypothesized that adjunctive administration of azithromycin results in a gain in clinical attachment levels, decreased probing depths, decrease in Periodontal Inflammatory Surface Area (PISA) scores, decreased levels of pro-inflammatory cytokines and decrease in the number of pathogenic bacteria in the periodontal pockets among patients non-responsive to initial periodontal therapy.
Interventions
Systemic administration of azithromycin will be the intervention in the proposed clinical trial
the dose administered - 500mg
the duration of administration - once daily for 3 days
the mode of administration - oral capsules
Both the intervention and control groups will be treated with periodontal debridement at Brisbane City Periodontics and Implants, Brisbane, Mount Gravatt and Oral Health Centre, Herston by calibrated periodontists.
Test group will receive azithromycin 500 mg capsules along wi
Systemic administration of azithromycin will be the intervention in the proposed clinical trial the dose administered - 500mg the duration of administration - once daily for 3 days the mode of administration - oral capsules Both the intervention and control groups will be treated with periodontal debridement at Brisbane City Periodontics and Implants, Brisbane, Mount Gravatt and Oral Health Centre, Herston by calibrated periodontists. Test group will receive azithromycin 500 mg capsules along with periodontal debridement on first day (day 1). The remaining two capsules will be taken on the subsequent days (day 2 and 3). Control group will receive identical placebo capsules with periodontal debridement. Text message/phone call reminders will be placed to the study participants to monitor adherence to the intervention.
Sponsors
The 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
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
a) Diagnosis of periodontitis patients non-responsive to initial periodontal therapy will be determined by the presence of at least 4 sites with probing depth equal to or greater than 6 mm on at least two non-adjacent teeth with bleeding on probing at the recall visit after initial periodontal debridement. b) patients in the age range of 30 to 75 years c) Presence of 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 c) history of cardiac arrhythmias or history of myocardial infarction c) current smokers( equal to or greater than 10 cigarettes/day) d) Pregnant women e) patients with uncontrolled type II diabetes mellitus
Outcome results
None listed