Benefits of systemically administered adjunctive azithromycin with non-surgical periodontal therapy in treating advanced gum disease.

Phase 3

Completed

• Conditions: Stage III and IV, grade C periodontitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000560190
• Lead Sponsor: School of Dentistry, University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-10
• Study Completion: 2022-08-15
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean change in overall periodontal inflamed surface area (PISA) scores in patients with stage III and IV, grade C periodontitis. PISA score is a composite score calculated using clinical attachment level, gingival recession and bleeding on probing measured using a periodontal probe.[Assessed at baseline and 12 months after treatment.]