The clinical efficacy of non-surgical periodontal debridement alone, adjunctive systemic azithromycin, or amoxicillin-metronidazole therapy in patients with chronic moderate-to-advanced periodontitis

Comparing the periodontal tissue response to non-surgical scaling and root planing alone, adjunctive azithromycin, or adjunctive amoxicillin plus metronidazole in generalised chronic moderate-to-severe periodontitis: a preliminary randomised controlled trial.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000957291

Enrollment

Registered

2018-06-06

Start date

2016-07-06

Completion date

2017-05-17

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The administration of systemic antibiotic adjuncts following scaling and root planing to further expedite healing of the periodontal tissues is a topic of considerable interest, given the lack of evidence-based guidelines for their use in periodontal treatment. The aim of this study was to evaluate and compare the clinical and inflammatory cytokine effects between scaling and root planing alone, adjunctive azithromycin, or adjunctive amoxicillin plus metronidazole in the treatment of patients with generalised moderate-to-severe chronic periodontitis. It was initially hypothesized that patients receiving scaling and root planing + azithromycin would demonstrate greater reductions in clinical attachment level (greater than or equal to 1 mm) and inflammatory cytokine levels compared to the other treatment groups, after 2 months.

Interventions

Arm 1: Ultrasonic and manual full-mouth scaling and root planing (2 x 90 min sessions within 7 days) alone. Arm 2: Ultrasonic and manual full-mouth scaling and root planing (2 x 90 min sessions within 7 days), plus amoxicillin 500mg and metronidazole 400mg, three times a day for seven days; administered via oral tablets. Arm 3: Ultrasonic and manual full-mouth scaling and root planing (2 x 90 min sessions within 7 days), plus azithromycin 500mg once a day for three days; administered via oral tablet. The intervention drugs were administered by a third party clinician (dental hygienist) with no involvement in the study. Adherence and any adverse events were reported by the patient via an anonymous written survey given out at 1 week follow-up.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

All patients were in good general health and were diagnosed with generalised moderate-to-severe chronic periodontitis based on the current classification of the American Academy of Periodontology: * At least 16 natural teeth (excluding third molars and teeth with advanced caries indicated for extraction). * More than 30% of teeth probing pocket depth greater than or equal to 5mm, clinical attachment level greater than or equal to 3mm, and bleeding on probing at baseline.

Exclusion criteria

* Pregnancy and lactation. * Active tobacco smoking. * Scaling and root planing or antibiotic therapy within the last six months. * Medical disorders that require prophylactic antibiotic coverage or that could influence the progression or treatment of periodontitis * Long term administration of anti-inflammatory or immunosuppressive medications * Positive history of cardiovascular disease * Known hypersensitivity to amoxicillin, metronidazole or amoxicillin.

Outcome results