The Periodontal Adjunctive Antibiotics Study (PAAS) is recruiting oral health providers

• Studies

The PAAS study will evaluate the effectiveness of adjunctive antibiotics in the treatment of periodontal disease. The study is a randomized clinical trial where 36 practitioners from the South Central, Southwest, and Western Nodes of the National Dental PBRN will recruit 16 to 22 patients with periodontitis in each practice for a total of 544 patients.

Patients with periodontitis will be randomly assigned to either receive scaling and root planing (SRP) plus adjunctive antibiotics or SRP plus placebo. The study adjunctive antibiotics are Metronidazole 500 mg and Amoxicillin 500 mg every 8 hours for 10 days. The interventions may be provided by a dentist or hygienist. Each individual patient will participate in the study for 12 months, and the practice participation in the study will last approximately 21 months, depending on the practice’s enrollment schedule.

WHY IS THIS STUDY BEING DONE?

Antibiotic stewardship calls for optimizing antibiotic prescribing to effectively treat infections, and to reduce antibiotic misuse to prevent the development of antibiotic-resistant microbial strains.

Historically, antibiotics have been an integral part of periodontal disease treatment. The combined use of Amoxicillin, a broad spectrum antibacterial of the penicillin family, and Metronidazole, active against most anaerobic bacteria and some protozoans, have become the most prescribed antibiotic adjunct in the treatment of chronic periodontal disease. However, a systematic review on nonsurgical treatment of periodontitis[1] revealed that only small-scale clinical trials were available to support recommending antibiotics to severe or aggressive periodontitis cases. The ADA expert panel[2] recommendation for antibiotics as adjunctive therapies to SRP was considered of weak strength and suggested that larger pragmatic clinical trials would benefit dental professionals in their clinical decision making.

WHAT IS EXPECTED OF YOU?

• Recruit approximately 16 to 22 adult patients with periodontitis
• Administer a screening form, obtain informed consent, and assist participant with completing surveys
• Record full mouth probing depth, bleeding on probing, and gingival recession at baseline, 6-week and 1-year follow-up visits and upload the periodontal chart
• Dispense study antibiotics or placebo to your patient in conjunction with scaling and root planing (SRP) treatment
• Counsel patients about their oral hygiene habits
• Complete post-visit surveys at early re-evaluation at approximately 6-weeks after SRP and at the 1-year re-evaluation.

WHICH PATIENTS CAN PARTICIPATE?

Patients can participate if they:

• Are 40 years old or older.
• Are being treated for periodontal disease stage II-III, grades A-C (previously generalized moderate-to-severe periodontitis).
• Have not used systemic antibiotics in the previous 3 months.
• Have not had periodontal therapy (including SPR D4341, D4342) in the previous 6 months.

WHAT IS EXPECTED OF MY PATIENTS?

• Complete screening forms upon arrival to your office.
• Be willing to be randomly assigned to receive a 10-day course of either placebo or study antibiotics and to take the assigned pills every 8 hours for 10 days
• Receive scaling and root planing and the antibiotic/placebo regime
• Complete short web-based surveys at baseline, 10 days after baseline, and at the 6-week and 1-year follow-up visits.

Dr. Georgios Kotsakis and Dr. Marcelo Araujo discuss antibiotics in perio and the new PAAS study

WHY SHOULD YOU PARTICIPATE?

• Advance the science and practice of Periodontics
• Participating dentists or hygienists will receive a total of $250 remuneration per participant: $100 baseline, $100 re-evaluation and $50 at the final visit with a remuneration of $4,000 upon enrolling the target sample size of N=16 participants (up to a maximum remuneration of $5,500 upon enrolling 22 participants)
• Patients will be compensated $50 per study visit

CONTACT US TO PARTICIPATE 

If you are interested in participating and is willing to use adjunctive antibiotics for periodontal treatment in your dental office, you may be eligible to participate.

Email us and a node coordinator will contact you for the next steps.

[1] Smiley CJ, Tracy SL, Abt E, Michalowicz BS, John MT, Gunsolley J, Cobb CM, Rossmann J, Harrel SK, Forrest JL, Hujoel PP, Noraian KW, Greenwell H, Frantsve-Hawley J, Estrich C, Hanson N. Systematic review and meta-analysis on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015 Jul;146(7):508-24.e5. doi: 10.1016/j.adaj.2015.01.028. PMID: 26113099.

[2] Smiley CJ, Tracy SL, Abt E, Michalowicz BS, John MT, Gunsolley J, Cobb CM, Rossmann J, Harrel SK, Forrest JL, Hujoel PP, Noraian KW, Greenwell H, Frantsve-Hawley J, Estrich C, Hanson N. Evidence-based clinical practice guideline on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015 Jul;146(7):525-35. doi: 10.1016/j.adaj.2015.01.026. PMID: 26113100.