Antibiotics for Gum Disease
(PAAS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Must not be taking: Antibiotics, Disulfiram, Warfarin, others
Disqualifiers: Drug allergy, Recent antibiotics, Immunocompromised, others
Stay on Your Current Meds
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized stage II-III, grades A-C periodontitis in approximately 544 patient participants from about 34 National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used systemic antibiotics in the last 3 months or if you are taking medications that might interact with the trial antibiotics, like disulfiram, warfarin, or oral contraceptives.
What data supports the effectiveness of the drug Amoxicillin / Metronidazole for treating gum disease?
Research shows that using amoxicillin and metronidazole together can help improve the treatment of aggressive gum disease by reducing harmful bacteria and improving gum health.
12345Is the combination of amoxicillin and metronidazole safe for humans?
A study analyzing five clinical trials found that there are side effects associated with taking amoxicillin and metronidazole, but it did not specify the nature or severity of these side effects.
46789How does the drug amoxicillin plus metronidazole differ from other treatments for gum disease?
Amoxicillin plus metronidazole is unique because it targets specific bacteria associated with gum disease, particularly in patients with certain microbiologic profiles, and is used alongside standard cleaning procedures to enhance treatment effectiveness.
157810Eligibility Criteria
This trial is for adults at least 40 years old in good general health with generalized stage II-III, grades A-C periodontitis. They must have ≥20 permanent teeth and be willing to undergo treatment and follow-up for 12-15 months. Participants will come from National Dental PBRN practices.Inclusion Criteria
I have at least 20 permanent teeth, not counting wisdom teeth.
I am 40 years old or older.
Willing to comply with all study visits and be available for the duration of the study (12-15 months)
+3 more
Exclusion Criteria
Known drug allergy to any antibiotics or anesthetics
Is currently pregnant or lactating
I need antibiotics before any dental work due to a medical condition.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive scaling and root planing (SRP) with either adjunctive antibiotics (Amoxicillin and Metronidazole) or placebo
10 days
1 visit (in-person) for loading dose, followed by self-administration
Re-evaluation
Participants are assessed for changes in periodontal clinical and patient-reported outcomes
6 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
1 visit (in-person)
Participant Groups
The study tests the effectiveness of using antibiotics Amoxicillin/Metronidazole alongside scaling and root planing (SRP) compared to SRP with a placebo in treating gum disease. It's a large-scale, randomized, controlled trial involving about 544 patients across various dental practices.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test ArmExperimental Treatment2 Interventions
Patient participants in this arm will receive a combination of Amoxicillin 500mg \& Metronidazole 500mg orally (AMXM) as adjuncts along with their scheduled non-surgical periodontal treatment as the study intervention. A loading dose of 1g of Amoxicillin and 1g of Metronidazole will be given 30-60 minutes prior to periodontal treatment. After the loading dose, each patient participant will be instructed to take Amoxicillin 500mg \& Metronidazole 500mg every 8 hours for 10 days.
Group II: Control ArmPlacebo Group1 Intervention
Patient participants in this arm will receive a placebo capsules identical to the study drug capsules along with their scheduled non-surgical periodontal treatment as the placebo comparator in an identical frequency and duration fashion as the active drug group.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlabameBirmingham, AL
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Who Is Running the Clinical Trial?
Rutgers, The State University of New JerseyLead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)Collaborator
National Dental PBRNCollaborator
References
Multilevel Analysis of Non-surgical Periodontal Treatment of Patients with Generalised Aggressive Periodontitis. [2021]To investigate various factors affecting the clinical outcome of nonsurgical periodontal treatment and evaluate the treatment effects of adjunctive amoxicillin and metronidazole (AMX + MET) in patients with generalised aggressive periodontitis (GAgP).
Non-surgical periodontal treatment in conjunction with 3 or 7 days systemic administration of amoxicillin and metronidazole in severe chronic periodontitis patients. A placebo-controlled randomized clinical study. [2018]To evaluate the effect of 3 or 7 days systemic administration of amoxicillin (AMX) and metronidazole (MET) or placebo as adjunct to non-surgical periodontal treatment in severe chronic periodontitis patients.
Amoxicillin/Metronidazole Dose Impact as an Adjunctive Therapy for Stage II - III Grade C Periodontitis (Aggressive Periodontitis) at 3- And 6-Month Follow-Ups: a Systematic Review and Meta-Analysis. [2022]This systematic review and meta-analysis study sought to review the efficacy of amoxicillin/metronidazole dose and duration time in the treatment of stage II - III grade C periodontitis (aggressive periodontitis) after current follow-up.
Clinical and microbiologic evaluation, by real-time polymerase chain reaction, of non-surgical treatment of aggressive periodontitis associated with amoxicillin and metronidazole. [2015]The aim of the present study is to evaluate the clinical and microbiologic changes resulting from non-surgical periodontal treatment associated with amoxicillin and metronidazole in individuals with aggressive periodontitis.
Are there specific benefits of amoxicillin plus metronidazole in Aggregatibacter actinomycetemcomitans-associated periodontitis? Double-masked, randomized clinical trial of efficacy and safety. [2013]It has been suggested that prescription of amoxicillin plus metronidazole in the context of periodontal therapy should be limited to patients with specific microbiologic profiles, especially those testing positive for Aggregatibacter actinomycetemcomitans. The main purpose of this analysis is to determine if patients positive for A. actinomycetemcomitans with moderate to advanced periodontitis benefit specifically from amoxicillin plus metronidazole given as an adjunct to full-mouth scaling and root planing.
Adverse events of metronidazole and amoxicillin: Retrospective analysis of a large data set of five randomized clinical trials. [2022]To evaluate the frequency of side effects associated with intake of metronidazole (MTZ) + amoxicillin (AMX) in periodontal treatment, and to explore associations between these events and patients' features.
Local concentration of systemic amoxicillin and metronidazole in healthy and inflamed gingiva: a comparative in vivo study. [2013]One of the most recommended methods of systemic antibiotic administration in periodontics is the combination of amoxicillin and metronidazole, which has great inhibitory effect on periodontal pathogens. The aim of this study is to determine the local concentrations of these drugs in gingiva and compare its distribution in healthy and inflamed tissues.
The Use of Amoxicillin (500 Mg) Plus Metronidazole (500 Mg) for 7 Days Adds Adjunctive Benefits for Nonsurgical Periodontal Therapy, but Limited Evidence Supports Higher/Longer Dose. [2019]Optimal dose and duration of amoxicillin-plus-metronidazole as an adjunct to nonsurgical periodontal therapy: A systematic review and meta-analysis of randomized, placebo-controlled trials. McGowan K, McGowan T, Ivanovski S. J Clin Periodontol 2018;45:56-67.
Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. [2022]The present investigation aimed to analyse clinical and microbiological effects of systemic administration of metronidazole and amoxicillin combined with the One-Stage-Full-Mouth-Disinfection protocol (OSFMD) in generalized aggressive periodontitis patients (G-AgP).
The effects of adjunctive metronidazole plus amoxicillin in the treatment of generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. [2013]To evaluate the clinical effects of the adjunctive use of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of generalized aggressive periodontitis (GAgP).