← Back to Search

Antibiotics for Gum Disease (PAAS Trial)

Phase 3
Recruiting
Led By Georgios Kotsakis, DDS
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of ≥ 20 permanent teeth excluding 3rd molars
Adult who is at least 40 years old
Must not have
Use of systemic antibiotics taken within the previous 3 months prior to enrollment
Medical condition which requires antibiotic prophylaxis prior to dental treatments/visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, re-evaluation (6 weeks), and final study visit (12 months) after intervention.
Awards & highlights

Summary

This trial will study the use of antibiotics in addition to a common dental treatment for gum disease called scaling and root planing. The study aims to see if adding antibiotics to the treatment will be more effective

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical antibiotic-related issues such as digestive discomfort, allergic reactions, or increased resistance to antibiotics over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least 20 permanent teeth, not counting wisdom teeth.
Select...
I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not taken antibiotics in the last 3 months.
Select...
I need antibiotics before any dental work due to a medical condition.
Select...
I have a weakened immune system or chronic sores in my gums.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, re-evaluation (6 weeks), and final study visit (12 months) after intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, re-evaluation (6 weeks), and final study visit (12 months) after intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Probing Depth (PD) in millimeters
Secondary outcome measures
Changes in oral health-related quality of life
Changes in the probability of bleeding on probing (BoP)
Clinical attachment level (CAL) in millimeters
+2 more
Other outcome measures
Treatment-related adverse events

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amoxicillin
2017
Completed Phase 4
~7780
Metronidazole
2011
Completed Phase 4
~3810

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)NIH
302 Previous Clinical Trials
849,071 Total Patients Enrolled
National Dental PBRNUNKNOWN
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
64,838 Total Patients Enrolled
~363 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top