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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

Pivotal Trial

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

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I have at least 20 permanent teeth, not counting wisdom teeth.

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken antibiotics in the last 3 months.

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I need antibiotics before any dental work due to a medical condition.

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I have a weakened immune system or chronic sores in my gums.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, re-evaluation (6 weeks), and final study visit (12 months) after intervention.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Probing Depth (PD) in millimeters

Secondary study objectives

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 study objectives

Treatment-related adverse events

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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