PeriodontitisPhase 3PAASNCT06131021
Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
A Phase 3 study testing Amoxicillin and Metronidazole in people with Periodontitis and Periodontal Diseases, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- What is being tested?
- Amoxicillin and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 7 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will recruit patient participants presenting for periodontal treatment within the National Dental PBRN practices participating in this study.
- To be eligible to participate in this study, a potential patient participant must meet all the following criteria:
- Adult who is at least 35 years old.
- Presence of ≥ 15 permanent teeth excluding 3rd molars.
- In good general health as evidenced by medical history (ASA Class I or II) per the practitioner.
- Planned to receive periodontal care for Generalized Periodontitis and a minimum of two quadrants of SRP (CDT code 4341) in practices participating in the National Dental PBRN.
- Willing to comply with all study visits and be available for the duration of the study (12-15 months)
- Willing to provide contact information for self, including a cellular phone number for study text, and one to two emergency contacts to be reached for the follow-up visits and any other study-related matters for the duration of the study.
Who cannot join
- Known drug allergy to any antibiotics or anesthetics.
- Use of systemic antibiotics taken within the previous 3 months prior to enrollment.
- Medical condition which requires antibiotic prophylaxis prior to dental treatments/visits.
- Current use of medications that, in the opinion of the practitioner, may cause adverse effects with AMXM (such as disulfiram, warfarin, and oral contraceptives).
- History of any periodontal therapy (including SRP D4341, D4342) within the last 6 months prior to enrollment.
- Is currently pregnant or lactating per patient participant self-report.
- Is considered immunocompromised, in the opinion of the practitioner (including diseases and conditions such as HIV/AIDS, immunosuppressive drug therapy and/or radiation), or has chronic mucosal lesions (e.g. pemphigus vulgaris) affecting the gingiva.
- Has Diabetes mellitus with an HbA1c score of >/= 10% within the past 3 months as per patient participant self-report.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical 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 grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 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.
Read the detailed description
Précis: 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 grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 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.
Objectives and Outcomes: Primary: The primary objective will assess the effectiveness of SRP plus adjunctive antibiotics compared to SRP with placebo in periodontitis individuals from baseline to 6 weeks following non-surgical periodontal therapy (NSPT) as determined by changes in site-level periodontal probing depth (PD).
Secondary: To assess changes in: i) gingival inflammation (measured by bleeding on probing (BoP)), ii) periodontal tissue attachment (measured by clinical attachment level (CAL)), iii) reduction in diseased sites (measured by remaining sites with maximum probing depth ≥5 mm), and iv) disease remission (measured by number of participants with ≤4 sites with PD≥ 5mm); comparing SRP plus AMXM to SRP with a placebo adjunctive in periodontitis individuals from baseline to re-evaluation (6 weeks) to final (4-12 month) study visit following intervention. Also, assess changes in periodontal probing depth from baseline measurements to final visit (4-12 months) following intervention. The patient-reported impact of periodontal treatment (measured by the Oral Health Impact Profile-5 (OHIP-5)) and treatment-related adverse events between groups will also be assessed.
Population: A sample size of 214 patient participants enrolled from up to 34 National Dental PBRN practices will be enrolled for adequate power. All patient participants are indicated to receive SRP and have been diagnosed with periodontitis stages II-III, grades A-C.
Description of Intervention: The intervention will involve either SRP, which is considered the standard of care treatment for debriding root surfaces, in conjunction with 500 mg Amoxicillin and 500mg Metronidazole orally every 8 hours (q8h) for ten days following SRP or SRP with placebo.
- Conditions
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- Being tested
- Amoxicillin, Metronidazole, Placebo
- Keywords
- Antibiotics, Amoxicillin, Metronidazole
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Amoxicillin belongs to the penicillin category, and it is a commonly prescribed broad-spectrum antibiotic as a periodontal treatment adjunct.
MetronidazoleDrug
Metronidazole is effective against anaerobic bacteria, and it is often combined with Amoxicillin for an enhanced antimicrobial effect as a periodontal treatment adjunct.
PlaceboOther
Placebo in identical drug-safe vials with capsules identical in appearance to the active drugs
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | 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. Receives: Drug: Amoxicillin; Drug: Metronidazole |
| Control Arm | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth (PD) in millimeters
The primary outcome of treatment effectiveness will be assessed by full-mouth probing depth (PD) from baseline to 6 weeks following intervention. Full-mouth PD measurements (excluding 3rd molars) will be obtained utilizing a UNC 15mm periodontal probe.
Measured: Baseline to Re-evaluation (6 weeks)
Secondary outcomes (6)
Clinical attachment level (CAL) in millimeters
This secondary objective will be assessed by clinical attachment level (CAL) changes from baseline to 6 weeks, and from baseline to 4-12 months post-intervention, adjusting for baseline CAL. CAL is a disease-related characteristic. Half-mouth CAL in millimeters (excluding 3rd molars) will be obtained utilizing a UNC 15mm periodontal probe to measure base of pocket to cementoenamel junction (CEJ).
Measured: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Changes in the probability of bleeding on probing (BoP)
This secondary objective will assess changes in the probability of observing BoP, a common surrogate for gingival inflammation, at 6 weeks and at 4-12 months post intervention, adjusting for baseline BoP. BoP is assessed in conjunction with probing depths using a UNC 15mm periodontal probe and is recorded as a binary outcome per site, i.e., is the site bleeding? Yes/No.
Measured: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Reduction in diseased sites
Reduction in diseased sites is a calculated variable from PD. We will assess the probability a site is observed with residual PD≥ 5 mm at 6 weeks and at 4-12 months post-intervention, adjusting for its baseline PD. PD≥ 5mm; The maximum probing depth per tooth will be recorded as ≥5 mm (yes/no).
Measured: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Disease remission
Disease remission is defined as the number of study patient participants who have ≤4 sites with PD≥5mm. Patient participants will be considered 'in remission' if they display ≤4 sites with PD≥ 5mm; This is a dichotomization from the summation of PD≥ 5mm within person.
Measured: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Changes in oral health-related quality of life
To evaluate oral health-related quality of life, the Oral Health Impact Profile (OHIP-5) will be utilized. OHIP-5 sum score based upon self-reported responses will be assessed. The OHIP-5 has 5 questions ranging from 0 = never to 4 = very often with higher scores translating to a worse outcome.
Measured: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Probing Depth (PD) in millimeters at final visit
This secondary outcome of treatment effectiveness will be assessed by the change in full-mouth probing depth (PD) from baseline to 4-12 months post-intervention. Full-mouth PD measurements (excluding 3rd molars) will be obtained utilizing a UNC 15mm periodontal probe.
Measured: Baseline, Final study visit (4-12 months) after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start25 Apr 2024
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size will be a target of approximately 214 patient participants enrolled from up to 34 National Dental PBRN practices. All patient participants are indicated to receive SRP and have been diagnosed with periodontitis. A double-blinded patient participant-randomized design is used to assign patient participants to SRP plus AMXM versus SRP plus placebo prior to treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Dental PBRN
- Responsible party
- Principal investigator, Georgios A. Kotsakis, DDS, MS, Rutgers, The State University of New Jersey
- Investigators
- Georgios Kotsakis, DDS, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131021
- Sponsor's protocol ID
- Pro2023001347
- Other IDs
- 4UH3DE031129-02
- Acronym
- PAAS
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice: A PBRN Clinical Trial
- ClinicalTrials.gov ID
- NCT06131021
- Acronym / sponsor ID
- PAAS / Pro2023001347
- Conditions
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- Keywords
- Antibiotics, Amoxicillin, Metronidazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Dental PBRN
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 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.
Detailed description
Précis: 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 grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 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.
Objectives and Outcomes: Primary: The primary objective will assess the effectiveness of SRP plus adjunctive antibiotics compared to SRP with placebo in periodontitis individuals from baseline to 6 weeks following non-surgical periodontal therapy (NSPT) as determined by changes in site-level periodontal probing depth (PD).
Secondary: To assess changes in: i) gingival inflammation (measured by bleeding on probing (BoP)), ii) periodontal tissue attachment (measured by clinical attachment level (CAL)), iii) reduction in diseased sites (measured by remaining sites with maximum probing depth ≥5 mm), and iv) disease remission (measured by number of participants with ≤4 sites with PD≥ 5mm); comparing SRP plus AMXM to SRP with a placebo adjunctive in periodontitis individuals from baseline to re-evaluation (6 weeks) to final (4-12 month) study visit following intervention. Also, assess changes in periodontal probing depth from baseline measurements to final visit (4-12 months) following intervention. The patient-reported impact of periodontal treatment (measured by the Oral Health Impact Profile-5 (OHIP-5)) and treatment-related adverse events between groups will also be assessed.
Population: A sample size of 214 patient participants enrolled from up to 34 National Dental PBRN practices will be enrolled for adequate power. All patient participants are indicated to receive SRP and have been diagnosed with periodontitis stages II-III, grades A-C.
Description of Intervention: The intervention will involve either SRP, which is considered the standard of care treatment for debriding root surfaces, in conjunction with 500 mg Amoxicillin and 500mg Metronidazole orally every 8 hours (q8h) for ten days following SRP or SRP with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The sample size will be a target of approximately 214 patient participants enrolled from up to 34 National Dental PBRN practices. All patient participants are indicated to receive SRP and have been diagnosed with periodontitis. A double-blinded patient participant-randomized design is used to assign patient participants to SRP plus AMXM versus SRP plus placebo prior to treatment.
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: Amoxicillin, Drug: MetronidazolePatient 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. |
| Control Arm | Placebo comparator | Other: PlaceboPatient 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The study will recruit patient participants presenting for periodontal treatment within the National Dental PBRN practices participating in this study.
- To be eligible to participate in this study, a potential patient participant must meet all the following criteria:
- Adult who is at least 35 years old.
- Presence of ≥ 15 permanent teeth excluding 3rd molars.
- In good general health as evidenced by medical history (ASA Class I or II) per the practitioner.
Key exclusion criteria (8 listed)
- Known drug allergy to any antibiotics or anesthetics.
- Use of systemic antibiotics taken within the previous 3 months prior to enrollment.
- Medical condition which requires antibiotic prophylaxis prior to dental treatments/visits.
- Current use of medications that, in the opinion of the practitioner, may cause adverse effects with AMXM (such as disulfiram, warfarin, and oral contraceptives).
- History of any periodontal therapy (including SRP D4341, D4342) within the last 6 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmoxicillinAmoxicillin belongs to the penicillin category, and it is a commonly prescribed broad-spectrum antibiotic as a periodontal treatment adjunct. | Drug | Test Arm |
| MetronidazoleMetronidazole is effective against anaerobic bacteria, and it is often combined with Amoxicillin for an enhanced antimicrobial effect as a periodontal treatment adjunct. | Drug | Test Arm |
| PlaceboPlacebo in identical drug-safe vials with capsules identical in appearance to the active drugs | Other | Control Arm |
Primary outcome
Probing Depth (PD) in millimeters
Time frame: Baseline to Re-evaluation (6 weeks)
The primary outcome of treatment effectiveness will be assessed by full-mouth probing depth (PD) from baseline to 6 weeks following intervention. Full-mouth PD measurements (excluding 3rd molars) will be obtained utilizing a UNC 15mm periodontal probe.
6 secondary outcomes
Clinical attachment level (CAL) in millimeters
Time frame: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Changes in the probability of bleeding on probing (BoP)
Time frame: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Reduction in diseased sites
Time frame: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Disease remission
Time frame: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Changes in oral health-related quality of life
Time frame: Baseline, Re-evaluation (6 weeks), and Final study visit (4-12 months) after intervention.
Probing Depth (PD) in millimeters at final visit
Time frame: Baseline, Final study visit (4-12 months) after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Kotsakis, DDS principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin and Metronidazole in people with Periodontitis and Periodontal Diseases, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing Depth (PD) in millimeters (time frame: Baseline to Re-evaluation (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.