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Periodontal DiseasesPhase 4AMANCT04669717

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies

A Phase 4 study testing 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days, 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days and 1/d 500 mg Azithromycine Pfizer for 3 days in people with Periodontal Diseases and Antibiotics, run by University of Geneva, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days, 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days and 1/d 500 mg Azithromycine Pfizer for 3 days
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2021to 1 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Informed Consent as documented by signature
  • Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy
  • Presence of at least 30% of the teeth in the mouth with PD>6mm and BOP

Who cannot join

  • Persons with systemic illnesses (uncontrolled diabetes mellitus, cancer, human immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
  • Pregnancy or lactation
  • Persons who had taken AB within the previous 2 months
  • Persons who are taking nonsteroidal anti-inflammatory drugs
  • Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides
  • Previous periodontal therapy the last 1 year
Show all 10Show fewer
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow due to language problems, psychological disorders, dementia, etc. of the participant
  • Participants not willing to attend regular dental maintenance visits and follow-up evaluations
  • Participation in another study with investigational drug within the 30 days preceding and during the present study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Catherine Giannopoulou, Dr med dent contact

0041223794068

ekaterini.giannopoulou@unige.ch

Alkisti Zekeridou, Dr med dent contact

0041223794031

alkisti.zekeridou@unige.ch

Switzerland1 site, 1 recruiting
  • University of Geneva, University Clinics of Dental Medicine

    Geneva, Canton of Geneva, 1205

    Catherine Giannopoulou, Dr med dent, 022 379 40 68, ekaterini.giannopoulou@unige.ch

    Alkisti Zekeridou, Dr med dent, 022 379 40 30, alkisti.zekeridou@unige.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Pharmacokinetic Considerations and Dosing Strategies of Amoxicillin and Metronidazole or Azithromycin as Adjunct to Non-surgical Periodontal Therapy. A Randomized,6-month, Parallel-group, Clinical Trial.

Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). This procedure can reduce the level of pathogenic bacteria but it can not eradicate them. In severe cases, for the complete resolution of the disease, the elimantion of certain species of bacteria is needed. In order to achieve that, the combination of different regimens of antibiotics adjunctive to the mechanical treatment has been proposed. However, dosage and duration of antimicrobial therapy should be optimal and not excessive as issues may arise related to increased antimicrobial resistance in the population and the individual due to habitual prescription of wide-spectrum antibiotic regimens, horizontal gene transfer and genetic mutation.

In the present study, in an effort to optimize the dosage and duration of the antimicrobial regimen, we will determine the pharmacokinetics (PK) and pharmacodynamic (PD) properties of the MET-AMO combination and of AZI in Gingival Crevicular Fluid (GCF), saliva and serum in severe periodontitis patients during and after either a 3-day or a 7-day course of treatment.

Read the detailed description

This is a randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial of 44 months involving 45 patients with periodontitis attending the Division of Regenarative Dental Medecine and Periodontology of the University of Geneva. First, a routine clinical and radiographic periodontal examination will be conducted by a periodontist. Treatment will be done in 2 appointments by mechanical debridement of the diseased sites by two experienced clinicians. At the end of the treatment, one third of the patients will be assigned for treatment with 500mgAMO+ 500mgMET 3 times a day during 1 week, one third for treatment with 500mgAMO+ 500mgMET 3 times a day during 3 days and the last third for treatment with 500mg AZI once a day for 3 days.

Clinical samples will be taken at Days 0, 2, 4 and 8 after the start of the antibiotic administration . Gingival Crevicular Fluid (GCF) will be collected from four sites with paperpoints, blood sample by finger puncture, unstimulated saliva and subgingival plaque from four sites with paper points. The concentration and duration effect of AMO+MET and AZI in GCF, saliva and serum will be assessed in the Laboratory of Clinical Pharmacology at the University Hospital of Lausanne (CHUV) by high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The microbiological effect on 6 selected organisms will be assessed by RT-PCR at 3 and 6 months after treatment. The clinical results will be evaluated 6 months later. The study duration for the patient will be approximately 8 months.

All adverse events (AE) and all serious adverse events (SAEs) will be recorded and addressed.

Being tested
3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days, 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days, 1/d 500 mg Azithromycine Pfizer for 3 days
Medical subject headings
Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 daysDrug

    Also called AMOXICILLINE Sandoz cpr pell 500 mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500 mg, Sanofi-Aventis ( Suisse) SA

    Non-surgical periodontal therapy and radnomly administration of the antibiotics

  • 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 daysDrug

    Also called AMOXICILLINE Sandoz cpr pell 500 mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500 mg, Sanofi-Aventis ( Suisse) SA

    Non-surgical periodontal therapy and radnomly administration of the antibiotics

  • 1/d 500 mg Azithromycine Pfizer for 3 daysDrug

    Also called AZITHROMYCIN Pfizer cpr pell 500mg, Pfizer PFE Switzerland GmbH

    Non-surgical periodontal therapy and radnomly administration of the antibiotics

Study groups in NCT04669717
Study groupRoleWhat they receive
Amoxicilline and Metronidazole for 7 daysActive comparatorDrug: AMOXICILLINE Sandoz cpr pell 500mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500mg, Sanofi-Aventis ( Suisse) SA, 3/d for 7 days Systemic antibiotics after sub gingival mechanical debridement
Receives: Drug: 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days
Amoxicilline and Metronidazole for 3 daysActive comparatorDrug: AMOXICILLINE Sandoz cpr pell 500mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500mg, Sanofi-Aventis ( Suisse) SA, 3/d for 3 days Systemic antibiotics after sub gingival mechanical debridement
Receives: Drug: 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days
Azithromycine for 3 daysActive comparatorDrug: AZITHROMYCIN Pfizer cpr pell 500mg, Pfizer PFE Switzerland GmbH 1/d 500mg for 3 days Systemic antibiotics after sub gingival mechanical debridement
Receives: Drug: 1/d 500 mg Azithromycine Pfizer for 3 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The concentration of AMO+MET and AZI in GCF, saliva and serum

    The concentration of the drugs will be assessed in samples of gingival crevicular fluid, saliva and serum at days 0, 2, 4 and 8 after the start of the antibiotic administration.The concentration of the studied antibiotics in the different fluids will be expressed as ng/ml

    Measured: At Day 0,2,4,8 post-dose

Secondary outcomes (4)
  1. Differences between the three treatment arms in the proportion of participants classed as treatment success at 6 months; defined as absence of sites with PD ≥ 5 mm and concomitant bleeding on probing.

    Comparisons between groups assessed at 3 and 6 months after treatment

    Measured: At Month 3 and Month 6 post-intervention

  2. Differences between the three treatment arms in the levels of 6 organisms in subgingival plaque samples. For those bacteria with a threshold of >1000cells/ml, results will be expressed as median counts.

    Comparisons between groups will be assessed at 3 and 6 months after treatment

    Measured: At Month 3 and Month 6 post-intervention

  3. Number of participant per treatment arm with adverse events as a mesure of safety.

    Adverse events will be collected from the start of study treatment and until the end of the study (at 6 months evaluation)

    Measured: At Day 2, Day 4 and Day 8 post-intervention

  4. Patient's compliance will be evaluated

    Compliance will be evaluated by pill count at the end of the antibiotherapy.

    Measured: At Day 8 after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start1 Sep 2021
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial with 1:1 allocation ratio.
Masking
Single blind
Who is masked
Investigator
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669717
Sponsor's protocol ID
BASEC 2020-01074
Acronym
AMA
Status last verified
Apr 2026
First submitted
20 Nov 2020
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Giannopoulou C, Cionca N, Almaghlouth A, Cancela J, Courvoisier DS, Mombelli A. Systemic Biomarkers in 2-Phase Antibiotic Periodontal Treatment: A Randomized Clinical Trial. J Dent Res. 2016 Mar;95(3):349-55. doi: 10.1177/0022034515618949. Epub 2015 Nov 24.

    PubMed 26604272

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days, 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days and 1/d 500 mg Azithromycine Pfizer for 3 days in people with Periodontal Diseases and Antibiotics, run by University of Geneva, Switzerland at 1 site in Switzerland.

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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 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 Switzerland. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine Giannopoulou, Dr med dent (0041223794068, ekaterini.giannopoulou@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The concentration of AMO+MET and AZI in GCF, saliva and serum (time frame: At Day 0,2,4,8 post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669717, which also lists 1 linked publication.

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 29 Apr 2026.

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