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.
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
- Conditions the study is for
- Periodontal Diseases, Antibiotics, Pharmacokinetics
- 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.
Switzerland1 site, 1 recruiting
- 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
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.
- Conditions
- Periodontal Diseases, Antibiotics, Pharmacokinetics
- 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 group | Role | What they receive |
|---|---|---|
| Amoxicilline and Metronidazole for 7 days | Active comparator | Drug: 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 days | Active comparator | Drug: 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 days | Active comparator | Drug: 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.
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)
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
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
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
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.
- First posted17 Dec 2020
- Study start1 Sep 2021
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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 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)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Catherine Giannopoulou, University of Geneva, Switzerland
- Investigators
- Catherine Giannopoulou, Dr med dent, Principal investigator, University Clinics of Dental Medicine, University of Geneva
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04669717
- Acronym / sponsor ID
- AMA / BASEC 2020-01074
- Conditions
- Periodontal Diseases, Antibiotics, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Dec 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Randomized, 3-arm parallel group, single-blind, comparative superiority and exploratory clinical trial with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Amoxicilline and Metronidazole for 7 days | Active comparator | Drug: 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 daysDrug: 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 |
| Amoxicilline and Metronidazole for 3 days | Active comparator | Drug: 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 daysDrug: 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 |
| Azithromycine for 3 days | Active comparator | Drug: 1/d 500 mg Azithromycine Pfizer for 3 daysDrug: AZITHROMYCIN Pfizer cpr pell 500mg, Pfizer PFE Switzerland GmbH 1/d 500mg for 3 days Systemic antibiotics after sub gingival mechanical debridement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 daysAlso: AMOXICILLINE Sandoz cpr pell 500 mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500 mg, Sanofi-Aventis ( Suisse) SANon-surgical periodontal therapy and radnomly administration of the antibiotics | Drug | Amoxicilline and Metronidazole for 7 days |
| 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 daysAlso: AMOXICILLINE Sandoz cpr pell 500 mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500 mg, Sanofi-Aventis ( Suisse) SANon-surgical periodontal therapy and radnomly administration of the antibiotics | Drug | Amoxicilline and Metronidazole for 3 days |
| 1/d 500 mg Azithromycine Pfizer for 3 daysAlso: AZITHROMYCIN Pfizer cpr pell 500mg, Pfizer PFE Switzerland GmbHNon-surgical periodontal therapy and radnomly administration of the antibiotics | Drug | Azithromycine for 3 days |
Primary outcome
The concentration of AMO+MET and AZI in GCF, saliva and serum
Time frame: At Day 0,2,4,8 post-dose
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
4 secondary outcomes
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.
Time frame: At Month 3 and Month 6 post-intervention
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.
Time frame: At Month 3 and Month 6 post-intervention
Number of participant per treatment arm with adverse events as a mesure of safety.
Time frame: At Day 2, Day 4 and Day 8 post-intervention
Patient's compliance will be evaluated
Time frame: At Day 8 after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 26604272Giannopoulou 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.
- 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.
Catherine Giannopoulou, Dr med dent principal investigator
University Clinics of Dental Medicine, University of Geneva
1 site in 1 country: see every site and its status.
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.