Severe Chronic PeriodontitisPhase 3AZITHROPARONCT04198649
Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
A Phase 3 study testing Non-surgical periodontal treatment and azithromycin treatment in people with Severe Chronic Periodontitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket> 5mm at 6 months Secondary purpose: Evaluate the effect of azithromycin on the persistence of pathological… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Severe Chronic Periodontitis
- What is being tested?
- Non-surgical periodontal treatment and azithromycin treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2021to 2 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with severe generalized chronic periodontitis (loss of attachment ≥ 5mm at > 30% sites) (AAP classification 1999) and periodontal pockets >5mm on at least 5% of sites
- presence of bleeding on probing (≥ 30%)
- male or female subject older than 35 Years
- patient with at least 15 teeth including at least 2 molars (excluding wisdom teeth)
- patient with social assurance
- voluntary patient who signed informed consent
Who cannot join
- Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or one of the excipients used in this study, association with ergot derivatives Rye, Cisapride, colchicine, and severe hepatic deficiencies. Other contraindications are for patients at risk of cardiac arrhythmia (diagnosis of QT interval prolongation and/or concomitant treatments, electrolytic disorder (hypokalemia, hypomagnesemia, cardiac arrhythmia, heart failure), severe renal failure, and drug associations (Antivitamin K, statins)
- Patient with aggressive periodontitis (AAP classification 1999)
- Patient smoking more than 10 cigarettes/day
- Patient with endocarditis risk or requiring antibiotic prophylaxis
- Patient with antibiotic treatment within 6 months prior to periodontal examination
- Patient with anti-inflammatory treatment in the month preceding periodontal examination and/or anti-inflammatory treatment of more than 3 consecutive days in the 3 months preceding periodontal examination
Show all 18Show fewer
- Patient following or having followed a drug treatment (cyclosporine and other anti-rejection drugs, antiepileptic, calcium inhibitor) influencing periodontal status
- Patient with pathologies influencing periodontal status and/or systemic or local inflammatory response, such as diabetes, infectious stomatitis or not, diseases inflammatory and autoimmune, immuno-depression
- Patient with prolonged oral hygiene disability (physical/psychic impossibility of brushing teeth)
- Patient with impaired oral condition (untreated cavities, non-dental teeth rehabilitated), dental infections whose management requires antibiotic treatment within 6 months
- Patient having specialized periodontal treatment, root planning, or a periodontal surgical treatment in the year prior to the examination
- Pregnant woman or breastfeeding
- Patient with repeated chronic infections (more than 3 times per year) requiring antibiotic treatment
- Patient who had oral antiseptic treatment in the previous month
- Patient included in another intervention research protocol or in periods of exclusion (participation in an observational study remains possible)
- Patient with high bleeding risk and/or INR > 4.
- Patient under guardianship and under protection of justice
- Patient unable to cooperate or understand the instructions related to the study and care
Trial locations and contacts
1 site in 1 country.
About this study
Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket> 5mm at 6 months
Secondary purpose:
- Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets > 5mm during non-surgical treatment of severe chronic periodontitis at 3 months and 6 months
- Evaluate the effect of azithromycin on the changes of clinical signs, periopathogen levels, expression of macrolides resistance genes, and expression of antimicrobial peptides (PAMs) during treatment of severe chronic periodontitis at 3 months and 6 months
- Assess therapeutic observance and side effects of antibiotic treatment
- Assess at 3 and 6 months the potential interactions of local, bacterial (periopathogen and resistance gene) clinical factors, and host defense (PAMs) with the effect of azithromycin, on failure proportion of severe chronic periodontitis non-surgical treatment
- Conditions
- Severe Chronic Periodontitis
- Being tested
- Non-surgical periodontal treatment and azithromycin treatment, Non-surgical periodontal treatment and placebo treatment
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatment and azithromycin treatmentDrug
Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Drug: two 250mg azithromycin tablets one time daily for 3 days after scaling and root planning sessions
Non-surgical periodontal treatment and placebo treatmentOther
Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Placebo: two 250mg starch tablets one time daily for 3 days after scaling and root planning sessions
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | 62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days Receives: Drug: Non-surgical periodontal treatment and azithromycin treatment |
| Placebo | Placebo comparator | 62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days Receives: Other: Non-surgical periodontal treatment and placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start2 Nov 2021
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198649
- Sponsor's protocol ID
- 6996
- Acronym
- AZITHROPARO
- Status last verified
- Aug 2024
- First submitted
- 12 Dec 2019
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
- ClinicalTrials.gov ID
- NCT04198649
- Acronym / sponsor ID
- AZITHROPARO / 6996
- Conditions
- Severe Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 13 Dec 2019 (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.
Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket> 5mm at 6 months
Secondary purpose:
- Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets > 5mm during non-surgical treatment of severe chronic periodontitis at 3 months and 6 months
- Evaluate the effect of azithromycin on the changes of clinical signs, periopathogen levels, expression of macrolides resistance genes, and expression of antimicrobial peptides (PAMs) during treatment of severe chronic periodontitis at 3 months and 6 months
- Assess therapeutic observance and side effects of antibiotic treatment
- Assess at 3 and 6 months the potential interactions of local, bacterial (periopathogen and resistance gene) clinical factors, and host defense (PAMs) with the effect of azithromycin, on failure proportion of severe chronic periodontitis non-surgical treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Non-surgical periodontal treatment and azithromycin treatment62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days |
| Placebo | Placebo comparator | Other: Non-surgical periodontal treatment and placebo treatment62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with severe generalized chronic periodontitis (loss of attachment ≥ 5mm at > 30% sites) (AAP classification 1999) and periodontal pockets >5mm on at least 5% of sites
- presence of bleeding on probing (≥ 30%)
- male or female subject older than 35 Years
- patient with at least 15 teeth including at least 2 molars (excluding wisdom teeth)
- patient with social assurance
Key exclusion criteria (18 listed)
- Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or one of the excipients used in this study, association with ergot derivatives Rye, Cisapride, colchicine, and severe hepatic deficiencies. Other contraindications are for patients at risk of cardiac arrhythmia (diagnosis of QT interval prolongation and/or concomitant treatments, electrolytic disorder (hypokalemia, hypomagnesemia, cardiac arrhythmia, heart failure), severe renal failure, and drug associations (Antivitamin K, statins)
- Patient with aggressive periodontitis (AAP classification 1999)
- Patient smoking more than 10 cigarettes/day
- Patient with endocarditis risk or requiring antibiotic prophylaxis
- Patient with antibiotic treatment within 6 months prior to periodontal examination
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 |
|---|---|---|
| Non-surgical periodontal treatment and azithromycin treatmentProcedure: periodontal treatment: oral hygiene instruction, scaling and root planning Drug: two 250mg azithromycin tablets one time daily for 3 days after scaling and root planning sessions | Drug | Azithromycin |
| Non-surgical periodontal treatment and placebo treatmentProcedure: periodontal treatment: oral hygiene instruction, scaling and root planning Placebo: two 250mg starch tablets one time daily for 3 days after scaling and root planning sessions | Other | Placebo |
Primary outcome
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm
Time frame: At 6 months
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non-surgical periodontal treatment and azithromycin treatment in people with Severe Chronic Periodontitis, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 20 Aug 2024. 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 France. 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 was stopped early (reason given: not enough patients). Results are not available in the source record.
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?
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm (time frame: At 6 months). 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 20 Aug 2024.