Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment (AZITHROPARO)
Primary Purpose
Severe Chronic Periodontitis
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Non-surgical periodontal treatment and azithromycin treatment
Non-surgical periodontal treatment and placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Severe Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Les Hôpitaux Universitaires de StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Azithromycin
Placebo
Arm Description
62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days
62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days
Outcomes
Primary Outcome Measures
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm
Secondary Outcome Measures
Full Information
NCT ID
NCT04198649
First Posted
December 12, 2019
Last Updated
August 18, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT04198649
Brief Title
Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
Acronym
AZITHROPARO
Official Title
Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 2, 2024 (Anticipated)
Study Completion Date
November 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
62 patients Non-surgical periodontal treatment and two 250mg azithromycin tablets one time daily for 3 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
62 patients Non-surgical periodontal treatment and two 250mg starch tablets one time daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Non-surgical periodontal treatment and azithromycin treatment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Non-surgical periodontal treatment and placebo treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of subjects with failure of treatment, failure defined by persistence of at least one residual periodontal pocket > 5mm
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Luc Davideau
Phone
03.88.11.69.47
Email
jean.luc.davideau@chru-strasbourg.fr
Facility Information:
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Luc U Davideau, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment
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