PeriodontitisNCT03862456
Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis
A study testing Azithromycin and Metronidazole in people with Periodontitis and Surgery, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Surgery
- What is being tested?
- Azithromycin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jul 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of periodontitis (stages III or IV) that may require periodontal surgery
- Have at least 10 teeth in function, excluding third molars.
- Present locations with probing depth (PS)> 6 mm in at least 30% of the teeth.
- Present radiographic evidence of moderate-severe bone loss in at least 30% of the dentition.
- Detection of P. gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planning visit and processed by culture.
- Systemically healthy patients.
Who cannot join
- Pregnant or lactating women.
- Presenting systemic pathology and / or taking medication that may affect the periodontal situation and / or patients requiring antibiotic prophylaxis.
- Have received systemic antimicrobial treatment in the previous 6 months.
- Have received periodontal treatment in the 6 months prior to the beginning of the study.
- Patients allergic to metronidazole, or to any of the components of commercial formulations thereof (Flagyl®).
- Patients allergic to azithromycin, or to any of the components of commercial formulations thereof (Zithromax®).
- Patients who refuse to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Microbiological Comparison of Two Different Systemic Antimicrobials (Azithromycin Versus Metronidazole) as Adjuncts to Periodontal Surgery in the Treatment of P.Gingivalis Periodontitis Patients
The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological benefits.
Read the detailed description
Design: randomized, parallel and triple blind clinical trial
Sample: Patients with periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited. 25 patients were randomized to the test group (periodontal surgery + azithromycin) and another 25 subjects to the control group (periodontal surgery + metronidazole).
Study visits:
- Examiner calibration
- Recruitment of patients. Screening. Data collection (clinical and microbiological variables).
- Phase I.
- Non-surgical periodontal treatment (2 visits).
- Reevaluation at 6 weeks. Data collection (clinical and microbiological variables). Identification of study candidate patients (Patients with probing pocket depth > 5 mm and positive to Porphyromonas gingivalis). Randomization of study groups.
- Phase II. Surgical periodontal treatment.
- Periodontal surgery sessions. In the last surgery, the antibiotic test (azithromycin) or metronidazole (control) is administered according to randomization.
- Suture removal 1 week after performing periodontal surgery. Data collection 1 week after antibiotic consumption with the last surgery (patient-centered variables on the side effects of antibiotics).
- Re-evaluation of the surgical phase at 6 weeks after the last surgery session. Data collection (clinical variables).
- Phase III. Periodontal maintenance.
- Maintenance 1 (3 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 2 (6 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 3 (9 months post surgery). Data collection (Clinical variables).
- Maintenance 4 (12 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 5 (4 years post surgery). Data collection (Clinical and microbiological variables).
- Conditions
- Periodontitis, Surgery
- Being tested
- Azithromycin, Metronidazole
- Keywords
- Disease Progression, Microbiota, Periodontitis/surgery, Periodontitis/therapy, Periodontitis/drug effect, Periodontitis/drug therapy, Periodontal diseases/surgery, Periodontal diseases/therapy, Periodontal pocket/surgery, Periodontal pocket/therapy, Periodontal pocket/drug therapy, Azithromycin/therapeutic use, Metronidazole/therapeutic use, Azithromycin, Metronidazole, Porphyromonas gingivalis
- Medical subject headings
- Periodontitis, Disease Progression, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinOther
azithromycin (500 mg/24h/3 days)
MetronidazoleOther
metronidazole (500 mg/8h/7 days)
| Study group | Role | What they receive |
|---|---|---|
| azythromycin + periodontal surgery. | Experimental | Periodontal surgery + Azithromycin (500 mg every 24 h for 3 days). Receives: Other: Azithromycin |
| metronidazole + periodontal surgery | Active comparator | Periodontal surgery + Metronidazole (500 mg every 8 h for 7 days). Receives: Other: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe University North Carolina 15 (UNC-15 mm)
Measured: At 6 weeks after periodontal surgery
Secondary outcomes (12)
Probing pocket depth (PPD)
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Gingival Recession (REC)
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Plaque index (PlI)
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Gingival index (GI)
Full mouth measurement of the bleeding on probing at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Furcations
Measurement of furcations with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Clinical attachment level (CAL)
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Total bacterial counts
A microbiological sample is taken with sterilized paper points from the gingival crevicular fluid and the total bacterial counts (expressed in total colony-forming units) are analyzed by culture.
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Percentage of periodontal pathogens
Determination of the percentage of the following periodontal pathogens:
- Porphyromonas gingivalis
- Tannerella forsythia
- Aggregatibacter actinomycetemcomitans
- Prevotella intermedia
- Fusobacterium nucleatum
- Eikenella corrodens
- Campylobacter rectus
- Capnocytophaga sp.
- Enterobacter sp.
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Counts of periodontal pathogens
Determination of the following periodontal pathogens: Porphyromonas gingivalis
- Tannerella forsythia
- Aggregatibacter actinomycetemcomitans
- Prevotella intermedia
- Fusobacterium nucleatum
- Eikenella corrodens
- Campylobacter rectus
- Capnocytophaga sp.
- Enterobacter sp.
Measured: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Appearance of side effects after taking antibiotic
The patient was asked if he had side effects after taking antibiotic (Yes / No)
Measured: 1 week after antibiotic consumption
Type of adverse effect after taking antibiotic
The patient was asked to write freely on a form the type of side effect suffered
Measured: 1 week after antibiotic consumption
Degree of affectation
The patient was asked to categorize the degree of affectation (mild, moderate or severe) of the secondary effect of the antibiotic if it had appeared.
Measured: 1 week after antibiotic consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study startJan 2013
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
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 Universidad Complutense de MadridThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz, Study director, University Complutense Madrid (UCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862456
- Sponsor's protocol ID
- ATB1
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Comparison of Two Different Systemic Antimicrobials (Azithromycin Versus Metronidazole) as Adjuncts to Periodontal Surgery in the Treatment of P.Gingivalis Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03862456
- Acronym / sponsor ID
- ATB1
- Conditions
- Periodontitis, Surgery
- Keywords
- Disease Progression, Microbiota, Periodontitis/surgery, Periodontitis/therapy, Periodontitis/drug effect, Periodontitis/drug therapy, Periodontal diseases/surgery, Periodontal diseases/therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 5 Mar 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.
The objective of this study is to determine whether, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis, the use of systemic antimicrobials (metronidazole versus azithromycin) as an adjunctive treatment to periodontal surgery provides clinical and microbiological benefits.
Detailed description
Design: randomized, parallel and triple blind clinical trial
Sample: Patients with periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited. 25 patients were randomized to the test group (periodontal surgery + azithromycin) and another 25 subjects to the control group (periodontal surgery + metronidazole).
Study visits:
- Examiner calibration
- Recruitment of patients. Screening. Data collection (clinical and microbiological variables).
- Phase I.
- Non-surgical periodontal treatment (2 visits).
- Reevaluation at 6 weeks. Data collection (clinical and microbiological variables). Identification of study candidate patients (Patients with probing pocket depth > 5 mm and positive to Porphyromonas gingivalis). Randomization of study groups.
- Phase II. Surgical periodontal treatment.
- Periodontal surgery sessions. In the last surgery, the antibiotic test (azithromycin) or metronidazole (control) is administered according to randomization.
- Suture removal 1 week after performing periodontal surgery. Data collection 1 week after antibiotic consumption with the last surgery (patient-centered variables on the side effects of antibiotics).
- Re-evaluation of the surgical phase at 6 weeks after the last surgery session. Data collection (clinical variables).
- Phase III. Periodontal maintenance.
- Maintenance 1 (3 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 2 (6 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 3 (9 months post surgery). Data collection (Clinical variables).
- Maintenance 4 (12 months post surgery). Data collection (Clinical and microbiological variables).
- Maintenance 5 (4 years post surgery). Data collection (Clinical and microbiological variables).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azythromycin + periodontal surgery. | Experimental | Other: AzithromycinPeriodontal surgery + Azithromycin (500 mg every 24 h for 3 days). |
| metronidazole + periodontal surgery | Active comparator | Other: MetronidazolePeriodontal surgery + Metronidazole (500 mg every 8 h for 7 days). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of periodontitis (stages III or IV) that may require periodontal surgery
- Have at least 10 teeth in function, excluding third molars.
- Present locations with probing depth (PS)> 6 mm in at least 30% of the teeth.
- Present radiographic evidence of moderate-severe bone loss in at least 30% of the dentition.
- Detection of P. gingivalis in subgingival samples taken at the screening visit as well as in the post-scaling and root planning visit and processed by culture.
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- Presenting systemic pathology and / or taking medication that may affect the periodontal situation and / or patients requiring antibiotic prophylaxis.
- Have received systemic antimicrobial treatment in the previous 6 months.
- Have received periodontal treatment in the 6 months prior to the beginning of the study.
- Patients allergic to metronidazole, or to any of the components of commercial formulations thereof (Flagyl®).
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 |
|---|---|---|
| Azithromycinazithromycin (500 mg/24h/3 days) | Other | azythromycin + periodontal surgery. |
| Metronidazolemetronidazole (500 mg/8h/7 days) | Other | metronidazole + periodontal surgery |
Primary outcome
Probing pocket depth (PPD)
Time frame: At 6 weeks after periodontal surgery
Full mouth measurement at 6 sites per tooth, with a manual periodontal probe University North Carolina 15 (UNC-15 mm)
12 secondary outcomes
Probing pocket depth (PPD)
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Gingival Recession (REC)
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Plaque index (PlI)
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Gingival index (GI)
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Furcations
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Clinical attachment level (CAL)
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I), 6 weeks after the last surgery session (Reevaluation Phase II) and during the maintenance Phase III (3, 6, 9, 12 and 48 months after periodontal surgery)
Total bacterial counts
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Percentage of periodontal pathogens
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Counts of periodontal pathogens
Time frame: At the beginning of the study, 6 weeks after scaling and root planning (Reevaluation phase I) and during the maintenance Phase III (3, 6, 12 and 48 months after periodontal surgery)
Appearance of side effects after taking antibiotic
Time frame: 1 week after antibiotic consumption
Type of adverse effect after taking antibiotic
Time frame: 1 week after antibiotic consumption
Degree of affectation
Time frame: 1 week after antibiotic consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
Mariano Sanz study director
University Complutense Madrid (UCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin and Metronidazole in people with Periodontitis and Surgery, run by Universidad Complutense de Madrid at 1 site in Spain.
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 7 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: status not confirmed, as of the sponsor's last update on 5 Mar 2019. 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 Spain. 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.
Are results available for this study?
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?
Probing pocket depth (PPD) (time frame: At 6 weeks after periodontal surgery). 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 5 Mar 2019.