Clinical trial NCT03862456: Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Surgery
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
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: At 6 weeks after periodontal surgery
Secondary outcomes:
measure: Probing pocket depth (PPD)
timeFrame: 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)
measure: Gingival Recession (REC)
timeFrame: 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)
measure: Plaque index (PlI)
timeFrame: 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)
measure: Gingival index (GI)
timeFrame: 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)
measure: Furcations
timeFrame: 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)
measure: Clinical attachment level (CAL)
timeFrame: 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)
measure: Total bacterial counts
timeFrame: 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)
measure: Percentage of periodontal pathogens
timeFrame: 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)
measure: Counts of periodontal pathogens
timeFrame: 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)
measure: Appearance of side effects after taking antibiotic
timeFrame: 1 week after antibiotic consumption
measure: Type of adverse effect after taking antibiotic
timeFrame: 1 week after antibiotic consumption
measure: Degree of affectation
timeFrame: 1 week after antibiotic consumption
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Dentistry, Univesity Complutense, Madrid
Study officials:
affiliation: University Complutense Madrid (UCM)
name: Mariano Sanz
role: STUDY_DIRECTOR
References: