Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

Not Applicable

• Conditions: Periodontitis; Surgery
• Interventions: Other: Azithromycin; Other: Metronidazole

• Registration Number: NCT03862456
• Lead Sponsor: Universidad Complutense de Madrid

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).

Study Timeline

• Study Start: 2013-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-01
• Last Update Submitted: 2019-03-01
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
azythromycin + periodontal surgery.	Azithromycin	Periodontal surgery + Azithromycin (500 mg every 24 h for 3 days).
metronidazole + periodontal surgery	Metronidazole	Periodontal surgery + Metronidazole (500 mg every 8 h for 7 days).

Primary Outcome Measures

Name	Time	Method
Probing pocket depth (PPD)	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)

Secondary Outcome Measures

Name	Time	Method
Gingival Recession (REC)	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)	Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Furcations	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)	Measurement of furcations with a manual periodontal probe UNC-15 mm
Percentage of periodontal pathogens	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)	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.
Probing pocket depth (PPD)	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)	Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Gingival index (GI)	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)	Full mouth measurement of the bleeding on probing at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Total bacterial counts	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)	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.
Plaque index (PlI)	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)	Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Clinical attachment level (CAL)	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)	Full mouth measurement at 6 sites per tooth, with a manual periodontal probe UNC-15 mm
Counts of periodontal pathogens	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)	Determination of the following periodontal pathogens: Porphyromonas gingivalis; * Tannerella forsythia; * Aggregatibacter actinomycetemcomitans; * Prevotella intermedia; * Fusobacterium nucleatum; * Eikenella corrodens; * Campylobacter rectus; * Capnocytophaga sp.; * Enterobacter sp.
Appearance of side effects after taking antibiotic	1 week after antibiotic consumption	The patient was asked if he had side effects after taking antibiotic (Yes / No)
Type of adverse effect after taking antibiotic	1 week after antibiotic consumption	The patient was asked to write freely on a form the type of side effect suffered
Degree of affectation	1 week after antibiotic consumption	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Univesity Complutense, Madrid; 🇪🇸 Madrid, Spain