Surgery Clinical Trial - Metronidazole vs Azithromycin in Periodontal

Status Active, not recruiting

Clinical 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 benefits.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03862456
Study type	Interventional
Source	Universidad Complutense de Madrid
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 2013
Completion date	July 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms