Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-30 @ 4:20 PM
Study NCT ID:
NCT03862456
Status:
UNKNOWN
Last Update Posted:
2019-03-05
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metronidazole vs Azithromycin in Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: