NCT03880448

Metronidazole vs Placebo as Adjuncts to Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

Clinical and Microbiological Evaluation of Metronidazole as a Systemic Antimicrobial Adjunct to Periodontal Surgery in the Treatment of Patients With Periodontitis Positive to Porphyromonas Gingivalis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine whether the use of a systemic antimicrobial (metronidazole) as an adjunct to periodontal surgery provides additional clinical and microbiological beneficial effects compared to periodontal surgery alone plus a placebo, in patients with non treated periodontitis (stage III and IV) positive to Porphyromonas gingivalis.

Detailed description

Design: pilot, randomized, parallel, placebo controlled and triple blind clinical trial. Sample: Patients with generalized severe chronic periodontitis (stages III and IV) and positive to Porphyromonas gingivalis who potentially need periodontal surgery were recruited from those who attended the postgraduate program in periodontics at the Complutense University in Madrid. Patients were randomly assigned to the test group (periodontal surgery + metronidazole) or control group (periodontal surgery + placebo). Study visits: * Examiner calibration * Recruitment of patients. Screening. Data collection (clinical and microbiological variables) * Phase I * Non surgical periodontal therapy (2 visits) performed by second year students. * Reevaluation at 6 weeks. Data collection (clinical and microbiological variables). Identification of study participants (patients with probing pocket depth \> 5mm in ≥ 2 teeth per sextant or those presenting multiple sites with probing pocket depth ≥ 5mm and bleeding on probing in ≥ one mouth quadrant and positive to Porphyromonas gingivalis. The need of the surgical procedure was supervised in every case by more than one experienced periodontist (clinical teachers). Finally patients were randomly assigned to their study groups. * Phase II. Surgical Periodontal Therapy * Periodontal surgery sessions performed by second year students. In the last surgery the patient received a recipient containing the pills (metronidazole or placebo according to randomization) and the instructions for use. * Suture removal 1 week after the surgery. Data collection 1 week after antibiotic consumption after the last surgery (patient-centered variables on the side effects of antibiotics). Pills recipients were collected in order to evaluate patient compliance. An individual not involved in the study protocol was in charge of doing the data and recipient collection. * Phase III. Periodontal Maintenance. * Maintenance 1(3 months postsurgery). Data collection (clinical and microbiological variables) * Maintenance 2 (6 months postsurgery). Data collection (clinical and microbiological variables) * Maintenance 3 (9 months postsurgery). * Maintenance 4 (12 months postsurgery). Data collection (clinical and microbiological variables) Security protocol: Any patient exhibiting worsening in periodontal clinical parameters during the maintenance phase were excluded from the study and inestable sites were re-treated. Inestable sites were considered those exhibiting clinical attachment loss \> 2mm between two consecutive visits (Haffajee et al. 1983) after the treatment.

Conditions

• Periodontitis
• Surgery

Interventions

Type	Name	Description
DRUG	Metronidazole	Metronidazole 500mg/8h/7days
DRUG	Placebo	Cornstarch 500mg/8h/7days
PROCEDURE	periodontal surgery	periodontal surgery

Timeline

• Start date: 2012-09-19
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2019-03-19
• Last updated: 2019-03-20

Locations

1 site across 1 country: Spain