NCT03933501

Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is designed as a parallel, masked, randomized, placebo-controlled clinical trial to assess the clinical, microbiological, and immunological outcomes of scaling and root planning (SRP) or full-mouth ultrasonic debridement (FMUD) with AM (Amoxicillin + Metronidazole) for the treatment of Generalized Aggressive Periodontitis (GAgP).

Detailed description

Forty eight GAgP patients were divided into 4 groups: the SRP group (n = 12), which received SRP plus placebo, and the SRP+AM group (n = 12), which received SRP and 375mg amoxicillin plus 250 mg metronidazole for 7 days, the FMUD group (n = 12), which received FMUD plus placebo, and the FMUD+AM group (n = 12), which received FMUD and 375mg amoxicillin plus 250 mg metronidazole for 7 days. The following clinical outcomes were tested: plaque and bleeding on probing indices, pocket probing depth (PD), relative gingival margin position (GMP), and relative clinical attachment level (CAL). The total amount of Porphyromonas gingivalis (Pg), Aggregatibacter actinomycetemcomitans (Aa), Tannerella forsythia (Tf), and gingival crevicular fluid (GCF) concentration of interleukin (IL)-10 and IL-1b were also determined. All clinical, microbiological, and immunological parameters were assessed at baseline and at 3 and 6 months post-therapy. The ANOVA/Tukey test was used for statistical analysis (a = 5%).

Conditions

• Generalized Aggressive Periodontitis

Interventions

Type	Name	Description
DRUG	amoxicillin and metronidazole	375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
DRUG	Placebos	Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2018-12-01
• First posted: 2019-05-01
• Last updated: 2019-05-13