A Phase 4 interventional study of amoxicillin and metronidazole and Placebos in Generalized Aggressive Periodontitis, sponsored by University of Campinas, Brazil. Completed. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by University of Campinas, Brazil · Phase 4, Interventional, and Treatment
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).
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%).
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 48 is close to the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days.
Drug: amoxicillin and metronidazole
One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
Drug: Placebos
Four sessions (1/week) of scaling and root planning, plus 375 mg amoxicillin and 250 mg metronidazole (AM) prescribed on the last session of treatment and taken every 8 hours for 7 days.
Drug: amoxicillin and metronidazole
Four sessions (1/week) of scaling and root planning, plus two distinct placebo pills prescribed on the last session of treatment and taken every 8 hours for 7 days.
Drug: Placebos
375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
Change of the baseline relative clinical attachment level at 6 months
distance from the bottom of the pocket to the stent margin.
Time frame: Baseline, 3 months and 6 months
Change of the baseline probing depth at 6 months
Distance from the bottom of pocket to gingival margin;
Time frame: Baseline, 3 months and 6 months
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
Concentration of IL-1β, IL-10 released in gingival crevicular fluid
Time frame: Baseline, 3 months and 6 months
Change in the microbial composition at 6 months
Concentration of bacteria in the subgingival biofilm
Time frame: Baseline, 3 months and 6 months
No study locations are listed for this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil