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

University of Campinas, Brazil48 enrolled

Overview

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%).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Generalized Aggressive Periodontitis

Interventions

amoxicillin and metronidazoleDRUG

375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.

PlacebosDRUG

Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of GAgP; * presence of 20 teeth; * presence of teeth presenting PD\>5 mm with bleeding on probing (BOP) and 2 teeth with PD\>7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them); * good general health; * \<35 years of age. Exclusion Criteria: * were pregnant or lactating; * were suffering from any other systemic diseases (e.g., cardiovascular, diabetes); * received antimicrobials in the previous 3 months; * were taking long-term anti-inflammatory drugs; * received a course of periodontal treatment within the last 6 months; * smoked

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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