Clinical trial NCT03933501: Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
Official title: The Use of Amoxicillin and Metronidazole in Association With Non-surgical Therapy in Aggressive Periodontitis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Aggressive Periodontitis
Keywords: Aggressive periodontitis
anti-infective agents
debridement
randomized clinical trial
ultrasonic
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%).

Eligibility criteria: 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

Primary outcomes:
measure: Change of the baseline relative clinical attachment level at 6 months
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Change of the baseline probing depth at 6 months
timeFrame: Baseline, 3 months and 6 months
measure: Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 6 months
timeFrame: Baseline, 3 months and 6 months
measure: Change in the microbial composition at 6 months
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Taiete T, Monteiro MF, Casati MZ, do Vale HF, Ambosano GMB, Nociti FH, Sallum EA, Casarin RCV. Local IL-10 level as a predictive factor in generalized aggressive periodontitis treatment response. Scand J Immunol. 2019 Dec;90(6):e12816. doi: 10.1111/sji.12816. Epub 2019 Oct 3.