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

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Generalized Aggressive Periodontitis

Treatments: Drug: amoxicillin and metronidazole; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03933501

06/0024

Details and patient eligibility

About

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).

Full 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%).

Enrollment: 48 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

FMUD + AM

Experimental group

Description:

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.

Treatment:

Drug: amoxicillin and metronidazole

FMUD

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos

SRP + AM

Experimental group

Description:

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.

Treatment:

Drug: amoxicillin and metronidazole

SRP

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos