Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis

University of Guarulhos

Status and phase: Unknown; Phase 4

Conditions: Chronic Periodontitis

Treatments: Drug: Metronidazole 250 (7 days); Drug: Metronidazole 250 (14 days); Other: Placebo 500; Procedure: Scaling and root planing (SRP); Drug: Amoxicillin; Other: Placebo 400 (14 days); Other: Placebo 400 (7 days); Drug: Metronidazole 400 (7 days); Other: Placebo 250 (7 days); Drug: Metronidazole 400 (14 days)

Study type: Interventional

Funder types: Other

Identifiers

NCT02735395

SISNEP/513

Details and patient eligibility

About

The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).

Full description

Randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (MTZ) and amoxicillin (AMX) significantly improves the benefits of the SRP in the treatment of subjects with periodontitis. However, the optimal dosage and interval of administration of these antibiotics are still unclear. Therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of MTZ and AMX as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). One hundred ten subjects will be randomly assigned to receive SRP plus placebo, or SRP combined with 250 mg or 400 mg of MTZ, plus AMX (500 mg) TID, for either 7 or 14 days. Subjects will be clinically and microbiologically monitored up to 1 year post-therapy.

Enrollment: 110 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥30 years of age;
• at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
• a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical * attachment level (CAL) ≥5 mm;
• at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).

Exclusion criteria

• pregnancy
• breastfeeding
• current smoking and former smoking within the past 5 years;
• systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
• scaling and root planing an in the previous 12 months;
• antibiotic therapy in the previous 6 months;
• long-term intake of anti-inflammatory medications;
• need for antibiotic pre-medication for routine dental therapy;
• allergy to metronidazole and/or amoxicillin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 5 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)

Treatment:

Other: Placebo 500

Procedure: Scaling and root planing (SRP)

Other: Placebo 400 (14 days)

MTZ 250 (7 days)

Active Comparator group

Description:

SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days

Treatment:

Other: Placebo 250 (7 days)

Drug: Metronidazole 250 (7 days)

Procedure: Scaling and root planing (SRP)

Drug: Amoxicillin

MTZ 400 (7 days)

Active Comparator group

Description:

SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days

Treatment:

Drug: Metronidazole 400 (7 days)

Procedure: Scaling and root planing (SRP)

Other: Placebo 400 (7 days)

Drug: Amoxicillin

MTZ 250 (14 days)

Active Comparator group

Description:

SRP +MTZ (250mg/TID) + AMX for 14 days

Treatment:

Drug: Metronidazole 250 (14 days)

Procedure: Scaling and root planing (SRP)

Drug: Amoxicillin

MTZ 400 (14 days)

Active Comparator group

Description:

SRP +MTZ (400mg/TID) + AMX for 14 days

Treatment:

Drug: Metronidazole 400 (14 days)

Procedure: Scaling and root planing (SRP)

Drug: Amoxicillin