Amoxicillin and Metronidazole During Periodontal Treatment

Summary

The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.

Conditions

• Chronic Periodontitis

Interventions

PROCEDURE

Scaling and root planing

SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.

DRUG

Metronidazole active phase

Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).

DRUG

Metronidazole healing phase

Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).

DRUG

Amoxicillin active phase

Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).

DRUG

Amoxicillin healing phase

Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).

DRUG

Placebos active phase

Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).

DRUG

Placebos healing phase

Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).

Sponsors & Collaborators

• Belén Retamal-Valdes

  lead OTHER

Principal Investigators

• Magda Feres, Professor · University of Guarulhos

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2019-12-31

Completion

2020-12-31

Countries

• Brazil

Study Locations