Amoxicillin and Metronidazole During Periodontal Treatment (MOMENT)

January 8, 2020 updated by: Belén Retamal-Valdes

Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The combination of systemic metronidazole (MTZ) and amoxicillin (AMX) to scaling and root planing (SRP) has shown to be a promising periodontal treatment. However, some essential issues associated with the use of these antibiotics remain to be established. Although these agents are often prescribed after the healing phase of the SRP procedure, there is biological plausibility to support its use in conjunction with the mechanical treatment. However, to date, no placebo controlled randomized clinical trial (RCT) has directly compared these two protocols. Therefore, the aim of this multicentric RCT is to compare the clinical, microbiological and immunological effects of adjunctive systemic MTZ+AMX administered in different phases of the treatment of generalized chronic periodontitis (GChP). 180 subjects with GChP will be randomly assigned into three groups (n=60/group) that will receive SRP-only (control group) or in combination with 400 mg MTZ+500 mg AMX beginning at the first SRP session (group test 1) or after 3 months of its completion (group test 2). All volunteers will receive clinical and microbiological evaluation at baseline, 3, 6 and 12 months, and immunological assessment (levels of 20 chemokines) at baseline and 12 months post-therapy. Nine subgingival biofilm samples will be collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical, microbiological and immunological parameters among groups and over time will be evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes will be performed using adjustments for multiple comparisons. Statistical significance will be set at 5%.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-000
        • University of Sao Paulo
    • São Paulo
      • Guarulhos, São Paulo, Brazil, 07023-070
        • University of Guarulhos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥35 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 6 months;
  • antibiotic therapy in the previous 6 months;
  • long-term intake of anti-inflammatory medications;
  • need for antibiotic pre-medication for routine dental therapy;
  • use of orthodontic appliances;
  • extensive dental prosthetic rehabilitation;
  • allergy to metronidazole and/or amoxicillin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Placebos healing phase TID for 14 days.
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.
Other Names:
  • SRP
Drug: Placebos active phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Other Names:
  • P 1
Drug: Placebos healing phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
Other Names:
  • P 2
Active Comparator: Active phase
Scaling and root planing + Metronidazole active phase (400 mg/thrice a day,TID) + Amoxicillin active phase (500 mg/ TID) for 14 days and Placebos healing phase TID for 14 days.
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.
Other Names:
  • SRP
Drug: Placebos healing phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
Other Names:
  • P 2
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).
Other Names:
  • MTZ 1
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).
Other Names:
  • AMX 1
Active Comparator: Healing phase
Scaling and root planing + Placebos active phase thrice a day (TID) for 14 days and Metronidazole healing phase (400 mg/TID) + Amoxicillin healing phase (500 mg/TID) for 14 days.
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.
Other Names:
  • SRP
Drug: Placebos active phase
Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
Other Names:
  • P 1
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).
Other Names:
  • MTZ 2
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).
Other Names:
  • AMX 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of sites with PD ≥ 5 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 6 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Number of sites with PD ≥ 7 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 5 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 6 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Reduction in the number of sites with PD ≥ 7 mm.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Mean PD changes in sites with initial PD between 4-6 mm
Time Frame: Baseline - 12 months.
Baseline - 12 months.
Mean PD changes in sites with initial PD ≥ 7 mm.
Time Frame: Baseline - 12 months.
Baseline - 12 months.
Mean CAL changes in sites with initial CAL between 4-6 mm
Time Frame: Baseline - 12 months.
Baseline - 12 months.
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Time Frame: Baseline - 12 months.
Baseline - 12 months.
Full-mouth PD.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Full-mouth clinical attachment level.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Percentage of sites with bleeding on probing.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Percentage of sites with plaque accumulation
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Percentage of sites with marginal bleeding.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Occurrence of headache obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Occurrence of vomiting obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Occurrence of metallic taste obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Occurrence of irritability obtained through a questionnaire of adverse effects.
Time Frame: 14 days after taking antibiotic.
14 days after taking antibiotic.
Proportions of periodontal pathogenic bacterial species.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Counts of periodontal pathogenic bacterial species.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.
Counts of chemokines in the crevicular gingival fluid.
Time Frame: Baseline and 12 months.
Baseline and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belén Retamal-Valdes

Investigators

  • Study Chair: Magda Feres, Professor, University of Guarulhos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 32465714.4.1001.5506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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