Amoxicillin and Metronidazole During or After the Periodontal Treatment

December 11, 2023 updated by: Belén Retamal-Valdes

Timing of Administration of Systemic Antibiotics Associated With Scaling and Root Planing in the Treatment of Periodontitis: Clinical and Microbiological Evaluation

This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scaling and root planing (SRP) is the most used periodontal therapy for periodontal treatment. Despite leading, in most cases, to an improvement in periodontal clinical parameters, SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health, especially in cases of more advanced and generalized diseases. Thus, other therapies supporting SRP, such as systemic antibiotics, have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy. Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics, especially the association of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of severe periodontitis. However, some essential issues associated with the use of these antibiotics remain to be established. Therefore, the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Seventy-two subjects with severe periodontitis were selected and randomized into two groups (n = 36 / group) - Test 1 (T1): SRP in 14 days, associated with the concomitant use of AMX (500mg, 3x / day) and MTZ (400mg 3x / day) for 14 days; and Test 2 (T2): SRP in 14 days, associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days. All volunteers received clinical and microbiological evaluation at baseline, 3, 6 and 12 months post-SRP. Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes were performed using adjustments for multiple comparisons. Statistical significance was set at 5%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Sao Paulo
      • Guarulhos, Sao 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 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 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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test 1
Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session
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 after SRP
Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session.
Drug: Metronidazole during SRP
Metronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session.
Drug: Amoxicillin during SRP
Amoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session.
Experimental: Test 2
Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 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 during SRP
Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session.
Drug: Metronidazole after SRP
Metronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session.
Drug: Amoxicillin after SRP
Amoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 ≥ 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 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.
Mean CAL changes in sites with initial CAL between 4-6 mm ,
Time Frame: Baseline - 12 months.
Baseline - 12 months.
Percentage of sites with plaque accumulation.
Time Frame: Baseline, 3, 6 and 12 months.
Baseline, 3, 6 and 12 months.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Belén Retamal-Valdes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marcelo Faveri, 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SISNEP/726_Jan31_2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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