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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

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
    • 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

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
Intervention / Treatment
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

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

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

Belén Retamal-Valdes

Investigators

  • 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)

January 31, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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