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

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ClinicalTrials.gov Identifier: NCT02735395
Recruitment Status : Unknown
Verified May 2017 by Belén Retamal-Valdes, University of Guarulhos.
Recruitment status was:  Active, not recruiting
First Posted : April 12, 2016
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Belén Retamal-Valdes, University of Guarulhos

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Scaling and root planing (SRP) Drug: Metronidazole 250 (7 days) Drug: Metronidazole 400 (7 days) Drug: Metronidazole 250 (14 days) Drug: Metronidazole 400 (14 days) Drug: Amoxicillin Other: Placebo 250 (7 days) Other: Placebo 400 (7 days) Other: Placebo 400 (14 days) Other: Placebo 500 Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial
Study Start Date : July 2011
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Placebo Comparator: Control
Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
Procedure: Scaling and root planing (SRP)
SRP 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: Placebo 400 (14 days)
Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

Other: Placebo 500
Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

Active Comparator: MTZ 250 (7 days)
SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
Procedure: Scaling and root planing (SRP)
SRP 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 250 (7 days)
Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.

Drug: Amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.

Other: Placebo 250 (7 days)
Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.

Active Comparator: MTZ 400 (7 days)
SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
Procedure: Scaling and root planing (SRP)
SRP 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 400 (7 days)
Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.

Drug: Amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.

Other: Placebo 400 (7 days)
Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.

Active Comparator: MTZ 250 (14 days)
SRP +MTZ (250mg/TID) + AMX for 14 days
Procedure: Scaling and root planing (SRP)
SRP 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 250 (14 days)
Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

Drug: Amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.

Active Comparator: MTZ 400 (14 days)
SRP +MTZ (400mg/TID) + AMX for 14 days
Procedure: Scaling and root planing (SRP)
SRP 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 400 (14 days)
Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

Drug: Amoxicillin
Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.




Primary Outcome Measures :
  1. Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of sites with PD ≥ 5 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  2. Number of sites with PD ≥ 6 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  3. Number of sites with PD ≥ 7 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  4. Reduction in the number of sites with PD ≥ 5 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  5. Reduction in the number of sites with PD ≥ 6 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  6. Reduction in the number of sites with PD ≥ 7 mm [ Time Frame: Baseline, 3, 6 and 12 months ]
  7. Full-mouth PD [ Time Frame: Baseline, 3, 6 and 12 months ]
  8. Full-mouth clinical attachment level [ Time Frame: Baseline, 3, 6 and 12 months ]
  9. Percentage of sites with bleeding on probing [ Time Frame: Baseline, 3, 6 and 12 months ]
  10. Percentage of sites with plaque accumulation [ Time Frame: Baseline, 3, 6 and 12 months ]
  11. Percentage of sites with marginal bleeding [ Time Frame: Baseline, 3, 6 and 12 months ]
  12. Occurrence of headache obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  13. Occurrence of vomiting obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  14. Occurrence of diarrhea obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  15. Occurrence of metallic taste obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  16. Occurrence of nausea obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  17. Occurrence of irritability obtained through a questionnaire of adverse effects [ Time Frame: 14 days after the beginning of treatments ]
  18. Proportions of periodontal pathogenic bacterial species [ Time Frame: Baseline, 3, 6 and 12 months ]
  19. Counts of periodontal pathogenic bacterial species [ Time Frame: Baseline, 3, 6 and 12 months ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735395


Locations
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Brazil
Guarulhos University
Guarulhos, São Paulo, Brazil, 07023-070
Sponsors and Collaborators
University of Guarulhos
Investigators
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Study Chair: Magda Feres, Professor Guarulhos University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Belén Retamal-Valdes, DDS, MSc, PhD Student, University of Guarulhos
ClinicalTrials.gov Identifier: NCT02735395     History of Changes
Other Study ID Numbers: SISNEP/513
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Keywords provided by Belén Retamal-Valdes, University of Guarulhos:
Periodontal Diseases
Metronidazole
Amoxicillin
Chronic periodontitis
Root Planing
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents