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Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

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ClinicalTrials.gov Identifier: NCT02135952
Recruitment Status : Unknown
Verified May 2014 by Poliana Mendes Duarte, University of Guarulhos.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Poliana Mendes Duarte, University of Guarulhos

Brief Summary:
Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: SRP Other: Placebo Drug: MTZ+AMX Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metronidazole and Amoxicillin as Adjuncts to Scaling and Root Planing for the Treatment of Type 2 Diabetic Subjects With Periodontitis: a Randomized Placebo-controlled Clinical Trial
Study Start Date : September 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014


Arm Intervention/treatment
Active Comparator: SRP+MTZ+AMX
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
Procedure: SRP
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.

Drug: MTZ+AMX
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.

Placebo Comparator: SRP+placebo
Scaling and root planing + placebo
Procedure: SRP
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.

Other: Placebo
Administration of placebo for 14 days started immediately after the first session of SRP.




Primary Outcome Measures :
  1. Changes in number of sites with probing depth (PD) ≥5 mm post-treatment [ Time Frame: From baseline to 12 months ]

Secondary Outcome Measures :
  1. PD and clinical attachment level (CAL) changes at initially moderate sites [ Time Frame: From baseline to 12 months and from baseline to 24 months ]
  2. PD and CAL changes at initially deep sites [ Time Frame: From baseline to 12 months and from baseline to 24 months ]
  3. Changes in number of sites with PD ≥5mm [ Time Frame: From baseline to 12 months and from baseline to 24 months ]
  4. Full-mouth PD and CAL [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  5. Full-mouth percentages of sites with plaque [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  6. Full-mouth percentages of sites with marginal bleeding [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  7. Full-mouth percentages of sites with bleeding on probing [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  8. Full-mouth percentages of sites with suppuration [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  9. Full-mouth percentages of sites with PD ≥5mm [ Time Frame: Baseline, 3, 6,12 and 24 months ]
  10. Serum levels of glycated hemoglobin (HbA1c) [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  11. Serum levels of fasting plasma glucose FPG [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  12. Levels of periodontal pathogenic bacterial species [ Time Frame: Baseline, 3, 6, 12 and 24 months ]
  13. Occurrence of adverse events [ Time Frame: 14 days ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 35 years of age
  • Diagnosis of type 2 DM for ≥ 5 years
  • DM treatment with diet and insulin supplementation or oral hypoglycemic agents
  • Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11%
  • At least 15 teeth
  • More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm
  • Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline.

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Current smoking
  • Smoking within the past 5 years
  • Scaling and root planing (SRP) in the previous 12 months
  • Antimicrobial therapies during the previous 6 months
  • Medical conditions requiring prophylactic antibiotic coverage
  • Continuous use of mouthrinses containing antimicrobials in the preceding 3 months
  • Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis)
  • Long-term administration of anti-inflammatory
  • Long-term administration of immunosuppressive medications
  • Allergy to metronidazole and/or amoxicillin
  • Presence of periapical pathology
  • Use of orthodontic appliances
  • Presence of extensive prosthetic rehabilitation
  • Major complications of DM (i.e. cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy)

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): NCT02135952


Locations
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Brazil
University of Guarulhos
Guarulhos, São Paulo, Brazil, 07023-070
Sponsors and Collaborators
University of Guarulhos
Investigators
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Principal Investigator: Poliana M Duarte, PhG University of Guarulhos

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poliana Mendes Duarte, PhD, University of Guarulhos
ClinicalTrials.gov Identifier: NCT02135952     History of Changes
Other Study ID Numbers: SISNEP/697
2013/01072-5 ( Other Grant/Funding Number: FAPESP - 2013/01072-5 )
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by Poliana Mendes Duarte, University of Guarulhos:
Periodontitis
Diabetes

Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents