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

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
SRP
Placebo
MTZ+AMX
Sponsored by
University of Guarulhos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Diabetes

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Guarulhos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SRP+MTZ+AMX

SRP+placebo

Arm Description

Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)

Scaling and root planing + placebo

Outcomes

Primary Outcome Measures

Changes in number of sites with probing depth (PD) ≥5 mm post-treatment

Secondary Outcome Measures

PD and clinical attachment level (CAL) changes at initially moderate sites
PD and CAL changes at initially deep sites
Changes in number of sites with PD ≥5mm
Full-mouth PD and CAL
Full-mouth percentages of sites with plaque
Full-mouth percentages of sites with marginal bleeding
Full-mouth percentages of sites with bleeding on probing
Full-mouth percentages of sites with suppuration
Full-mouth percentages of sites with PD ≥5mm
Serum levels of glycated hemoglobin (HbA1c)
Serum levels of fasting plasma glucose FPG
Levels of periodontal pathogenic bacterial species
Occurrence of adverse events

Full Information

First Posted
May 5, 2014
Last Updated
May 6, 2014
Sponsor
University of Guarulhos
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1. Study Identification

Unique Protocol Identification Number
NCT02135952
Brief Title
Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis
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 Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guarulhos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SRP+MTZ+AMX
Arm Type
Active Comparator
Arm Description
Scaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
Arm Title
SRP+placebo
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing + placebo
Intervention Type
Procedure
Intervention Name(s)
SRP
Intervention Description
SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administration of placebo for 14 days started immediately after the first session of SRP.
Intervention Type
Drug
Intervention Name(s)
MTZ+AMX
Intervention Description
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
Primary Outcome Measure Information:
Title
Changes in number of sites with probing depth (PD) ≥5 mm post-treatment
Time Frame
From baseline to 12 months
Secondary Outcome Measure Information:
Title
PD and clinical attachment level (CAL) changes at initially moderate sites
Time Frame
From baseline to 12 months and from baseline to 24 months
Title
PD and CAL changes at initially deep sites
Time Frame
From baseline to 12 months and from baseline to 24 months
Title
Changes in number of sites with PD ≥5mm
Time Frame
From baseline to 12 months and from baseline to 24 months
Title
Full-mouth PD and CAL
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Full-mouth percentages of sites with plaque
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Full-mouth percentages of sites with marginal bleeding
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Full-mouth percentages of sites with bleeding on probing
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Full-mouth percentages of sites with suppuration
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Full-mouth percentages of sites with PD ≥5mm
Time Frame
Baseline, 3, 6,12 and 24 months
Title
Serum levels of glycated hemoglobin (HbA1c)
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Serum levels of fasting plasma glucose FPG
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Levels of periodontal pathogenic bacterial species
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Occurrence of adverse events
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Poliana M Duarte, PhG
Organizational Affiliation
University of Guarulhos
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guarulhos
City
Guarulhos
State/Province
São Paulo
ZIP/Postal Code
07023-070
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22706234
Citation
Amid R, Tabeie MB, Kadkhodazadeh M, Mehdizadeh AR, Youssefi N. Local concentration of systemic amoxicillin and metronidazole in healthy and inflamed gingiva: a comparative in vivo study. Drug Metabol Drug Interact. 2012 May 10;27(2):113-8. doi: 10.1515/dmdi-2012-0003.
Results Reference
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PubMed Identifier
23627324
Citation
Borgnakke WS, Ylostalo PV, Taylor GW, Genco RJ. Effect of periodontal disease on diabetes: systematic review of epidemiologic observational evidence. J Clin Periodontol. 2013 Apr;40 Suppl 14:S135-52. doi: 10.1111/jcpe.12080.
Results Reference
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PubMed Identifier
19254119
Citation
Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Amoxicillin and metronidazole as an adjunct to full-mouth scaling and root planing of chronic periodontitis. J Periodontol. 2009 Mar;80(3):364-71. doi: 10.1902/jop.2009.080540.
Results Reference
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PubMed Identifier
20059413
Citation
Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Microbiologic testing and outcomes of full-mouth scaling and root planing with or without amoxicillin/metronidazole in chronic periodontitis. J Periodontol. 2010 Jan;81(1):15-23. doi: 10.1902/jop.2009.090390.
Results Reference
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PubMed Identifier
19728628
Citation
Feres M. Antibiotics in the treatment of periodontal diseases: microbiological basis and clinical applications. Ann R Australas Coll Dent Surg. 2008 Jun;19:37-44.
Results Reference
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PubMed Identifier
23016867
Citation
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Results Reference
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PubMed Identifier
9287060
Citation
Grossi SG, Skrepcinski FB, DeCaro T, Robertson DC, Ho AW, Dunford RG, Genco RJ. Treatment of periodontal disease in diabetics reduces glycated hemoglobin. J Periodontol. 1997 Aug;68(8):713-9. doi: 10.1902/jop.1997.68.8.713.
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PubMed Identifier
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Citation
Jimenez M, Hu FB, Marino M, Li Y, Joshipura KJ. Type 2 diabetes mellitus and 20 year incidence of periodontitis and tooth loss. Diabetes Res Clin Pract. 2012 Dec;98(3):494-500. doi: 10.1016/j.diabres.2012.09.039. Epub 2012 Oct 3.
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Citation
Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.
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Citation
Silva MP, Feres M, Sirotto TA, Soares GM, Mendes JA, Faveri M, Figueiredo LC. Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2011 Sep;38(9):828-37. doi: 10.1111/j.1600-051X.2011.01763.x. Epub 2011 Jul 15.
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Citation
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Results Reference
derived

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

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