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Study on Periodontal Treatment in Diabetic Patients

Primary Purpose

Diabetes, Gingivitis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Scaling and root planing plus placebo
Scaling and root planing plus azythromycin
Prophylaxis plus azythromycin
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring periodontal treatment, diabetes, glycemia, glycated hemoglobin

Eligibility Criteria

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

Inclusion Criteria:

  • Must be of legal age (≥18 years old).
  • Voluntary participation and signed informed consent.
  • Confirmed type I and II diabetes.
  • At least 10 teeth present in mouth.

Exclusion Criteria:

  • Smokers.
  • pregnant women.
  • Antibiotic consumption 3 months before inclusion.
  • HIV positive or AIDS.
  • Allergic reactions to macrolides and specifically to azythromycin.
  • Periodontal treatment 6 months before inclusion.

Sites / Locations

  • Universidad de Antioquia, School of dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Group IP1

Group IP2

Group IP3

Arm Description

Outcomes

Primary Outcome Measures

Glycated hemoglobin

Secondary Outcome Measures

Bleeding on probing
A sign of gingival inflammation
Clinical attachment level
Plaque index
Glycemia
Probing depth

Full Information

First Posted
January 5, 2011
Last Updated
May 28, 2013
Sponsor
Universidad de Antioquia
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT01271231
Brief Title
Study on Periodontal Treatment in Diabetic Patients
Official Title
Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
Collaborators
Colgate Palmolive

4. Oversight

5. Study Description

Brief Summary
Diabetes is a metabolic disorder that affects the uptake of glucose into cells. This causes a cascade of systemic alterations that may lead to kidney failure, cardiovascular complications, altered tissue healing, retinopathies and gangrene. Diabetes is also associated to increased susceptibility to infections and inflammation. It has been observed that diabetic patients suffer more often from oral infections such as periodontal disease. Periodontal disease is an infectious-inflammatory disease that leads to destruction of the surrounding tissues of the tooth. It is proposed that the mechanisms responsible for systemic complication are implicated in the development of periodontal disease. This has been evaluated in studies where diabetic patients showed increased levels of inflammatory cytokines, subgingival bacteria and limited response to treatment. Its has also been suggested that established periodontitis in the diabetic patient leads to insulin resistance due to infection and liberation of cytokines from periodontal tissues and thus worsening the diabetic condition. This study is aimed to establish the response to periodontal treatment with antibiotics and the kinetics of glucose levels in diabetic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gingivitis, Periodontitis
Keywords
periodontal treatment, diabetes, glycemia, glycated hemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group IP1
Arm Type
Placebo Comparator
Arm Title
Group IP2
Arm Type
Experimental
Arm Title
Group IP3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing plus placebo
Intervention Description
Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing plus azythromycin
Intervention Description
Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Intervention Type
Drug
Intervention Name(s)
Prophylaxis plus azythromycin
Intervention Description
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bleeding on probing
Description
A sign of gingival inflammation
Time Frame
1 year
Title
Clinical attachment level
Time Frame
1 year
Title
Plaque index
Time Frame
1 year
Title
Glycemia
Time Frame
1 year
Title
Probing depth
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be of legal age (≥18 years old). Voluntary participation and signed informed consent. Confirmed type I and II diabetes. At least 10 teeth present in mouth. Exclusion Criteria: Smokers. pregnant women. Antibiotic consumption 3 months before inclusion. HIV positive or AIDS. Allergic reactions to macrolides and specifically to azythromycin. Periodontal treatment 6 months before inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier E Botero, PhD
Organizational Affiliation
Universidad de Antioquia, School of dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fanny L Yepes, DDS
Organizational Affiliation
Universidad de Antioquia, School of dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Antioquia, School of dentistry
City
Medellin
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
17307055
Citation
Dandona P, Chaudhuri A, Ghanim H, Mohanty P. Proinflammatory effects of glucose and anti-inflammatory effect of insulin: relevance to cardiovascular disease. Am J Cardiol. 2007 Feb 19;99(4A):15B-26B. doi: 10.1016/j.amjcard.2006.11.003. Epub 2006 Dec 27.
Results Reference
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PubMed Identifier
2027060
Citation
Emrich LJ, Shlossman M, Genco RJ. Periodontal disease in non-insulin-dependent diabetes mellitus. J Periodontol. 1991 Feb;62(2):123-31. doi: 10.1902/jop.1991.62.2.123.
Results Reference
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PubMed Identifier
18380555
Citation
Novak MJ, Potter RM, Blodgett J, Ebersole JL. Periodontal disease in Hispanic Americans with type 2 diabetes. J Periodontol. 2008 Apr;79(4):629-36. doi: 10.1902/jop.2008.070442.
Results Reference
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PubMed Identifier
18316948
Citation
Mealey BL, Rose LF. Diabetes mellitus and inflammatory periodontal diseases. Curr Opin Endocrinol Diabetes Obes. 2008 Apr;15(2):135-41. doi: 10.1097/MED.0b013e3282f824b7.
Results Reference
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PubMed Identifier
18196671
Citation
Ryan ME, Carnu O, Kamer A. The influence of diabetes on the periodontal tissues. J Am Dent Assoc. 2003 Oct;134 Spec No:34S-40S. doi: 10.14219/jada.archive.2003.0370.
Results Reference
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PubMed Identifier
2645379
Citation
Sammalkorpi K. Glucose intolerance in acute infections. J Intern Med. 1989 Jan;225(1):15-9. doi: 10.1111/j.1365-2796.1989.tb00030.x.
Results Reference
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PubMed Identifier
8910827
Citation
Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, Knowler WC, Pettitt DJ. Severe periodontitis and risk for poor glycemic control in patients with non-insulin-dependent diabetes mellitus. J Periodontol. 1996 Oct;67(10 Suppl):1085-93. doi: 10.1902/jop.1996.67.10s.1085.
Results Reference
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PubMed Identifier
19322226
Citation
Garcia R. Periodontal treatment could improve glycaemic control in diabetic patients. Evid Based Dent. 2009;10(1):20-1. doi: 10.1038/sj.ebd.6400633.
Results Reference
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PubMed Identifier
19228128
Citation
Dag A, Firat ET, Arikan S, Kadiroglu AK, Kaplan A. The effect of periodontal therapy on serum TNF-alpha and HbA1c levels in type 2 diabetic patients. Aust Dent J. 2009 Mar;54(1):17-22. doi: 10.1111/j.1834-7819.2008.01083.x.
Results Reference
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PubMed Identifier
18633464
Citation
Madden TE, Herriges B, Boyd LD, Laughlin G, Chiodo G, Rosenstein D. Alterations in HbA1c following minimal or enhanced non-surgical, non-antibiotic treatment of gingivitis or mild periodontitis in type 2 diabetic patients: a pilot trial. J Contemp Dent Pract. 2008 Jul 1;9(5):9-16.
Results Reference
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PubMed Identifier
10853621
Citation
Ernst EJ, Klepser ME, Klepser TB, Nightingale CH, Hunsicker LG. Comparison of the serum and intracellular pharmacokinetics of azithromycin in healthy and diabetic volunteers. Pharmacotherapy. 2000 Jun;20(6):657-61. doi: 10.1592/phco.20.7.657.35176.
Results Reference
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Study on Periodontal Treatment in Diabetic Patients

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