Diabetes Clinical Trial
Official title:
Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients
Verified date | May 2013 |
Source | Universidad de Antioquia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad de Antioquia, School of dentistry | Medellin | Antioquia |
Lead Sponsor | Collaborator |
---|---|
Universidad de Antioquia | Colgate Palmolive |
Colombia,
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. — View 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. Epub 2006 Dec 27. Review. — View Citation
Emrich LJ, Shlossman M, Genco RJ. Periodontal disease in non-insulin-dependent diabetes mellitus. J Periodontol. 1991 Feb;62(2):123-31. — View 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. — View 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. — View 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. — View 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. Review. — View 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 . — View 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. Review. — View Citation
Sammalkorpi K. Glucose intolerance in acute infections. J Intern Med. 1989 Jan;225(1):15-9. — View 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glycated hemoglobin | 1 year | No | |
Secondary | Bleeding on probing | A sign of gingival inflammation | 1 year | No |
Secondary | Clinical attachment level | 1 year | No | |
Secondary | Plaque index | 1 year | No | |
Secondary | Glycemia | 1 year | No | |
Secondary | Probing depth | 1 year | No |
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