Study on Periodontal Treatment in Diabetic Patients

Diabetes Clinical Trial

Official title:

Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271231
• Other study ID #: 020-2009
• Status: Completed
• Phase: N/A
• First received: January 5, 2011
• Last updated: May 28, 2013
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: May 2013
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Gingivitis
• Periodontitis

Intervention

Drug:
• Scaling and root planing plus placebo
Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
• Scaling and root planing plus azythromycin
Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
• Prophylaxis plus azythromycin
Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.

Locations

Country	Name	City	State
Colombia	Universidad de Antioquia, School of dentistry	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Colgate Palmolive

Country where clinical trial is conducted

Colombia, 

References & Publications (11)

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

Outcome

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