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CompletedNCT01271231Updated May 29, 2013

Study on Periodontal Treatment in Diabetic Patients

An interventional study of Scaling and root planing plus placebo and Scaling and root planing plus azythromycin in Diabetes, Gingivitis and Periodontitis, sponsored by Universidad de Antioquia. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Universidad de Antioquia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Gingivitis
  • Periodontitis

Keywords

  • periodontal treatment, diabetes, glycemia, glycated hemoglobin
03

In context

Gingivitis

591 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 90 is above the median of 63 across 479 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Universidad de Antioquia is the lead sponsor of 79 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Group IP1

    Drug: Scaling and root planing plus placebo

  • Experimental
    Group IP2

    Drug: Scaling and root planing plus azythromycin

  • Active comparator
    Group IP3

    Drug: Prophylaxis plus azythromycin

Interventions

  • DrugScaling 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

  • DrugScaling 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.

  • DrugProphylaxis plus azythromycin

    Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.

06

What researchers measure

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 1 year

Secondary outcomes

  1. Bleeding on probing

    A sign of gingival inflammation

    Time frame: 1 year

  2. Clinical attachment level

    Time frame: 1 year

  3. Plaque index

    Time frame: 1 year

  4. Glycemia

    Time frame: 1 year

  5. Probing depth

    Time frame: 1 year

07

Study locations

1 site
  • Universidad de Antioquia, School of dentistry
    Medellin, Antioquia, Colombia
08

References and documents

Publications

  • 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. PubMed 17307055 ↗
  • 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. PubMed 2027060 ↗
  • 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. PubMed 18380555 ↗
  • 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. PubMed 18316948 ↗
  • 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. PubMed 18196671 ↗
  • 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. PubMed 2645379 ↗
  • 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. PubMed 8910827 ↗
  • 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. PubMed 19322226 ↗
  • 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. PubMed 19228128 ↗
  • 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. PubMed 18633464 ↗
  • 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. PubMed 10853621 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01271231
Lead sponsor
Universidad de Antioquia
Collaborators
Colgate Palmolive
Responsible party
Javier Enrique Botero (Assistant Professor, Universidad de Antioquia) — Principal investigator
First posted
Jan 6, 2011
Start date
Apr 2010
Primary completion
Jul 2012
Completion
Oct 2012
Last update
May 29, 2013

Study contacts

Javier E Botero, PhD
study director · Universidad de Antioquia, School of dentistry
Fanny L Yepes, DDS
principal investigator · Universidad de Antioquia, School of dentistry
View the source record on ClinicalTrials.gov ↗

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