DiabetesNCT01271231

Study on Periodontal Treatment in Diabetic Patients

A study testing Scaling and root planing plus azythromycin and Prophylaxis plus azythromycin in people with Diabetes and Gingivitis, run by Universidad de Antioquia at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Gingivitis, Periodontitis
What is being tested?: Scaling and root planing plus azythromycin and Prophylaxis plus azythromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteColombia
Study dates: Apr 2010to Oct 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Universidad de Antioquia, School of dentistry
Medellín, Antioquia

Other trials in Colombia

About this study

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

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.

Conditions: Diabetes, Gingivitis, Periodontitis
Being tested: Scaling and root planing plus placebo, Scaling and root planing plus azythromycin, Prophylaxis plus azythromycin
Keywords: periodontal treatment, diabetes, glycemia, glycated hemoglobin
Medical subject headings: Diabetes Mellitus, Gingivitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01271231
Study group	Role	What they receive
Group IP1	Placebo comparator	Not described Receives: Drug: Scaling and root planing plus placebo
Group IP2	Experimental	Not described Receives: Drug: Scaling and root planing plus azythromycin
Group IP3	Active comparator	Not described Receives: Drug: Prophylaxis plus azythromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycated hemoglobin
Measured: 1 year

Secondary outcomes (5)

Bleeding on probing
A sign of gingival inflammation
Measured: 1 year
Clinical attachment level
Measured: 1 year
Plaque index
Measured: 1 year
Glycemia
Measured: 1 year
Probing depth
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2012

First posted6 Jan 2011 (estimated)
Study startApr 2010
Primary completionJul 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01271231
Sponsor's protocol ID: 020-2009
Status last verified: May 2013
First submitted: 5 Jan 2011
Last updated: 29 May 2013
Results posted: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Periodontal Treatment on Clinical Parameters and Glucose Metabolism in Diabetic Patients
ClinicalTrials.gov ID: NCT01271231
Acronym / sponsor ID: 020-2009
Conditions: Diabetes, Gingivitis, Periodontitis
Keywords: periodontal treatment, diabetes, glycemia, glycated hemoglobin
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Universidad de AntioquiaUniversity, hospital or other
Collaborators: Colgate Palmolive
Study start: Apr 2010
Primary completion: Jul 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 6 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is aimed to establish the response to periodontal treatment with antibiotics and the kinetics of glucose levels in diabetic patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group IP1	Placebo comparator	Drug: Scaling and root planing plus placebo
Group IP2	Experimental	Drug: Scaling and root planing plus azythromycin
Group IP3	Active comparator	Drug: Prophylaxis plus azythromycin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scaling and root planing plus placeboSingle session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days	Drug	Group IP1
Scaling and root planing plus azythromycinSingle session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.	Drug	Group IP2
Prophylaxis plus azythromycinDental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.	Drug	Group IP3

Primary outcome

Glycated hemoglobin
Time frame: 1 year

5 secondary outcomes

Bleeding on probing
Time frame: 1 year
Clinical attachment level
Time frame: 1 year
Plaque index
Time frame: 1 year
Glycemia
Time frame: 1 year
Probing depth
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
Background: PubMed 17307055Dandona 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.
Background: PubMed 2027060Emrich 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.
Background: PubMed 18380555Novak 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.
Background: PubMed 18316948Mealey 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.
Background: PubMed 18196671Ryan 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.
Background: PubMed 2645379Sammalkorpi K. Glucose intolerance in acute infections. J Intern Med. 1989 Jan;225(1):15-9. doi: 10.1111/j.1365-2796.1989.tb00030.x.
Background: PubMed 8910827Taylor 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.
Background: PubMed 19322226Garcia R. Periodontal treatment could improve glycaemic control in diabetic patients. Evid Based Dent. 2009;10(1):20-1. doi: 10.1038/sj.ebd.6400633.
Background: PubMed 19228128Dag 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.
Background: PubMed 18633464Madden 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.
Background: PubMed 10853621Ernst 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.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier E Botero, PhD study director

Universidad de Antioquia, School of dentistry

Fanny L Yepes, DDS principal investigator

Universidad de Antioquia, School of dentistry

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scaling and root planing plus azythromycin and Prophylaxis plus azythromycin in people with Diabetes and Gingivitis, run by Universidad de Antioquia at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated hemoglobin (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01271231, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.