NCT01094639

Brief Summary

The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. The study investigates what happens to inflammatory markers in blood and saliva after you are treated for gum disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

5.9 years

First QC Date

March 23, 2010

Last Update Submit

October 24, 2016

Conditions

PeriodontitisChronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels

    IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.

    2 months

Secondary Outcomes (1)

  • Changes in periodontal (gum) clinical presentation and status

    2 months

Study Arms (2)

Supragingival prophylaxis

PLACEBO COMPARATOR

Plaque removal

Procedure: Supragingival Prophylaxis

Scaling root planing

ACTIVE COMPARATOR

SRP+oral hygiene

Procedure: Scaling root planing

Interventions

Scaling root planingPROCEDURE

Deep gum cleaning with local anesthesia

Scaling root planing
Supragingival ProphylaxisPROCEDURE

Plaque removal

Supragingival prophylaxis

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dental subjects with periodontitis,
  • at least 10 teeth
  • no periodontal (gum) treatment for the last year,
  • no antibiotic for the last 4 months,
  • no vascular access infection.

You may not qualify if:

  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-1710, United States

Location

Related Publications (8)

  • Ioannidou E, Malekzadeh T, Dongari-Bagtzoglou A. Effect of periodontal treatment on serum C-reactive protein levels: a systematic review and meta-analysis. J Periodontol. 2006 Oct;77(10):1635-42. doi: 10.1902/jop.2006.050443.

    PMID: 17032104BACKGROUND

  • Ioannidou E, Shaqman M, Burleson J, Dongari-Bagtzoglou A. Periodontitis case definition affects the association with renal function in kidney transplant recipients. Oral Dis. 2010 Oct;16(7):636-42. doi: 10.1111/j.1601-0825.2010.01665.x.

    PMID: 20412451BACKGROUND

  • Ioannidou E, Swede H, Dongari-Bagtzoglou A. Periodontitis predicts elevated C-reactive protein levels in chronic kidney disease. J Dent Res. 2011 Dec;90(12):1411-5. doi: 10.1177/0022034511423394. Epub 2011 Sep 22.

    PMID: 21940520BACKGROUND

  • Hong BY, Furtado Araujo MV, Strausbaugh LD, Terzi E, Ioannidou E, Diaz PI. Microbiome profiles in periodontitis in relation to host and disease characteristics. PLoS One. 2015 May 18;10(5):e0127077. doi: 10.1371/journal.pone.0127077. eCollection 2015.

    PMID: 25984952BACKGROUND

  • Ioannidou E, Swede H. Disparities in periodontitis prevalence among chronic kidney disease patients. J Dent Res. 2011 Jun;90(6):730-4. doi: 10.1177/0022034511402209. Epub 2011 Mar 21.

    PMID: 21422478RESULT

  • Ioannidou E, Hall Y, Swede H, Himmelfarb J. Periodontitis associated with chronic kidney disease among Mexican Americans. J Public Health Dent. 2013 Spring;73(2):112-9. doi: 10.1111/j.1752-7325.2012.00350.x. Epub 2012 Jul 6.

    PMID: 22775287RESULT

  • Araujo MV, Hong BY, Fava PL, Khan S, Burleson JA, Fares G, Samson W, Strausbaugh LD, Diaz PI, Ioannidou E. End stage renal disease as a modifier of the periodontal microbiome. BMC Nephrol. 2015 Jun 9;16:80. doi: 10.1186/s12882-015-0081-x.

    PMID: 26055269RESULT

  • Ioannidou E, Swede H, Fares G, Himmelfarb J. Tooth loss strongly associates with malnutrition in chronic kidney disease. J Periodontol. 2014 Jul;85(7):899-907. doi: 10.1902/jop.2013.130347. Epub 2013 Nov 11.

    PMID: 24215204RESULT

MeSH Terms

Conditions

PeriodontitisRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Efthimia Ioannidou, DDS, MDS

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 29, 2010

Study Start

August 1, 2009

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

US(1)