NCT00937976

Brief Summary

The primary objective is to test the hypothesis that periodontal intervention in dialysis patients who have both periodontal disease and a historically high burden of cardiovascular disease will result in a reduction of inflammatory markers and improvement markers of nutrition health like albumin. Patients will be randomized to one of two treatment arms: intensive periodontal therapy or control-delayed periodontal therapy. Eligible patients will have 5 study visits over 7 to 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration 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, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

July 9, 2009

Last Update Submit

May 4, 2012

Conditions

Periodontal Disease

Keywords

Hemodialysis and peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Serum Albumin, IL-6, CRP

    6 months

Secondary Outcomes (1)

  • HbA1c, periodontal probing

    6 months

Study Arms (2)

Control-delayed periodontal therapy

OTHER
Procedure: Periodontal Scaling and Root Planing

Intensive Periodontal Therapy

OTHER
Procedure: Periodontal Scaling and Root Planing

Interventions

Periodontal Scaling and Root PlaningPROCEDURE

Participants will take antibiotics prior to dental treatment. Periodontal treatment or a deep cleaning (with local anesthesia or numbing) will be performed to remove plaque and tartar around the teeth and gums. A small amount of antibiotics (minocycline) will be placed around the gums to help fight bacteria and inflammation.

Control-delayed periodontal therapyIntensive Periodontal Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of 12 or more teeth
  • Presence of moderate to severe periodontal disease (2 or more teeth with at least 6 mm Clinical Attachment Loss and at least 1 site with Probing Depth \> 5 mm)
  • Receiving dialysis for at least 3 months
  • English speaking
  • Ability and willingness to give written informed consent for participation in the study
  • Age 18 to 80 years
  • Twelve or more teeth

You may not qualify if:

  • Any severe co-morbid conditions likely to affect life expectancy within 1 year (for example, metastatic cancer)
  • Any condition that would, in the judgement of the clinician, be a contraindication to dental treatment
  • Dementia
  • Pregnancy or lactation
  • Inability to take oral medications
  • Allergy or intolerance to minocycline, tetracyclines or polygycolate polymers
  • Allergy to both penicillin and clindamycin
  • Severe dental caries, pulpal or mucosal disease that would interfere with periodontal therapy
  • Inability or unwillingness to follow the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GO Health Center, School of Dentistry, University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Wehmeyer MM, Kshirsagar AV, Barros SP, Beck JD, Moss KL, Preisser JS, Offenbacher S. A randomized controlled trial of intensive periodontal therapy on metabolic and inflammatory markers in patients With ESRD: results of an exploratory study. Am J Kidney Dis. 2013 Mar;61(3):450-8. doi: 10.1053/j.ajkd.2012.10.021. Epub 2012 Dec 20.

    PMID: 23261122DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Steven Offenbacher, DDS, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

August 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

US(1)