NCT02379975

Brief Summary

Some clinical and epidemiological studies have revealed a high prevalence of periodontitis and tooth loss in patients with rheumatoid arthritis. The aim of this study was to evaluate the efficacy of periodontal scaling and oral hygiene instruction for patients with mild chronic periodontitis and rheumatoid arthritis through clinical periodontal parameters and laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 7, 2015

Last Update Submit

March 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • periodontal probing depth (PD)

    90 days after periodontal therapy

Secondary Outcomes (4)

  • plaque index (PI)

    90 days after periodontal therapy

  • gingival index (GI)

    90 days after periodontal therapy

  • blood test erythrocyte sedimentation rate (ESR)

    90 days after periodontal therapy

  • blood test C-reactive protein (CRP)

    90 days after periodontal therapy

Study Arms (2)

rheumatoid arthristis

EXPERIMENTAL

individuals with rheumatoid arthritis

Procedure: Non-surgical Periodontal Therapy

health

ACTIVE COMPARATOR

healthy individuals

Procedure: Non-surgical Periodontal Therapy

Interventions

Also known as: periodontal scaling
healthrheumatoid arthristis

Eligibility Criteria

Age30 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female gender
  • in control group, probing depth compatible with the individuals in the test group

You may not qualify if:

  • not having any dental procedure performed in the last six months,
  • not having used antibiotic medication in the last six months,
  • except for the use of drugs that could alter salivary flow (antidepressants, anxiolytics, antihistamines, and diuretics among others),
  • not smoking,
  • and not wearing braces.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Payne JB, Golub LM, Thiele GM, Mikuls TR. The Link Between Periodontitis and Rheumatoid Arthritis: A Periodontist's Perspective. Curr Oral Health Rep. 2015;2(1):20-29. doi: 10.1007/s40496-014-0040-9.

    PMID: 25657894BACKGROUND
  • Olsen I, Potempa J. Strategies for the inhibition of gingipains for the potential treatment of periodontitis and associated systemic diseases. J Oral Microbiol. 2014 Aug 18;6. doi: 10.3402/jom.v6.24800. eCollection 2014.

    PMID: 25206939BACKGROUND
  • Mikuls TR, Payne JB, Yu F, Thiele GM, Reynolds RJ, Cannon GW, Markt J, McGowan D, Kerr GS, Redman RS, Reimold A, Griffiths G, Beatty M, Gonzalez SM, Bergman DA, Hamilton BC 3rd, Erickson AR, Sokolove J, Robinson WH, Walker C, Chandad F, O'Dell JR. Periodontitis and Porphyromonas gingivalis in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 May;66(5):1090-100. doi: 10.1002/art.38348.

    PMID: 24782175BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidPeriodontitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD in Periodontology

Study Record Dates

First Submitted

February 7, 2015

First Posted

March 5, 2015

Study Start

February 1, 2013

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03