Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis
1 other identifier
interventional
56
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable rheumatoid-arthritis
Started Feb 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 7, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedMarch 5, 2015
March 1, 2015
1 year
February 7, 2015
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
EXPERIMENTALindividuals with rheumatoid arthritis
health
ACTIVE COMPARATORhealthy individuals
Interventions
Eligibility Criteria
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: 25657894BACKGROUNDOlsen 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: 25206939BACKGROUNDMikuls 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
Condition Hierarchy (Ancestors)
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