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Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-surgical Periodontal Therapy
Sponsored by
CAIO VINICIUS GONÇALVES ROMAN TORRES
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    rheumatoid arthristis

    health

    Arm Description

    individuals with rheumatoid arthritis

    healthy individuals

    Outcomes

    Primary Outcome Measures

    periodontal probing depth (PD)

    Secondary Outcome Measures

    plaque index (PI)
    gingival index (GI)
    blood test erythrocyte sedimentation rate (ESR)
    blood test C-reactive protein (CRP)

    Full Information

    First Posted
    February 7, 2015
    Last Updated
    March 1, 2015
    Sponsor
    CAIO VINICIUS GONÇALVES ROMAN TORRES
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379975
    Brief Title
    Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis
    Official Title
    Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    CAIO VINICIUS GONÇALVES ROMAN TORRES

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    Detailed Description
    This longitudinal study was approved by the Research Committee of the Santos Metropolitan University, and all individuals had access to the terms of consent. A total of 56 individuals with rheumatoid arthritis were assessed, and the investigators selected 12 women with a mean age of 45.38 who had been diagnosed with rheumatoid arthritis (RA) and who also had mild chronic periodontitis (PD). All of the patients were referred from the outpatient specialty medicals service and the rheumatologist's specialty outpatient clinic of the Metropolitan University of Santos diagnosed and evaluated individuals in the test group and the control group. The control group was composed of individuals who initiated periodontal treatment, did not have any systemic involvement, and had probing depth compatible with the individuals in the test group. The criteria for participation in the study included 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. The main parameters for the diagnosis of RA include counting the number of painful joints and the number of swollen joints, inflammatory activity (ESR and PCR), assessment of pain intensity, and assessment of joint mobility and functional capacity. Before the start of periodontal treatment, these tests were performed, and blood tests (ESR and PCR) were requested and evaluated by the rheumatologist in charge. The healthy subjects (control group) also underwent blood tests. Upon completion of amamneses, periodontal clinical examinations were performed by a previously trained and calibrated periodontist, and in the sample studied, 10% were examined twice for each of the clinical criteria in order to obtain the intra-examiner reliability as measured by Kappa statistics (0.87). The investigators observed the clinical parameters of periodontal probing depth (PD) in six points per tooth, and plaque index (PI) and gingival index (GI), conducted dichotomously for cheeks, buccal, mesial, distal and lingual/ palatal. All of the participants received radiographic, periapical, dental examinations in order to check the height level of the cortical bone. Subjects received oral hygiene devices and underwent therapy for full mouth disinfection, and patients followed the protocol of holding two sessions with an interval of less than 24 hours between sessions. At the beginning of each session, oral hygiene instructions were given to each subject individually and the investigators tried to teach patients the correct way of using a brush and floss. The treatment was performed by scraping by a single periodontist who was blinded to the participants and the data obtained in clinical trials. Each participant received seven doses of the individually-based mouthwash chlorhexidine 0.12%, to be used within seven calendar days after execution of the first session of the proposed therapy, and patients were told to always use it after brushing the last thing at night and then to wait 30 minutes to receive the maximum effectiveness of the chlorhexidine. After the procedures for dental scaling and root planing, 90 days passed before reassessment and new periodontal clinical and laboratory (ESR and PCR) tests were performed. Then the participants were referred to clinics operating in the college of Dentistry UNIMES as needed. After tabulating the clinical and laboratory data for the participants included in this study, the data were subjected to statistical analysis. For this, the investigator used the software SPSS 13.0 and 5.0 bioestat. In all analytical situations a significance level of 95% should be adopted (α ≤.05). For each cluster of analytical interest, the characteristic distribution of the sample was tested and among the selected statistical tests being used were the statistical tests ANOVA with two factors (factor "health condition" - healthy or rheumatoid factor and "periodontal treatment" - Immediate evaluation or after periodontal treatment) and the Tukey's test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis, Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    rheumatoid arthristis
    Arm Type
    Experimental
    Arm Description
    individuals with rheumatoid arthritis
    Arm Title
    health
    Arm Type
    Active Comparator
    Arm Description
    healthy individuals
    Intervention Type
    Procedure
    Intervention Name(s)
    Non-surgical Periodontal Therapy
    Other Intervention Name(s)
    periodontal scaling
    Primary Outcome Measure Information:
    Title
    periodontal probing depth (PD)
    Time Frame
    90 days after periodontal therapy
    Secondary Outcome Measure Information:
    Title
    plaque index (PI)
    Time Frame
    90 days after periodontal therapy
    Title
    gingival index (GI)
    Time Frame
    90 days after periodontal therapy
    Title
    blood test erythrocyte sedimentation rate (ESR)
    Time Frame
    90 days after periodontal therapy
    Title
    blood test C-reactive protein (CRP)
    Time Frame
    90 days after periodontal therapy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female gender in control group, probing depth compatible with the individuals in the test group Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25657894
    Citation
    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.
    Results Reference
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    PubMed Identifier
    25206939
    Citation
    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.
    Results Reference
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    PubMed Identifier
    24782175
    Citation
    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.
    Results Reference
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    Evaluation of Non-surgical Periodontal Therapy in Patients With Rheumatoid Arthritis

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