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Rheumatoid ArthritisNCT02379975

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

A study testing Non-surgical Periodontal Therapy in people with Rheumatoid Arthritis and Periodontitis, run by CAIO VINICIUS GONÇALVES ROMAN TORRES.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis, Periodontitis
What is being tested?
Non-surgical Periodontal Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
No sites listed yet
Study dates
Feb 2013to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

About this study

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).

Read the 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.

Being tested
Non-surgical Periodontal Therapy
Medical subject headings
Arthritis, Rheumatoid, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-surgical Periodontal TherapyProcedure or surgery

    Also called periodontal scaling

Study groups in NCT02379975
Study groupRoleWhat they receive
rheumatoid arthristisExperimentalindividuals with rheumatoid arthritis
Receives: Procedure: Non-surgical Periodontal Therapy
healthActive comparatorhealthy individuals
Receives: Procedure: Non-surgical Periodontal Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. periodontal probing depth (PD)

    Measured: 90 days after periodontal therapy

Secondary outcomes (4)
  1. plaque index (PI)

    Measured: 90 days after periodontal therapy

  2. gingival index (GI)

    Measured: 90 days after periodontal therapy

  3. blood test erythrocyte sedimentation rate (ESR)

    Measured: 90 days after periodontal therapy

  4. blood test C-reactive protein (CRP)

    Measured: 90 days after periodontal therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379975
Sponsor's protocol ID
SantosMU 01
Status last verified
Mar 2015
First submitted
7 Feb 2015
Last updated
5 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25657894
  • 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.

    PubMed 25206939
  • 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.

    PubMed 24782175

Questions about this trial

What is this clinical trial studying?

A study testing Non-surgical Periodontal Therapy in people with Rheumatoid Arthritis and Periodontitis, run by CAIO VINICIUS GONÇALVES ROMAN TORRES.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

periodontal probing depth (PD) (time frame: 90 days after periodontal therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379975, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.

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