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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379975
• Other study ID #: SantosMU 01
• Status: Completed
• Phase: N/A
• First received: February 7, 2015
• Last updated: March 1, 2015
• Start date: February 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Santos Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 through clinical periodontal parameters and laboratory tests for CRP (C- reactive protein) and ESR (erythrocyte sedimentation rate).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis
• Rheumatoid Arthritis

Intervention

Procedure:
• Non-surgical Periodontal Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CAIO VINICIUS GONÇALVES ROMAN TORRES

References & Publications (3)

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. — View 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. Review. — View 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;2:20-29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periodontal probing depth (PD)		90 days after periodontal therapy	Yes
Secondary	plaque index (PI)		90 days after periodontal therapy	Yes
Secondary	gingival index (GI)		90 days after periodontal therapy	Yes
Secondary	blood test erythrocyte sedimentation rate (ESR)		90 days after periodontal therapy	Yes
Secondary	blood test C-reactive protein (CRP)		90 days after periodontal therapy	Yes