Periodontal Therapy in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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Aim: A prospective randomized, controlled clinical trial comparing two groups of a cohort of Rheumatoid Arthritis (RA) patients with periodontal disease will be carried out to identify if the effect of non-surgical periodontal therapy is a predictor of remission/ low disease activity (LDA)-remission. Methods: 42 patients with RA and periodontitis from the RA Almenara cohort will be included (ACR 1987 and or ACR/EULAR 2010 criteria with more than 16 years old at diagnosis); those with <6 teeth, current infections, cancer or oral precancerous lesions, diabetics, Sjogren's syndrome, use of antibiotics or drugs associated with dry mouth and dental surgery, will be excluded. Periodontal Disease was defined by the presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according with the 2018 periodontitis diagnostic criteria. Two RA patients groups will be follow up by monthly visits. Patients will be divided into two groups (intervention and no intervention treatment). PD treatment will be performed by a qualified periodontist. No intervention group will receive PD treatment after 6 month visit because ethical principles. Disease activity will be determined according with DAS 28index, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) scores, C-reactive protein (CRP), the erythrocyte sedimentation rate (ESR), and rheumatoid factor levels will be registered before and after PD treatment (baseline, 3 and 6 months visits), and the differences between the groups will be analyzed and compared. Periodontal parameters including probing depth (PD), clinical attachment loss, and sulcus bleeding index (SBI) will be correlated with the factor levels.

Official Title
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Impact of Non-surgical Periodontal Therapy in the Systemic and Clinical Conditions of Patients With Rheumatoid Arthritis: a 6-months Randomized Controlled Trial

Conditions
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Arthritis, Rheumatoid, Periodontitis

Intervention / Treatment
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* Procedure: Non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes Age ≥16 years at the time of diagnosis and who do not meet criteria of overlap with any other autoimmune disease. Presence of six or more permanent teeth in the mouth, excluding third molars. Presence of periodontitis stage 3 or 4 with at least 2 non-adjacent teeth with insertion loss >=5mm, probing depth >=5mm and bleeding on probing according to Tonetti et al.[35]. Willingness to attend all visits for the duration of the study. Exclusion Criteria: Patients with Sjogren's syndrome - Severe ongoing systemic infection. - Associated dental infection - History of oral cavity cancer or precancerous lesion. - Use of local or systemic antibiotics in the last 3 months (including tetracyclines or other medication that could change the periodontal evaluation in the investigator's opinion, such as heparin alendronate, antivitamin K). - Medications that induce gingival hyperplasia (such as phenytoin, warfarin or cyclosporine). - Pregnant or breastfeeding women - Participation in another intervention study. Patients with a history of PD treatment in the last 6 months or previous dental surgery)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will be comprised by those who will not receive any specific oral care intervention. For ethical reasons, the control group will receive periodontal therapy at the Endo of the study (after 6 months). In those cases presenting periodontal disease progression in a single tooth, the patients will be treated and withdrawn from the study | |
| Active Comparator: Non-surgical periodontal treatment<br>Periodontal treatment will be performed with scaling and root planning (SRP).SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes. Oral hygiene instructions (patient education and motivation to control plaque and calculus accumulation) | Procedure: Non-surgical periodontal treatment<br>* SRP will be performed under local anesthesia during a single, 2-hour, full-mouth ultrasonic and hand instrument debridement using curettes. Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)<br>* Other names: Scaling and root planing;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Disease Activity Score with 28-joint counts (DAS 28) | The DAS28 includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), ESR, and a patient global assessment of disease activity (PtGA) or GH (General Health) assessment on a VAS. It may also be calculated using C-reactive protein (CRP) level instead of Westergren ESR the unabbreviated scale title: Disease Activity Score (28-joint counts) A score greater than 5.1 indicates active disease and less than 3.2 indicates well-controlled disease. A score of less of than 2.6 indicates remission | Baseline, 3 and 6 months after treatment | 
| Changes in the Simplified disease activity index (SDAI) | The SDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), provider global assessment of disease activity (PrGA) on a 10-cm VAS, and C-reactive protein (CRP) level in mg/dl. The unabbreviated scale title: Simplified disease SDAI is calculated as follows: SDAI = SJC + TJC +PtGA + EGA (Evaluator Global disease Activity) + CRP. activity index The SDAI has range from 0 to 86. higher scores mean a worse outcome. | Baseline, 3 and 6 months after treatment | 
| Changes in the Clinical disease activity index (CDAI) | The CDAI includes a 28-swollen joint count (28SJC), 28-tender joint count (28TJC), patient global assessment of disease activity (PtGA) on a 10-cm visual analog scale (VAS), and provider global assessment of disease activity (PrGA) on a 10-cm VAS The unabbreviated scale title: Clinical disease activity index The CDAI has range from 0 to 76. higher scores mean a worse outcome. | Baseline, 3 and 6 months after treatment | 
| Changes in Antibodies to cyclic citrullinated protein (anti-CCP) | measurement of CCP (cyclic citrullinated peptide) antibodies in the blood | Baseline, 3 and 6 months after treatment | 
| Changes in rheumatoid factor (RF) | measurement of the amount of the RF antibody in the blood | Baseline, 3 and 6 months after treatment | 
| Changes in erythrocyte sedimentation rate (ESR) | measurement of the erythrocyte sedimentation rate in a test tube | Baseline, 3 and 6 months after treatment | 
| C-reactive protein (CRP) | measurement of the level of c-reactive protein (CRP) in your blood. | Baseline, 3 and 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Probing pocket depth (PPD) | Measurement of pocket depth with periodontal probe in 6 sites per tooth | Baseline, 3 and 6 months after treatment | 
| Changes in Clinical attachment level (CAL) | Measurement from the cemento-enamel junction to the total probing depth in 6 sites per tooth | Baseline, 3 and 6 months after treatment | 
| Changes in Bleeding on probing (BOP) | Bleeding present or absent within 20 s after palpation in 6 sites per tooth | Baseline, 3 and 6 months after treatment | 
| Changes in Plaque index (PI) | Presence or absence of bacterial plaque in 6 sites per tooth | Baseline, 3 and 6 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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C-reactive protein, Periodontal diseases, Periodontitis, Rheumatoid arthritis, Scaling and root planning