Clinical trial NCT05502601: Periodontal Therapy in Patients With Rheumatoid Arthritis
Official title: Impact of Non-surgical Periodontal Therapy in the Systemic and Clinical Conditions of Patients With Rheumatoid Arthritis: a 6-months Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis, Rheumatoid
Periodontitis
Keywords: C-reactive protein
Periodontal diseases
Periodontitis
Rheumatoid arthritis
Scaling and root planning
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Universidad Científica del Sur
First posted: 2022-08-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in the Disease Activity Score with 28-joint counts (DAS 28)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in the Simplified disease activity index (SDAI)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in the Clinical disease activity index (CDAI)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in rheumatoid factor (RF)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in erythrocyte sedimentation rate (ESR)
timeFrame: Baseline, 3 and 6 months after treatment
measure: C-reactive protein (CRP)
timeFrame: Baseline, 3 and 6 months after treatment
Secondary outcomes:
measure: Changes in Probing pocket depth (PPD)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in Clinical attachment level (CAL)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in Bleeding on probing (BOP)
timeFrame: Baseline, 3 and 6 months after treatment
measure: Changes in Plaque index (PI)
timeFrame: Baseline, 3 and 6 months after treatment
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad Cientifica del Sur
Study officials:
affiliation: Universidad Cientifica del Sur
name: Andrea Vergara
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng Z, Meade J, Mankia K, Emery P, Devine DA. Periodontal disease and periodontal bacteria as triggers for rheumatoid arthritis. Best Pract Res Clin Rheumatol. 2017 Feb;31(1):19-30. doi: 10.1016/j.berh.2017.08.001. Epub 2017 Sep 1.
citation: Genco RJ, Sanz M. Clinical and public health implications of periodontal and systemic diseases: An overview. Periodontol 2000. 2020 Jun;83(1):7-13. doi: 10.1111/prd.12344.
citation: Gabriel SE, Michaud K. Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases. Arthritis Res Ther. 2009;11(3):229. doi: 10.1186/ar2669. Epub 2009 May 19.
citation: Schneeberger EE, Citera G, Maldonado Cocco JA, Salcedo M, Chiardola F, Rosemffet MG, Marengo MF, Papasidero S, Chaparro Del Moral R, Rillo OL, Bellomio V, Lucero E, Spindler A, Berman A, Duartes Noe D, Barreira JC, Lazaro MA, Paira SO. Factors associated with disability in patients with rheumatoid arthritis. J Clin Rheumatol. 2010 Aug;16(5):215-8. doi: 10.1097/RHU.0b013e3181e92d25.
citation: Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
citation: Zhao X, Liu Z, Shu D, Xiong Y, He M, Xu S, Si S, Guo B. Association of Periodontitis with Rheumatoid Arthritis and the Effect of Non-Surgical Periodontal Treatment on Disease Activity in Patients with Rheumatoid Arthritis. Med Sci Monit. 2018 Aug 20;24:5802-5810. doi: 10.12659/MSM.909117.
citation: Ceccarelli F, Saccucci M, Di Carlo G, Lucchetti R, Pilloni A, Pranno N, Luzzi V, Valesini G, Polimeni A. Periodontitis and Rheumatoid Arthritis: The Same Inflammatory Mediators? Mediators Inflamm. 2019 May 5;2019:6034546. doi: 10.1155/2019/6034546. eCollection 2019.
citation: Calderaro DC, Correa JD, Ferreira GA, Barbosa IG, Martins CC, Silva TA, Teixeira AL. Influence of periodontal treatment on rheumatoid arthritis: a systematic review and meta-analysis. Rev Bras Reumatol Engl Ed. 2017 May-Jun;57(3):238-244. doi: 10.1016/j.rbre.2016.11.011. Epub 2017 Jan 4. English, Portuguese.
citation: Silvestre FJ, Silvestre-Rangil J, Bagan L, Bagan JV. Effect of nonsurgical periodontal treatment in patients with periodontitis and rheumatoid arthritis: A systematic review. Med Oral Patol Oral Cir Bucal. 2016 May 1;21(3):e349-54. doi: 10.4317/medoral.20974.
citation: Sun J, Zheng Y, Bian X, Ge H, Wang J, Zhang Z. Non-surgical periodontal treatment improves rheumatoid arthritis disease activity: a meta-analysis. Clin Oral Investig. 2021 Aug;25(8):4975-4985. doi: 10.1007/s00784-021-03807-w. Epub 2021 Jan 29.