Periodontal Therapy in Patients With Rheumatoid Arthritis

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05502601
• Other study ID #: CientificaDelSur
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2022
• Source: Federal University of Rio Grande do Sul
• Contact: Andrea Vergara, MS
• Phone: 51994968218
• Email: avergarabuenaventura[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Periodontitis

Intervention

Procedure:
• Non-surgical periodontal treatment
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)

Locations

Country	Name	City	State
Peru	Universidad Cientifica del Sur	Lima

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Universidad Científica del Sur

Country where clinical trial is conducted

Peru, 

References & Publications (10)

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, Ménard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovský 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. — View Citation

Calderaro DC, Corrêa 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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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, Lázaro 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. — View Citation

Silvestre FJ, Silvestre-Rangil J, Bagán L, Bagán 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Changes in rheumatoid factor (RF)	measurement of the amount of the RF antibody in the blood	Baseline, 3 and 6 months after treatment
Primary	Changes in erythrocyte sedimentation rate (ESR)	measurement of the erythrocyte sedimentation rate in a test tube	Baseline, 3 and 6 months after treatment
Primary	C-reactive protein (CRP)	measurement of the level of c-reactive protein (CRP) in your blood.	Baseline, 3 and 6 months after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in Plaque index (PI)	Presence or absence of bacterial plaque in 6 sites per tooth	Baseline, 3 and 6 months after treatment