Periodontal Therapy in Patients With Rheumatoid Arthritis

Sponsor

Federal University of Rio Grande do Sul (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05502601

Collaborator

Universidad Científica del Sur (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid Periodontitis	Procedure: Non-surgical periodontal treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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 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 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) Other Names: Scaling and root planing

Arm

Intervention/Treatment

No Intervention: Control

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

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

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)

Other Names:

Scaling and root planing

Outcome Measures

Primary Outcome Measures

Changes in the Disease Activity Score with 28-joint counts (DAS 28) [Baseline, 3 and 6 months after treatment]
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
Changes in the Simplified disease activity index (SDAI) [Baseline, 3 and 6 months after treatment]
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.
Changes in the Clinical disease activity index (CDAI) [Baseline, 3 and 6 months after treatment]
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.
Changes in Antibodies to cyclic citrullinated protein (anti-CCP) [Baseline, 3 and 6 months after treatment]
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Changes in rheumatoid factor (RF) [Baseline, 3 and 6 months after treatment]
measurement of the amount of the RF antibody in the blood
Changes in erythrocyte sedimentation rate (ESR) [Baseline, 3 and 6 months after treatment]
measurement of the erythrocyte sedimentation rate in a test tube
C-reactive protein (CRP) [Baseline, 3 and 6 months after treatment]
measurement of the level of c-reactive protein (CRP) in your blood.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)