Periodontal Therapy in Patients With Rheumatoid Arthritis

November 4, 2022 updated by: Alex Nogueira Haas, Federal University of Rio Grande do Sul

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Peru
      • Lima, Peru
        • Universidad Cientifica del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Disease Activity Score with 28-joint counts (DAS 28)
Time Frame: 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
Baseline, 3 and 6 months after treatment
Changes in the Simplified disease activity index (SDAI)
Time Frame: 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.
Baseline, 3 and 6 months after treatment
Changes in the Clinical disease activity index (CDAI)
Time Frame: 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.
Baseline, 3 and 6 months after treatment
Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
Time Frame: Baseline, 3 and 6 months after treatment
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Baseline, 3 and 6 months after treatment
Changes in rheumatoid factor (RF)
Time Frame: Baseline, 3 and 6 months after treatment
measurement of the amount of the RF antibody in the blood
Baseline, 3 and 6 months after treatment
Changes in erythrocyte sedimentation rate (ESR)
Time Frame: Baseline, 3 and 6 months after treatment
measurement of the erythrocyte sedimentation rate in a test tube
Baseline, 3 and 6 months after treatment
C-reactive protein (CRP)
Time Frame: Baseline, 3 and 6 months after treatment
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)
Time Frame: Baseline, 3 and 6 months after treatment
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)
Time Frame: Baseline, 3 and 6 months after treatment
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)
Time Frame: Baseline, 3 and 6 months after treatment
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)
Time Frame: Baseline, 3 and 6 months after treatment
Presence or absence of bacterial plaque in 6 sites per tooth
Baseline, 3 and 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Universidad Científica del Sur

Investigators

  • Principal Investigator: Andrea Vergara, Universidad Cientifica del Sur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 15, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

August 12, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CientificaDelSur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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