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Periodontal Therapy in Patients With Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid, Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Peru
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring C-reactive protein, Periodontal diseases, Periodontitis, Rheumatoid arthritis, Scaling and root planning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Universidad Cientifica del Sur

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Non-surgical periodontal treatment

Arm Description

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 In those cases presenting periodontal disease progression in a single tooth, the patients will be treated and withdrawn from the study

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)

Outcomes

Primary Outcome Measures

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
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.
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.
Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Changes in rheumatoid factor (RF)
measurement of the amount of the RF antibody in the blood
Changes in erythrocyte sedimentation rate (ESR)
measurement of the erythrocyte sedimentation rate in a test tube
C-reactive protein (CRP)
measurement of the level of c-reactive protein (CRP) in your blood.

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2022
Last Updated
November 4, 2022
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Universidad Científica del Sur
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1. Study Identification

Unique Protocol Identification Number
NCT05502601
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Universidad Científica del Sur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Periodontitis
Keywords
C-reactive protein, Periodontal diseases, Periodontitis, Rheumatoid arthritis, Scaling and root planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Non-surgical periodontal treatment
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Other Intervention Name(s)
Scaling and root planing
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes in the Disease Activity Score with 28-joint counts (DAS 28)
Description
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
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in the Simplified disease activity index (SDAI)
Description
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.
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in the Clinical disease activity index (CDAI)
Description
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.
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in Antibodies to cyclic citrullinated protein (anti-CCP)
Description
measurement of CCP (cyclic citrullinated peptide) antibodies in the blood
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in rheumatoid factor (RF)
Description
measurement of the amount of the RF antibody in the blood
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in erythrocyte sedimentation rate (ESR)
Description
measurement of the erythrocyte sedimentation rate in a test tube
Time Frame
Baseline, 3 and 6 months after treatment
Title
C-reactive protein (CRP)
Description
measurement of the level of c-reactive protein (CRP) in your blood.
Time Frame
Baseline, 3 and 6 months after treatment
Secondary Outcome Measure Information:
Title
Changes in Probing pocket depth (PPD)
Description
Measurement of pocket depth with periodontal probe in 6 sites per tooth
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in Clinical attachment level (CAL)
Description
Measurement from the cemento-enamel junction to the total probing depth in 6 sites per tooth
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in Bleeding on probing (BOP)
Description
Bleeding present or absent within 20 s after palpation in 6 sites per tooth
Time Frame
Baseline, 3 and 6 months after treatment
Title
Changes in Plaque index (PI)
Description
Presence or absence of bacterial plaque in 6 sites per tooth
Time Frame
Baseline, 3 and 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Vergara, MS
Phone
51994968218
Email
avergarabuenaventura@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Vergara
Organizational Affiliation
Universidad Cientifica del Sur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Cientifica del Sur
City
Lima
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29221594
Citation
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Citation
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Periodontal Therapy in Patients With Rheumatoid Arthritis

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