Periodontal Treatment in Rheumatoid Arthritis Patients

NCT04658615 | Completed

• 1 other identifier: 05-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a chronic disease that leads to the loss of teeth. It has been associated to rheumatoid arthritis (RA). Periodontal therapy (NSPT) has been shown to have systemic effects. The objective of this study was to compare the effects of non-surgical periodontal therapy on biochemical parameters of rheumatoid arthritis (RA), periodontal parameters and quality of life in patients with and without RA. Adult patients with and RA and periodontitis can participate in the study. Participants benefit from the effects of conventional tooth cleaning (periodontal therapy) and oral hygiene instructions. There are no significant risk associated with periodontal therapy. The study is conducted at the Universidad de Antioquia in Medellin, Colombia. The study is set to start 2019 and end mid 2021. The study is funded by a grant from the Universidad de Antioquia. Contact person: Javier Enrique Botero (javier.botero@udea.edu.co)

Conditions

Rheumatoid Arthritis; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in C reactive protein

  change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.

  3 months

Secondary Outcomes (8)

• Change in rheumatoid factor (RF)

  3 months

• Change in anti-citrullinated protein antibodies (ACPAs)

  3 months

• Change in periodontal attachment level (PAL)

  3 months

• Change in probing depth (PD)

  3 months

• Change in bleeding on probing (BOP)

  3 months

Study Arms (2)

group with rheumatoid arthritis

OTHER

Non-surgical periodontal therapy (NSPT)

Procedure: Non-surgical periodontal therapy

group without rheumatoid arthritis

OTHER

Non-surgical periodontal therapy (NSPT)

Procedure: Non-surgical periodontal therapy

Interventions

Non-surgical periodontal therapy PROCEDURE

A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia

group with rheumatoid arthritis; group without rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years old; diagnosis of RA according to the American College of Rheumatology with DAS-28 score ≥ 3.2 and no change in RA medication in the previous 3 months;
• at least 15 teeth excluding third molars;
• ≥2 non-adjacent teeth interproximal sites with loss of periodontal attachment level (PAL) ≥ 2 mm; or buccal or oral PAL ≥3 mm with pocketing \>3 mm is detectable at ≥2 teeth.
• Patients without RA met the same criteria except for the diagnosis of RA.

You may not qualify if:

• periodontal treatment or use of antibiotics in the previous 3 months.
• diabetes, liver disease, head and neck radiation therapy.
• pregnancy
• HIV
• use of cyclosporine.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Facultad de Odontologia

Medellín, Antioquia, 00000, Colombia

Location

Related Publications (1)

• Botero JE, Posada-Lopez A, Mejia-Vallejo J, Pineda-Tamayo RA, Bedoya-Giraldo E. Effects of nonsurgical periodontal therapy in patients with rheumatoid arthritis: a prospective before and after study. Colomb Med (Cali). 2021 Sep 30;52(3):e2095051. doi: 10.25100/cm.v52i3.5051. eCollection 2021 Jul-Sep.

  PMID: 35431355 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Periodontitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Javier E Botero, PhD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 8, 2020
• Study Start: January 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: june 2021 to june 2022
• Access Criteria: For secondary analyses upon request and giving full credits and participation

Locations

CO (1)