Periodontal Treatment in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis, Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Non-surgical periodontal therapy
Sponsored by

About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- periodontal treatment or use of antibiotics in the previous 3 months.
- diabetes, liver disease, head and neck radiation therapy.
- pregnancy
- HIV
- use of cyclosporine.
- Smoking, use of hypertension and hyperlipidemia medication were not exclusion criteria and were recorded accordingly.
Sites / Locations
- Facultad de Odontologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
group with rheumatoid arthritis
group without rheumatoid arthritis
Arm Description
Non-surgical periodontal therapy (NSPT)
Non-surgical periodontal therapy (NSPT)
Outcomes
Primary Outcome Measures
Change in C reactive protein
change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.
Secondary Outcome Measures
Change in rheumatoid factor (RF)
change in RF levels (UI/mL) measured as the difference between the baseline and 3-month examination.
Change in anti-citrullinated protein antibodies (ACPAs)
change in ACPA levels (UI/mL) measured as the difference between the baseline and 3-month examination
Change in periodontal attachment level (PAL)
change in PAL (mm) measured as the difference between the baseline and 3-month examination
Change in probing depth (PD)
change in PD (mm) measured as the difference between the baseline and 3-month examination
Change in bleeding on probing (BOP)
change in BOP (%) measured as the difference between the baseline and 3-month examination
Change in microbial counts
change in subgingival microbial counts (% total colony counts) measured as the difference between the baseline and 3-month examination
Change in quality of life
Change in The Short Form ( SF36) Health Survey measured as the difference between the baseline and 3-month examination. It is converted to a 0-100 scale.The lower the score the more disability. The higher the score the less disability.
Change in oral health profile
Change in Oral Health Impact Profile (OHIP-14) measured as the difference between the baseline and 3-month examination. The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. Higher scores indicate worse and lower scores indicate better oral health quality of life.
Full Information
NCT ID
NCT04658615
First Posted
November 23, 2020
Last Updated
September 28, 2021
Sponsor
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT04658615
Brief Title
Periodontal Treatment in Rheumatoid Arthritis Patients
Official Title
Effects of Non-surgical Periodontal Therapy (NSPT) in Patients With and Without Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Antioquia
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
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)
Detailed Description
After participants are screened for inclusion, serum samples will be collected for the analysis of C-reactive protein (CRP; mg/L), rheumatoid factor (RF; UI/mL) and anti-citrullinated protein antibodies (ACPAs; UI/mL) in a reference laboratory. A complete periodontal chart will be carried out at six sites per tooth excluding third molars by a single experienced clinician using a calibrated probe (Hu-Friedy Mfg. Co.). Subgingival plaque samples will be collected by means of paper points inserted to the bottom of the pocket and processed immediately for culture analysis and detection of Porphyromonas gingivalis. RA patients will be examined by an experienced rheumatologist to determine their Disease Activity Score (DAS-28). All examinations will be taken at baseline and repeated 3 months after intervention.
Non-surgical periodontal therapy (NSPT) will be administered on the following 5 days of inclusion. A single 1-hour session of full-mouth debridement with an ultrasonic device will be carried out in each participant under local anesthesia by an experienced clinician. After NSPT is completed, each patient will receive oral hygiene instructions and oral care pack including toothbrush and toothpaste (toothbrush Vitis Encias Medium; Toothpaste Vitis Encias; Dentaid, Colombia).
Demographic ,clinical history as well as medication data for all participants will be collected. Periodontal parameters of PD (mm), PAL (mm) and BOP (%) will be recorded at each visit. The stage and grade of periodontitis will be established according to the new classification of periodontal diseases (Papapanou et al. 2018). The clinician who records data will not be blinded to the condition of the patients.
Sample size was calculated to detect a 50 % change in CRP with a power of >80% (alpha 0,05) which resulted in 15 per group (Cosgarea et al. 2018). Considering possible dropouts, 20 participants will be included per group. Randomization will not be performed since the purpose was to compare the effects of NSPT in patients with and without RA. The clinical investigator who records periodontal parameters will be calibrated for repeated measurements before patient inclusion (Kappa value was ≥0.80 for PAL and PD). Continuous variables will be presented as the mean and 95% confidence interval (CI) or median [interquartile range] when appropriate. Change in biochemical markers (CRP, RF, ACPAs) and periodontal parameters (PAL, PD, BOP, microbial counts) will be expressed as the delta (∆) from baseline to 3 months after intervention. Differences in means will be determined by the student t test for paired and unpaired samples or non-parametric tests when appropriate. Categorical variables will be presented as frequencies (%) and analyzed in contingency tables and X2. Logistic regression analysis for categorical variables and linear models will be used to test for associations and the odds ratio with 95%CI will be calculated. The primary analysis will be performed as intention to treat and then compared to per-protocol analysis results. The level of statistical significance will be set at 5% (P≤0,05).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group with rheumatoid arthritis
Arm Type
Other
Arm Description
Non-surgical periodontal therapy (NSPT)
Arm Title
group without rheumatoid arthritis
Arm Type
Other
Arm Description
Non-surgical periodontal therapy (NSPT)
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia
Primary Outcome Measure Information:
Title
Change in C reactive protein
Description
change in C-reactive protein levels (mg/L) measured as the difference between the baseline and 3-month examination.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in rheumatoid factor (RF)
Description
change in RF levels (UI/mL) measured as the difference between the baseline and 3-month examination.
Time Frame
3 months
Title
Change in anti-citrullinated protein antibodies (ACPAs)
Description
change in ACPA levels (UI/mL) measured as the difference between the baseline and 3-month examination
Time Frame
3 months
Title
Change in periodontal attachment level (PAL)
Description
change in PAL (mm) measured as the difference between the baseline and 3-month examination
Time Frame
3 months
Title
Change in probing depth (PD)
Description
change in PD (mm) measured as the difference between the baseline and 3-month examination
Time Frame
3 months
Title
Change in bleeding on probing (BOP)
Description
change in BOP (%) measured as the difference between the baseline and 3-month examination
Time Frame
3 months
Title
Change in microbial counts
Description
change in subgingival microbial counts (% total colony counts) measured as the difference between the baseline and 3-month examination
Time Frame
3 months
Title
Change in quality of life
Description
Change in The Short Form ( SF36) Health Survey measured as the difference between the baseline and 3-month examination. It is converted to a 0-100 scale.The lower the score the more disability. The higher the score the less disability.
Time Frame
3 months
Title
Change in oral health profile
Description
Change in Oral Health Impact Profile (OHIP-14) measured as the difference between the baseline and 3-month examination. The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. Higher scores indicate worse and lower scores indicate better oral health quality of life.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
periodontal treatment or use of antibiotics in the previous 3 months.
diabetes, liver disease, head and neck radiation therapy.
pregnancy
HIV
use of cyclosporine.
Smoking, use of hypertension and hyperlipidemia medication were not exclusion criteria and were recorded accordingly.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier E Botero, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facultad de Odontologia
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
00000
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw data will be available at the end of the study upon request
IPD Sharing Time Frame
june 2021 to june 2022
IPD Sharing Access Criteria
For secondary analyses upon request and giving full credits and participation
Citations:
PubMed Identifier
35431355
Citation
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.
Results Reference
derived
Learn more about this trial
Periodontal Treatment in Rheumatoid Arthritis Patients
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