Prevalence and severity of periodontitis in patients with rheumatoid arthritis (RA) and the effects of treatment
| ISRCTN | ISRCTN16761141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16761141 |
| Secondary identifying numbers | 2009/792-31/4 |
- Submission date
- 14/07/2017
- Registration date
- 22/08/2017
- Last edited
- 07/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Periodontitis is a chronic inflammatory disease affecting the tissue surrounding the teeth, and if left untreated it may result in bone damage and subsequent tooth loss. The disease is very common worldwide, in Sweden affecting approximately 1/3 of the population. Rheumatoid arthritis (RA) is a lifelong autoimmune disease, where the normally protective immune system attacks the joints, resulting in swelling, stiffness and pain. This incurable disease affects approximately 1% of the world’s population, mostly women. Previous studies have shown that patients with RA may have an increased risk of periodontitis in general and that non-surgical periodontal treatment may have beneficial effects on RA disease activity. This study aims to investigate the severity of periodontitis in patients with RA and whether frequent periodontal treatment (every three months) results in the improvement of RA disease activity and periodontal parameters in patients with RA and periodontitis.
Who can participate?
Patients with RA and periodontal disease, ≥ 18
What does the study involve?
Participants receive a dental examination at the beginning of the study. Those with periodontitis will be randomly divided into one of two groups. Those in the first group receive a more frequent periodontal treatment every three months, and those in the second group receive periodontal treatment only at the first visit. The periodontal treatment includes oral hygiene instructions and the removal of plaque and tartar by a dental professional. Patients with severe periodontitis in need of specialist treatment are referred to and treated by a dentist who specializes in periodontal disease/a periodontist.
What are the possible benefits and risks of participating?
The main benefits of participating in the study include surveillance and treatment of the periodontal disease performed frequently (every three months) by a dentist. Also, the patients in the control group benefit from conventional periodontal treatment at the inclusion in the study. The side effects of periodontal treatment include sore gums and gum recession due to reduced inflammation. This is a low-risk study since all the participants receive conventional periodontal treatment during the first visit as well as surveillance of the periodontitis throughout the course of the study.
Where is the study run from?
Karolinska University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
May 2009 to December 2027
Who is funding the study?
Partly funded by the Stockholm County Council, the collaborative European Union's FP7 Research Project TRIGGER, Karolinska Institutet, the Swedish Research Council, the Swedish Dental Society and others.
Who is the main contact?
1. Associate Professor Tülay Yucel-Lindberg
Tulay.Lindberg@ki.se
2. PhD, DDS, Kaja Eriksson
kaja.eriksson@ki.se
3. PhD, DDS, Carina Fei
carina.fei@ki.se
Contact information
Scientific
Department of Dental Medicine
Division of periodontology
Karolinska Institutet
Stockholm
141 04
Sweden
 ORCID ID |
0000-0003-0129-8809 |
|---|
Study information
| Study design | Prospective randomized interventional clinical controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The severity of periodontitis and the effects of periodontal treatment on disease activity of patients with rheumatoid arthritis as well as the influence of medication on periodontitis: A randomized controlled trial |
| Study acronym | Periodontitis in RA (PEIRA) |
| Study objectives | The hypotheses of this study are: 1. Severe form of periodontitis is more common in seropositive (ACPA/RF) patients with RA as compared to seronegative. 2. Frequent periodontal treatment reduces rheumatoid arthritis disease activity, and related autoimmune and inflammatory parameters. 3. The microbial profile differs based on rheumatological and/or periodontal characteristics in patients with RA. |
| Ethics approval(s) | 1. Regional Ethical Review Board Stockholmm, 10/06/2009, ref: Dnr 2009/792-31/4 2. Regional Ethical Review Board Stockholmm, 30/04/2015, ref: 2015/766-32 |
| Health condition(s) or problem(s) studied | Periodontitis and Rheumatoid Arthritis |
| Intervention | After a full-mouth dental and periodontal examination, participants with periodontitis are randomized to one of two groups. Those in the first group receive conventional periodontal treatment only at the time of inclusion into the study (control group). Those in the second group undergo the periodontal treatment every three months (intervention group) for one year year. The conventional periodontal treatment includes oral hygiene instructions, supra- and subgingival scaling and root planning. Patients in need of specialist treatment (e.g. surgical periodontal treatment) are remitted to periodontal clinic. Participants are assessed for their rheumatoid arthritis activity at baseline and at the study end. Participants are also evaluated for their periodontal parameters such as probing pocket depth, clinical attachment loss, antibodies, microbial profiles and inflammatory mediators. |
| Intervention type | Other |
| Primary outcome measure | 1. Rheumatoid arthritis (RA) disease activity is measured using the DAS28 score, HAQ score at baseline and one year 2. Periodontal parameters (such as probing pocket depth, clinical attachment loss) are measured using the methods of measurement of periodontal disease/parameters at baseline and months three, six, nine, and twelve |
| Secondary outcome measures | 1. The microbial profile is assessed using sequencing technology throughout the study (the specific time points depend on the availability of the resources as well as the instruments at core facility) 2. Antibody levels (such as ACPA/RF, periodontal pathogens etc) are measured using multiplex immunoassay, nephelometry and/or ELISA technique at baseline and one year 3. Levels of inflammatory mediators are measured using Luminex immunoassay at baseline and one year |
| Overall study start date | 01/05/2009 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. ≥ 18 years of age 2. Fulfilling the 2010 ACR criteria for RA 3. Moderate to severe periodontitis, defined according to the classification criteria of the CDC Working Group meant for usage in Population-Based Surveillance of Periodontitis 4. Written informed consent to participate 5. Swedish national registration number |
| Key exclusion criteria | 1. Antibiotic treatment ≤3 months prior to inclusion into the study 2. Periodontal treatment (surgical or non-surgical) ≤3 months prior to inclusion into the study 3. Pregnancy 4. Simultaneous participation in other interventional studies |
| Date of first enrolment | 01/12/2015 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centre
171 76 Stockholm (Solna)
Stockholm
141 86
Sweden
Sponsor information
University/education
Karolinska Institutet
Deptartment of Dental Medicine
Huddinge
Stockholm
SE-141 04
Sweden
"ROR" |
https://ror.org/04hmgwg30 |
|---|
Funders
Funder type
Not defined
No information available
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
No information available
No information available
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal with intent to publish 2019/2020 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
07/03/2025: The following changes were made:
1. The overall study end date was changed from 31/12/2026 to 31/12/2027
2. The target number of participants was changed from 100 to 150.
3. The recruitment end date was changed from 31/12/2025 to 31/12/2026.
12/12/2023: The following changes have been made:
1. The recruitment end date was changed from 31/12/2023 to 31/12/2025.
2. The overall study end date was changed from 31/12/2024 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2027.
26/05/2021: The intention to publish date has been changed from 01/01/2021 to 31/12/2025.
24/05/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2017 to 31/12/2023.
2. The overall trial end date has been changed from 31/12/2021 to 31/12/2024.
09/12/2019: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2018 to 31/12/2021.
2. The intention to publish date was changed from 01/01/2020 to 01/01/2021.
