None listed
Conditions
Brief summary
This study aims to understand how gum inflammation (gingivitis) may affect the immune system in people with rheumatoid arthritis (RA) or those at risk of developing it. Participants will temporarily stop brushing and flossing for up to three weeks under supervision, allowing researchers to observe changes in the gums and immune responses. The study will compare these changes across three groups: people with RA, those at risk, and healthy individuals. We hypothesise that people with RA will show a stronger immune and bacterial response to gingivitis than healthy individuals. The results may help identify early warning signs of RA and improve strategies to prevent joint flare-ups linked to oral health.
Interventions
The comparators are:
1. Rheumatoid Arthritis Group - participants with diagnosed rheumatoid arthritis
2. At-Risk Group - participants who are positive for RA-related antibodies or have joint symptoms but no formal RA diagnosis
All participants will undergo a three-phase study:
1.. Baseline Phase (Day -14 to Day 0): Participants will receive a professional dental cleaning and be instructed to maintain optimal oral hygiene until there is no clinical evidence of gingivitis. This ensures a consiste
The comparators are: 1. Rheumatoid Arthritis Group - participants with diagnosed rheumatoid arthritis 2. At-Risk Group - participants who are positive for RA-related antibodies or have joint symptoms but no formal RA diagnosis All participants will undergo a three-phase study: 1.. Baseline Phase (Day -14 to Day 0): Participants will receive a professional dental cleaning and be instructed to maintain optimal oral hygiene until there is no clinical evidence of gingivitis. This ensures a consistent baseline across participants. 2. Experimental Gingivitis Phase (Day 0 to Day 14–21): Participants will be asked to discontinue all oral hygiene practices (e.g., toothbrushing and flossing) for 14 to 21 days to induce gingivitis in a safe and controlled manner. No dietary restrictions will be imposed. 3. Resolution Phase (14 Days Post-Visit 4): Participants will resume regular oral hygiene practices. Clinical assessments will continue to monitor the resolution of gingival inflammation. The study will consist of six visits: Visit 1 at Day –14, Visit 2 at Day 0, Visit 3 at Day 7, Visit 4 between Day 14 and Day 21, Visit 5 at 7 days post–Visit 4, and Visit 6 at 14 days post–Visit 4. Visit 1: Periodontal measurements, biological sample collections (i.e. saliva, plaque and gingival crevicular fluid), provision of professional cleaning and oral hygiene instruction. Visit 2: Periodontal measurements, biological sample collections (i.e. saliva, plaque, gingival crevicular fluid and blood). Visit 3: Periodontal measurements, biological sample collections (i.e. saliva, plaque and gingival crevicular fluid). Visit 4: Periodontal measurements, biological sample collections (i.e. saliva, plaque, gingival crevicular fluid, blood and gingival tissue). Visit 5: Periodontal measurements, biological sample collections (i.e. saliva, plaque and gingival crevicular fluid). Visit 6: Periodontal measurements, biological sample collections (i.e. saliva, plaque and gingival crevicular fluid) and provision of professional cleaning Each visit may take up to one hour.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for Control Group: • 18 years or older, who can provide informed consent • Systemically healthy individuals • A dentition with a minimum of 24 permanent teeth • Probing pocket depth less than or equal to 4mm at six sites/tooth • Non-smoker/former smoker (quit greater than 6 months ago) only • Willingness to comply with all study requirements and sign informed consent Inclusion Criteria for Rheumatoid Arthritis Group: • Adults aged 18-85 years • Confirmed Rheumatoid Arthritis Diagnosis according to ACR/EULAR 2010 criteria • A dentition with a minimum of 24 permanent teeth • Probing pocket depth less than or equal to 4mm at six sites/tooth • Non-smoker/former smoker (quit greater than 6 months ago) only • Willingness to comply with all study requirements and sign informed consent Inclusion Criteria for At-Risk Rheumatoid Arthritis Group: • Adults aged 18-85 years • Presence of anti-citrullinated protein antibodies or rheumatoid factor or arthralgia without clinical Rheumatoid Arthritis • A dentition with a minimum of 24 permanent teeth • Probing pocket depth less than or equal to 4mm at six sites/tooth • Non-smoker/former smoker (quit greater than 6 months ago) only • Willingness to comply with all study requirements and sign informed consent
Exclusion criteria
Exclusion Criteria for Control Group: • Recent antibiotic or anti-inflammatory use within the past three months • Using any antimicrobial mouthwashes during the study period • Pregnant or lactating • Orthodontic appliances or prostheses that affect gingival margins Exclusion Criteria for Rheumatoid Arthritis Group: • Other systemic diseases that could confound inflammation (e.g. uncontrolled diabetes, autoimmune overlap syndrome) • Recent antibiotic use within the past three months • Using any antimicrobial mouthwashes during the study period • Pregnant or lactating • Orthodontic appliances or prostheses that affect gingival margins Exclusion Criteria for At-Risk Rheumatoid Arthritis Group: • Other systemic diseases that could confound inflammation (e.g. uncontrolled diabetes, autoimmune overlap syndrome) • Recent use of antibiotics within the past three months • Using any antimicrobial mouthwashes during the study period • Pregnant or lactating • Orthodontic appliances or prostheses that affect gingival margins
Outcome results
None listed