Impact of nonsurgical periodontal therapy on rheumatoid arthritis patients with gum disease
Effect of Nonsurgical Periodontal Therapy (NSPT) on Inflammatory Mediators, Subgingival Microbiota and Quality of Life Impacts in Rheumatoid Arthritis Subjects with Periodontitis
This study is testing if a teeth cleaning treatment can help people with rheumatoid arthritis who also have gum disease feel better and manage their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Federal Territory) |
| Trial ID | NCT05880303 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of nonsurgical periodontal therapy (NSPT) on patients with rheumatoid arthritis (RA) who also suffer from periodontitis. The approach includes professional mechanical plaque removal and oral hygiene education to address the chronic inflammatory conditions of both diseases. By examining the relationship between periodontal health and RA progression, the study aims to fill existing knowledge gaps regarding their interconnection. Participants will be evaluated based on specific periodontal criteria to ensure they meet the necessary conditions for inclusion.
Who should consider this trial
Good fit: Ideal candidates are rheumatoid arthritis patients who have severe periodontitis and are unresponsive to conventional RA treatments.
Not a fit: Patients with concurrent systemic conditions or those who have recently undergone periodontal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve the overall health and quality of life for patients suffering from both rheumatoid arthritis and periodontitis.
How similar studies have performed: Previous studies have indicated a positive association between periodontal disease and rheumatoid arthritis, suggesting that similar therapeutic approaches may yield beneficial outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All RA patients who fulfill the American College of Rheumatology (formerly the American Rheumatism Association) 2010 revised criteria for the classification of RA and who are unresponsive to conventional RA treatment. 2. At least 4 sites with probing pocket depths (PPD) ≥5mm and 4 sites with clinical attachment level (CAL) ≥3mm distributed in at least 2 quadrants (Papapanou et al, 2018) and will be designated as having Stage II and Stage III periodontitis in addition to Bleeding on Probing (BoP) score of \>30% representing generalised inflammation (Chapple et al, 2017) 3. Patients should have a minimum of 14 teeth present. Exclusion Criteria: 1. Patients who are on antibiotic use during the previous 3 months before study 2. Patients who have received nonsurgical periodontal treatment within 6 months and surgical periodontal treatment within 12 months before the study. 3. Patients who have any concurrent systemic or debilitating conditions such as uncontrolled diabetes. 4. Non Malaysian subjects 5. Patients who are pregnant 6. Presence of acute dental pain or infections
Where this trial is running
Kuala Lumpur, Federal Territory
- Universiti Malaya — Kuala Lumpur, Federal Territory, Malaysia (Recruiting)
Study contacts
- Principal investigator: Rathna Devi Vaithilingam, MCD(Perio) — Universiti Malaya
- Study coordinator: Rathna Devi Vaithilingam, MCD(Perio)
- Email: rathna@um.edu.my
- Phone: +60162210065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.