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this will be an RCT. to determine if non-surgical treatment for periodontitis can improve the disease activity score in 28 joints of rheumatoid arthritis in an African setting. Rheumatoid arthritis patients with periodontal disease will be randomised into an immediate intervention arm and a delayed intervention arm and both groups will be followed for two three monthly periods
RESEARCH QUESTIONS
Problem statement It has been shown that intervention with nonsurgical treatment of periodontitis improved the periodontal condition of patients with periodontitis and RA, with beneficial effects upon the clinical and laboratory test parameters, disease activity scores in 28 joints (DAS28) and erythrocyte sedimentation rate (ESR). However, all the studies included in the reviews involved small samples sizes and follow-up periods of less than 6 months. And locally to our knowledge there is currently no published information looking at the role of periodontal disease among Ugandans with rheumatoid arthritis.
METHODS Objective 1 will be addressed with a cross sectional study design while objective 2 will be a randomized control intervention on a fresh sample of patients from the clinic who will be randomly assigned using computer generated random numbers.
Population : To address the objective 1 a total sample size of 146 randomly selected study participants.
For objective 2 the target sample size of 304 individuals or 152 individuals per group.
Procedures: On arrival to the dental clinic, the selected and previously consented participants will undergo a standardized interview. This will be followed by an oral examination to assess for: registration of plaque, bleeding on probing, probing depth and followed with the calculation of the Periodontal inflamed surface area score and clinical attachment loss, pick crevicular fluid using paper point for follow-up confirmatory polymerase chain reactions (PCR), quantification with quantitative real-time PCR (QPCR) experiments for P. gingivalis. At the end of the examination a peripheral blood sample will be obtained for: erythrocyte sedimentation rate to be factored in the determination of DAS 28 score. The remaining blood sample will be stored in the department of Anatomy for further studies latter pertaining to PD and RA.
Objective 2 RCT study Participants will be randomized into an immediate intervention arm and a delayed intervention arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and polishing plus oral hygiene instruction | Active Comparator | This arm will contain RA participants with PD who will continue with their treatment for RA and also receive the intervention of scaling and polishing plus oral hygiene instructions |
|
| only oral hygiene instructions | Sham Comparator | This arm will contain rheumatoid arthritis (RA) participants with periodontitis who will continue with their treatment for (RA) and also receive only oral hygiene instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and polishing | Procedure | An electronic scaler will be used to clean the gums |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Disease Activity score of 28 joints | ≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active | Two three monthly follow ups |
| Measure | Description | Time Frame |
|---|---|---|
| change in clinical attachment loss | less than 2mm - improvement, more than 3 mm - getting worse | Two three monthly follow ups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Buwembo, PhD | Contact | +256 751 414863 | wbuwembo@gmail.com | |
| Mark KadduMukasa, PhD | Contact | +256 772 633475 | mkaddumukasa@chs.mak.ac.ug |
| Name | Affiliation | Role |
|---|---|---|
| Ian Munabi, PhD | MakCHS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda | Recruiting | Kampala | Uganda |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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scaling and polishing plus oral hygiene instructions will be provided for the intervention arm while only oral hygiene instruction will be provided for the control arm. At the end of the six month follow up the control arm will also be provided with scaling and polishing.
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the participants will not know the arm of the study they are in.
| oral hygiene instructions | Other | It will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |