- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03513263
Effect of Periodontal Care on Rhematoid Arthritis in Uganda
RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
RESEARCH QUESTIONS
- What is the prevalence of periodontitis among rthematoid arthritis patients attending the Mulago rheumatology clinic?
- Does non-surgical treatment for periodontitis improve the disease activity score in 28 joints of rheumatoid arthritis in this local setting?
- 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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Kampala, Uganda
- Rekrytering
- Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
-
Kontakt:
- Mark KadduMukasa, PhD
- Telefonnummer: +256 772 633475
- E-post: mkaddumukasa@chs.mak.ac.ug
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age 18 years or older (of either gender).
- RA diagnosed at least 2 year before V0.
- DAS28 score between 3.2 and 5.1 during the month preceding V0.
- No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
- Available for all study visits over 6 months
- Presence of at least six natural teeth.
- Ability to give written informed consent.
- Having Periodontal Disease
Exclusion Criteria:
- Chronic disorder requiring chronic or intermittent use of antibiotics.
- Known hypersensitivity to chlorhexidine digluconate.
- Participation in another intervention study.
- Known contraindications to both amoxicillin and clindamycin.
- Known contraindications to dental local anesthetic.
- Pregnancy or lactation or intent to become pregnant
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Scaling and polishing plus oral hygiene instruction
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
|
An electronic scaler will be used to clean the gums
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
|
Sham Comparator: only oral hygiene instructions
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
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
change in Disease Activity score of 28 joints
Tidsram: Two three monthly follow ups
|
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
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Two three monthly follow ups
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
change in clinical attachment loss
Tidsram: Two three monthly follow ups
|
less than 2mm - improvement, more than 3 mm - getting worse
|
Two three monthly follow ups
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Ian Munabi, PhD, MakCHS
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SBS 457
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