- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kampala, Ouganda
- Recrutement
- Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
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Contact:
- Mark KadduMukasa, PhD
- Numéro de téléphone: +256 772 633475
- E-mail: mkaddumukasa@chs.mak.ac.ug
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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
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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
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Comparateur factice: 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
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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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in Disease Activity score of 28 joints
Délai: Two three monthly follow ups
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≤ 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in clinical attachment loss
Délai: Two three monthly follow ups
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less than 2mm - improvement, more than 3 mm - getting worse
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Two three monthly follow ups
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ian Munabi, PhD, MakCHS
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SBS 457
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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