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Effect of Periodontal Care on Rhematoid Arthritis in Uganda

29. april 2018 opdateret af: Makerere University

RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda

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

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. 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?
  2. 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.
  3. 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Rekruttering
        • Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older (of either gender).
  2. RA diagnosed at least 2 year before V0.
  3. DAS28 score between 3.2 and 5.1 during the month preceding V0.
  4. No change in medication, dose, or formulation in RA treatment during the 3 months preceding V0.
  5. Available for all study visits over 6 months
  6. Presence of at least six natural teeth.
  7. Ability to give written informed consent.
  8. Having Periodontal Disease

Exclusion Criteria:

  1. Chronic disorder requiring chronic or intermittent use of antibiotics.
  2. Known hypersensitivity to chlorhexidine digluconate.
  3. Participation in another intervention study.
  4. Known contraindications to both amoxicillin and clindamycin.
  5. Known contraindications to dental local anesthetic.
  6. Pregnancy or lactation or intent to become pregnant

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / 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
Procedure: Scaling and polishing
An electronic scaler will be used to clean the gums
Andet: 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
Sham-komparator: 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
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in Disease Activity score of 28 joints
Tidsramme: Two three monthly follow ups
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
Two three monthly follow ups

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in clinical attachment loss
Tidsramme: Two three monthly follow ups
less than 2mm - improvement, more than 3 mm - getting worse
Two three monthly follow ups

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Makerere University

Efterforskere

  • Studieleder: Ian Munabi, PhD, MakCHS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2017

Primær færdiggørelse (Forventet)

1. september 2019

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

16. marts 2018

Først indsendt, der opfyldte QC-kriterier

29. april 2018

Først opslået (Faktiske)

1. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SBS 457

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Scaling and polishing

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Betingelser

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Placeringer

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