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Effect of Periodontal Care on Rhematoid Arthritis in Uganda

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ClinicalTrials.gov Identifier: NCT03513263
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Periodontal Diseases Procedure: Scaling and polishing Other: oral hygiene instructions Not Applicable

Detailed Description:
  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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Participant)
Masking Description: the participants will not know the arm of the study they are in.
Primary Purpose: Treatment
Official Title: RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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

Other: 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 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
Other: 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




Primary Outcome Measures :
  1. change in Disease Activity score of 28 joints [ Time Frame: Two three monthly follow ups ]
    ≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active


Secondary Outcome Measures :
  1. change in clinical attachment loss [ Time Frame: Two three monthly follow ups ]
    less than 2mm - improvement, more than 3 mm - getting worse



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513263


Contacts
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Contact: William Buwembo, PhD +256 751 414863 wbuwembo@gmail.com
Contact: Mark KadduMukasa, PhD +256 772 633475 mkaddumukasa@chs.mak.ac.ug

Locations
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Uganda
Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda Recruiting
Kampala, Uganda
Contact: Mark KadduMukasa, PhD    +256 772 633475    mkaddumukasa@chs.mak.ac.ug   
Sponsors and Collaborators
Makerere University
Investigators
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Study Director: Ian Munabi, PhD MakCHS

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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03513263     History of Changes
Other Study ID Numbers: SBS 457
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Periodontal Diseases
Joint Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases