Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Periodontal Care on Rhematoid Arthritis in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE May 1, 2018
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
change in clinical attachment loss [ Time Frame: Two three monthly follow ups ]
less than 2mm - improvement, more than 3 mm - getting worse
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Periodontal Care on Rhematoid Arthritis in Uganda
Official Title  ICMJE RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Rheumatoid Arthritis
  • Periodontal Diseases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Procedure: Scaling and polishing
    • Other: oral hygiene instructions
  • 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
    Intervention: Other: oral hygiene instructions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2018)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William Buwembo, PhD +256 751 414863 wbuwembo@gmail.com
Contact: Mark KadduMukasa, PhD +256 772 633475 mkaddumukasa@chs.mak.ac.ug
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03513263
Other Study ID Numbers  ICMJE SBS 457
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Makerere University
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ian Munabi, PhD MakCHS
PRS Account Makerere University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP