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Effect of Periodontal Care on Rhematoid Arthritis in Uganda

Primary Purpose

Rheumatoid Arthritis, Periodontal Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Scaling and polishing
oral hygiene instructions
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the UgandaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Scaling and polishing plus oral hygiene instruction

only oral hygiene instructions

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in Disease Activity score of 28 joints
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active

Secondary Outcome Measures

change in clinical attachment loss
less than 2mm - improvement, more than 3 mm - getting worse

Full Information

First Posted
March 16, 2018
Last Updated
April 29, 2018
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT03513263
Brief Title
Effect of Periodontal Care on Rhematoid Arthritis in Uganda
Official Title
RCT: Evaluating the Effect of Oral Care for Periodontitis in Rhematoid Arthritis Patients in Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
the participants will not know the arm of the study they are in.
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scaling and polishing plus oral hygiene instruction
Arm Type
Active Comparator
Arm Description
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
Arm Title
only oral hygiene instructions
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Scaling and polishing
Intervention Description
An electronic scaler will be used to clean the gums
Intervention Type
Other
Intervention Name(s)
oral hygiene instructions
Intervention Description
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 Measure Information:
Title
change in Disease Activity score of 28 joints
Description
≤ 3.2- inactive, >3.2 but ≤ 5.1 - moderate and > 5.1- very active
Time Frame
Two three monthly follow ups
Secondary Outcome Measure Information:
Title
change in clinical attachment loss
Description
less than 2mm - improvement, more than 3 mm - getting worse
Time Frame
Two three monthly follow ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Buwembo, PhD
Phone
+256 751 414863
Email
wbuwembo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark KadduMukasa, PhD
Phone
+256 772 633475
Email
mkaddumukasa@chs.mak.ac.ug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Munabi, PhD
Organizational Affiliation
MakCHS
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology clinic, medical outpatient department, Mulago national referral hospital and the Uganda
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark KadduMukasa, PhD
Phone
+256 772 633475
Email
mkaddumukasa@chs.mak.ac.ug

12. IPD Sharing Statement

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Effect of Periodontal Care on Rhematoid Arthritis in Uganda

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