NCT03513263

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 1, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 16, 2018

Last Update Submit

April 29, 2018

Conditions

Rheumatoid ArthritisPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • change in Disease Activity score of 28 joints

    ≤ 3.2- inactive, \>3.2 but ≤ 5.1 - moderate and \> 5.1- very active

    Two three monthly follow ups

Secondary Outcomes (1)

  • change in clinical attachment loss

    Two three monthly follow ups

Study Arms (2)

Scaling and polishing plus oral hygiene instruction

ACTIVE COMPARATOR

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 polishingOther: oral hygiene instructions

only oral hygiene instructions

SHAM COMPARATOR

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

Interventions

Scaling and polishingPROCEDURE

An electronic scaler will be used to clean the gums

Scaling and polishing plus oral hygiene instruction
oral hygiene instructionsOTHER

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

Scaling and polishing plus oral hygiene instructiononly oral hygiene instructions

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidPeriodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Ian Munabi, PhD

    MakCHS

    STUDY DIRECTOR

Central Study Contacts

William Buwembo, PhD

CONTACT

+256 751 414863wbuwembo@gmail.com

Mark KadduMukasa, PhD

CONTACT

+256 772 633475mkaddumukasa@chs.mak.ac.ug

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participants will not know the arm of the study they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

May 1, 2018

Study Start

September 1, 2017

Primary Completion

September 1, 2019

Study Completion

December 31, 2019

Last Updated

May 1, 2018

Record last verified: 2018-03

Locations

UG(1)