Status:
UNKNOWN
Treatment of Periodontal Disease in Systemic Lupus Erythematosus
Lead Sponsor:
University College, London
Conditions:
Systemic Lupus Erythematosus
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to: Part 1 - Baseline Comparisons The primary objective of Part 1 is to: Investigate the association between SLE and a measures of vascular health (brachial a...
Detailed Description
The primary endpoints of this study are in two parts. One part is to quantify the vascular health in response to PD as a static point prior to active therapy compared to participants with SLE and heal...
Eligibility Criteria
Inclusion
- Male/Female Subject must be 18 years of age or over.
- Patients with 4 or more criteria for juvenile systemic lupus erythematosus (JSLE) or SLE according to the American College of Rheumatology (ACR) 1997 criteria or SLICC 2012 criteria or biopsy proven lupus nephritis with one additional supportive test on at least two occasions (positive Anti-nuclear antibodies (ANA), anti-dsDNA antibodies or anti-Sm antibodies).
- Presence of moderate to severe periodontitis (at least 30 pockets with Probing depth equal or greater than 5mm).
- Subject must have voluntarily signed the informed consent.
Exclusion
- Pregnancy or breastfeeding.
- Having fewer than 15 teeth.
- Subject knowingly has HIV or Hepatitis.
- Subject is not capable to give informed consent.
- Presence of concomitant rheumatoid arthritis, Sjogren syndrome, diabetes mellitus.
- Smoking.
- Subject on anticoagulants.
- Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
- Subjects who received periodontal treatment within 6 months from the baseline
- \-
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04046172
Start Date
November 1 2021
End Date
June 1 2023
Last Update
October 12 2021
Active Locations (1)
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1
Eastman clinical investigation centre (ECIC) Eastman Dental Institute.
London, United Kingdom, wc1 x8ld