Treatment of Periodontal Disease in Systemic Lupus Erythematosus

NCT04046172 | Unknown

• 1 other identifier: 123436
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 artery flow-mediated dilatyation) in patients with Systemic Lupus Erythematosus (SLE) and a healthy periodontium compared to patients with SLE and Periodontitis (PD) Part 2 - Pilot Randomized Clinical Trial To assess the effect of Periodontal Treatment (PT) on the endothelial function in a population of patients suffering from SLE and PD. Secondary Secondary objectives include: Part 1 - Baseline Comparisons The secondary objectives of Part 1 are to investigate the association of:

• Inflammatory biomarkers in saliva and blood and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium
• The oral microbiome using plaque analysis and periodontal status in patients with SLE and PD and those with SLE and a healthy periodontium Part ParPa Part 2 - Pilot Randomized Controlled Trial Evaluate the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD. Evaluate the effect of PT on the B cell panel in a population of patients suffering from SLE and PD. Evaluate effect of PT on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD. Evaluate effect of PT on skin lesions in a population of patients suffering from SLE and PD.

Conditions

Systemic Lupus Erythematosus; Periodontitis

Keywords

Periodontitis; SLE; Lupus

Outcome Measures

Primary Outcomes (1)

• To measure the effect of periodontal treatment on SLE patients

  Endothelial function/dysfunction (vessel wall elasticity) will be observed in the population of SLE patients (30) who will undergo periodontal treatment (before and after) by using Flow mediated dilatation (FMD) which is an ultra-sound scan of brachial artery in visit 2, 4 and 6).

  2 years

Secondary Outcomes (4)

• To measure the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD.

  2 years

• To measure the effect of Periodontal Treatment on the B-cell panel in a population of patients suffering from SLE and PD.

  2 Years

• To measure the effect of Periodontal Treatment on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD.

  2 years

• To measure the effect of Periodontal Treatment on skin lesions in a population of patients suffering from SLE and PD.

  2 years

Study Arms (2)

test group

EXPERIMENTAL

intensive periodontal treatment (IPT)

Procedure: supra/sub gingival root surface debridement

control group

SHAM COMPARATOR

Control periodontal treatment (CPT)

Procedure: supra-gingival scaling and polishing

Interventions

supra/sub gingival root surface debridement PROCEDURE

The test group will undergo Intensive periodontal treatment (IPT)

Also known as: IPT

test group

supra-gingival scaling and polishing PROCEDURE

Control group will receive the Control periodontal treatment (CPT).

Also known as: CPT

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Eastman clinical investigation centre (ECIC) Eastman Dental Institute.

London, wc1 x8ld, United Kingdom

Location

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MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Periodontitis

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Francesco D'Aiuto, PhD

  Unit of Periodontology Eastman Dental Institute,UCL.

  STUDY CHAIR

• Coziana Ciurtin, PhD

  Department of Rheumatology, UCLH.

  PRINCIPAL INVESTIGATOR

• Marco Orlandi, PhD

  Unit of Periodontology Eastman Dental Institute,UCL.

  STUDY CHAIR

• Jacopo Buti, PhD

  Unit of Periodontology Eastman Dental Institute,UCL.

  STUDY CHAIR

Central Study Contacts

Syed Basit Hussain, BDS

CONTACT

+447477024924; syed.hussain.16@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It is a single-blinded study in which cardio-vascular technician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Total 200 Participants for part 1 (baseline). Randomization (Part 2) Control Test group (n=15) control group (n=15)

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: August 6, 2019
• Study Start: November 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)