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Treatment of Periodontal Disease in Systemic Lupus Erythematosus

NCT04046172 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-12

No results posted yet for this study

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

Interventions

PROCEDURE

supra/sub gingival root surface debridement

The test group will undergo Intensive periodontal treatment (IPT)

PROCEDURE

supra-gingival scaling and polishing

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Francesco D'Aiuto, PhD · Unit of Periodontology Eastman Dental Institute,UCL.

  • Coziana Ciurtin, PhD · Department of Rheumatology, UCLH.

  • Marco Orlandi, PhD · Unit of Periodontology Eastman Dental Institute,UCL.

  • Jacopo Buti, PhD · Unit of Periodontology Eastman Dental Institute,UCL.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-07-01
Completion
2023-06-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046172 on ClinicalTrials.gov