TREATMENT OF PERIODONTAL DISEASE IN SYSTEMIC LUPUS ERYTEMATOSUS
Research type
Research Study
Full title
TREATMENT OF PERIODONTAL DISEASE IN SYSTEMIC LUPUS ERYTEMATOSUS. A PILOT RANDOMIZED CONTROLLED CLINICAL TRIAL(student study)
IRAS ID
250262
Contact name
Coziana Ciurtin
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2019/06/124, Periodontal study number
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Many studies have conducted to evaluate the relationship of systemic inflammatory diseases with periodontal disease. Previous evaluations suggest that there is no significant association between patients with SLE and PD. However, some of the studies have shown relevancy between these two inflammatory diseases and have suggested to explore more for further knowledge. The aim of the study is to establish and investigate a relationship between SLE and Periodontitis. The study which will take place in one centre and will recruit 30 patients which will enter a pilot randomized controlled trial. Individuals enrolled into the study will be randomly assigned to the test or control group in a 1:1 ratio. Study will be divided in to six visits for the patients and the length of the study will be of 6 months. Visit 1 will be consisting of Screening including consent and Periodontal examination of the patients. Visit 2 includes OPg, Comprehensive periodontal examination recording, Blood samples collection vascular function assessment and OCT. Intensive periodontal treatment (IPT) for test group and control periodontal treatment (CPT) for control group including medical history recording according to group allocation in visit 3 for control group and (3a and 3b) for test group will take place. Follow ups after two months will be conducted in Visit 4 for both groups including Demographics, medical history and concomitant medications recording, comprehensive periodontal examination recording, OCT, blood samples/saliva samples collection and vascular function assessment. Visit 3 and 5 will be conducted as periodontal treatment (IPT for test group and CPT for the control group), medical history recording, including demographics, QRISK3 questionnaire (Visit 2 and visit only) to assess the cardio-vascular risk medical history and concomitant medications recording, comprehensive periodontal examination recording, blood samples collection and vascular function assessment. Last visit will be 6 months follow up.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1976
Date of REC Opinion
22 Jan 2020
REC opinion
Further Information Favourable Opinion