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Treatment of Periodontal Disease in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT04046172
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE July 15, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
To measure the effect of periodontal treatment on SLE patients [ Time Frame: 2 years ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • To measure the effect of PT on biomarkers of SLE disease severity/progression in a population of patients suffering from SLE and PD. [ Time Frame: 2 years ]
    30 Patients will be recruited and will run a blood test in visit 2, 4 and 6 to observe the CRP (C-reactive Protein) that is an inflammatory marker before and after Periodontal treatment in patients with SLE.
  • To measure the effect of Periodontal Treatment on the B-cell panel in a population of patients suffering from SLE and PD. [ Time Frame: 2 Years ]
    Since B-cells (lymphocytes) are already unnaturally high in SLE patients we want to see if Periodontal Treatment decreases the total cell load/population by Flow cytometry with the blood samples taken form the (30) SLE patients in visit 2, 4 and 6.
  • To measure the effect of Periodontal Treatment on the systemic inflammatory and oxidative profile of a population of patients suffering from SLE and PD. [ Time Frame: 2 years ]
    Because SLE and Periodontal diseases are both chronic inflammatory diseases Nitrous oxide production is raised in both diseases leading to self inflicted tissue damage. Blood will be drawn form the (30) patients with SLE and will run a D-ROM test on the blood samples taken in visit 2, 4 and 6 to observe the oxidative profile of the patients with SLE before and after periodontal treatment.
  • To measure the effect of Periodontal Treatment on skin lesions in a population of patients suffering from SLE and PD. [ Time Frame: 2 years ]
    30 SLE patients will undergo OCT (Optical coherence tomography) investigation. SLE patients might have skin lesion as an immune destructive response by the cells. OCT will observe the skin lesions caused by the disease (SLE) in visit 2, 4 and 6 (before and after periodontal treatment)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Periodontal Disease in Systemic Lupus Erythematosus
Official Title  ICMJE Treatment of Periodontal Disease in Systemic Lupus Erytematosus: A Pilot Randomized Controlled Clinical Trial
Brief 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 Systemic lupus erythematosus (SLE) and Periodontitis (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 PD. The study which will take place in two centers 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 orthopantomogram (OPG), Comprehensive periodontal examination recording, Blood samples collection vascular function assessment and optical coherence tomography (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, Alogrithm for cardiovascular disease (Qrisk3) questionnaire (Visit 3 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.
Detailed Description

This study is a pilot trial that will take place in a multi-center where participants will be randomly allocated to one of two groups (control and test group). Each participant in test group will attend 7 visits (screening, baseline, periodontal treatment visit (Visit 3a and 3b), 2-month follow-up, second periodontal treatment and 6-months Follow-up visit). In the control group each participant will attend 6 visits (Screening, baseline, periodontal treatment visit, 2-months follow-up visit, second periodontal treatment visit and 6-months follow-up). The study will recruit 15 participants per group (30 participants total). Potential participants will be provided with an information sheet (if interested) will attend a screening visit to confirm eligibility for inclusion in the study. Written informed consent will be obtained and the baseline visit will be scheduled. Following enrollment, the study will require attendance at 6 visits for the control and 7 visits (visit 3a and 3b) for test groups. Participant would be asked at screening and blood would be collected on the same day of the Baseline Visit and Flow mediated dilatation (FMD) will also take place at the baseline visit. Below is a summary of measures and procedures that will take place at each visit:

Visit 1 Screening Visit - Day 0 (30 minutes): Potential participants will have the opportunity to ask questions to the study staff. If they wish to take part, participants will be asked to sign three copies of the consent form. One copy will be kept by the research centre and the other copy, along with a copy of the information sheet, will be given to them and the third copy of the consent form will be kept in the medical records. Investigator will ask some questions about their medical history and examine their mouth to confirm eligibility for participation in this study. Any changes in their health history will be noted in each visit. Height, weight, and blood pressure will be measured. In visit 2 there will be a sample of their blood and saliva/plaque and will be collected in three of the visits OPG and OCT will be done in the 2nd visit. Following this, a score of the amount of plaque on their teeth and some measurements of their gum health will be recorded. Visit 3 (a and b) will be assigned only for the test group in which they will be provided with the Intensive periodontal treatment (IPT). Control group will also undergo through (Control periodontal treatment/CPT) in their visit 3. Visit 4 will be a two-month follow-up for the test and the control group in which they will undergo from periodontal assessment, flow mediated dilatation, collection of blood samples and optical coherence tomography (OCT). Visit 5 is for the control and test group in which they will undergo the second periodontal treatment (IPT and CPT). 6-months follow up will consist of Flow mediated dilatation, periodontal assessment collection of blood samples and Optical coherence tomography (OCT) for both the groups. Study completion will take place after 6 months of the trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Total 30 Participants. Test group (n=15) control group (n=15)
Masking: Single (Outcomes Assessor)
Masking Description:
It is a single-blinded study in which cardio-vascular technician will be blinded.
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Periodontitis
Intervention  ICMJE
  • Procedure: supra/sub gingival root surface debridement
    The test group will undergo Intensive periodontal treatment (IPT)
    Other Name: IPT
  • Procedure: supra-gingival scaling and polishing
    Control group will receive the Control periodontal treatment (CPT).
    Other Name: CPT
Study Arms  ICMJE
  • Experimental: test group
    intensive periodontal treatment (IPT)
    Intervention: Procedure: supra/sub gingival root surface debridement
  • Sham Comparator: control group
    Control periodontal treatment (CPT)
    Intervention: Procedure: supra-gingival scaling and polishing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male/Female Subject must be 18 years of age or over.
  2. 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).
  3. Presence of moderate to severe periodontitis (at least 30 pockets with Probing depth equal or greater than 5mm).
  4. Subject must have voluntarily signed the informed consent.

Exclusion Criteria:

  1. Pregnancy or breastfeeding.
  2. Having fewer than 15 teeth.
  3. Subject knowingly has HIV or Hepatitis.
  4. Subject is not capable to give informed consent.
  5. Presence of concomitant rheumatoid arthritis, Sjogren syndrome, diabetes mellitus.
  6. Smoking.
  7. Subject on anticoagulants.
  8. Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
  9. Subjects who received periodontal treatment within 6 months from the baseline

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Syed Basit Hussain, BDS +447477024924 syed.hussain.16@ucl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04046172
Other Study ID Numbers  ICMJE 123436
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Francesco D`Aiuto, PhD Unit of Periodontology Eastman Dental Institute,UCL.
Principal Investigator: Coziana Ciurtin, PhD Department of Rheumatology, UCLH.
Study Chair: Marco Orlandi, PhD Unit of Periodontology Eastman Dental Institute,UCL.
Study Chair: Jacopo Buti, PhD Unit of Periodontology Eastman Dental Institute,UCL.
PRS Account University College, London
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP