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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

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Periodontitis Procedure: supra/sub gingival root surface debridement Procedure: supra-gingival scaling and polishing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Official Title: Treatment of Periodontal Disease in Systemic Lupus Erytematosus: A Pilot Randomized Controlled Clinical Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: test group
intensive periodontal treatment (IPT)
Procedure: supra/sub gingival root surface debridement
The test group will undergo Intensive periodontal treatment (IPT)
Other Name: IPT

Sham Comparator: control group
Control periodontal treatment (CPT)
Procedure: supra-gingival scaling and polishing
Control group will receive the Control periodontal treatment (CPT).
Other Name: CPT




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046172


Contacts
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Contact: Syed Basit Hussain, BDS +447477024924 syed.hussain.16@ucl.ac.uk

Locations
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United Kingdom
Eastman clinical investigation centre (ECIC) Eastman Dental Institute.
London, United Kingdom, wc1 x8ld
Sponsors and Collaborators
University College, London
Investigators
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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.

Publications:

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04046172     History of Changes
Other Study ID Numbers: 123436
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Periodontitis
SLE
Lupus
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Lupus Erythematosus, Systemic
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases