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Systemic Lupus ErythematosusNCT04046172

Treatment of Periodontal Disease in Systemic Lupus Erythematosus

A study testing supra/sub gingival root surface debridement and supra-gingival scaling and polishing in people with Systemic Lupus Erythematosus and Periodontitis, run by University College, London at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus, Periodontitis
What is being tested?
supra/sub gingival root surface debridement and supra-gingival scaling and polishing
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteUnited Kingdom
Study dates
1 Nov 2021to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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
  • -

Trial locations and contacts

1 site in 1 country.

Syed Basit Hussain, BDS contact

+447477024924

syed.hussain.16@ucl.ac.uk

United Kingdom1 site

  • Eastman clinical investigation centre (ECIC) Eastman Dental Institute.

    London, wc1 x8ld

Other trials in United Kingdom

About this study

Official title: Treatment of Periodontal Disease in Systemic Lupus Erytematosus: A Pilot Randomized Controlled Clinical Trial

The primary objective of this study is to:

Part 1 - Baseline Comparisons

Read more

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.

Read the detailed description

The primary endpoints of this study are in two parts. One part is to quantify the vascular health in response to PD as a static point prior to active therapy compared to participants with SLE and healthy perdiodontium . The second part is to quantify and compare the clinical and systemic outcomes of cases with SLE and PD following periodontalal treamtment.

Part 1 Comparative analyses between cases (SLE with PD) and controls (SLE without PD) will be performed using ANOVA analysis. Primary outcome will be the difference in flow -mediated dilatation between groups. Multivariate analysis will be performed to adjust for a number of covariates including: age, gender, body mass index, ethnicity and supragingival plaque levels.

All secondary endpoints will be analysed with ANOVA. Pre-specified analyses of secondary outcomes will include descriptive analyses and differences.

Part 2 Primary clinical periodontal outcome will be the difference in mean flow mediated (peri-implant) at 6 months between study groups and analysed by analysis of co-variance model. Age, gender, body mass index, smoking status, ethnicity and dental plaque levels will be included as additional covariates. Pair-wise comparison and between groups differences will be calculated using Tukey HSD corrections. If the normality assumption does not seem reasonable even after transformation of original values, equivalent nonparametric methods will be used.

Primary systemic inflammatory outcome will be

Changes in FMD (primary outcome), circulating inflammatory, vascular and oxidative biomarkers (secondary outcomes) will be analysed with analysis of variance for repeated measures using a conservative F-test (Greenhouse-Geisser correction). If a treatment by time interaction will be found, pair-wise comparisons will be performed (Bonferroni-Holm adjustment). Side effects and safety data will be summarized using standard descriptive statistics. Significance will be set to be at p < 0.05.

Experimental Design

Participants will be approached by the members of healthcare research team explaining the possibilities to be included in the project. There will be limit in time (24 Hours) to decide whether participate, subject to the recruitment completion.. A sufficient number of participants meeting the necessary inclusion/exclusion criteria will be accepted for the study in order to recruit 30 patients suffering from SLE and PD. Participants who consent to this study will undergo a baseline visit (Sample size 200) in which they will have a comprehensive full mouth periodontal probing depths assessment. In addition, full mouth plaque and gingival bleeding scores will also be calculated. A series of parameters will be recorded (including age, gender, ethnicity, and body mass index). Saliva samples (1 ml) and Blood samples (32 ml) will also be collected for analysis of peripheral blood inflammatory and oxidative biomarkers. Blood cell counts, C-reactive protein, complement levels, dsDNA autoantibodies, kidney and liver function tests will also be performed. The vascular function will be assessed by means of an ultrasound scan. After randomization (selected 30 patients) to either Test or Control Group, the test group will undergo periodontal treatment in 2 sessions within a week from each other. Radiographic examination Orthopentomogram (OPG) will be taken at the second visit of patient's visit only. Optical coherence tomography will be done on the patients in vist (2,4 and 6). At 2 months both groups will be reassessed, and the same information and samples taken at baseline will be collected. The test group will undergo additional periodontal treatment visit (3) of Intensive periodontal treatment/IPT) within 3 weeks from the 2 months visit. After this visit the Control group will receive the same periodontal treatment (Control periodontal treatment/CPT). At 6 months both groups will be seen for the final study assessment. If at any of the study assessment (2 months and 6 months) participants in the control group show signs of progression of PD they will be treated separately and exited from the trial. After 6 months all the participants will have treatment irrespective of groups, if they require treatment it will provided

Being tested
supra/sub gingival root surface debridement, supra-gingival scaling and polishing
Keywords
Periodontitis, SLE, Lupus
Medical subject headings
Lupus Erythematosus, Systemic, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • supra/sub gingival root surface debridementProcedure or surgery

    Also called IPT

    The test group will undergo Intensive periodontal treatment (IPT)

  • supra-gingival scaling and polishingProcedure or surgery

    Also called CPT

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

Study groups in NCT04046172
Study groupRoleWhat they receive
test groupExperimentalintensive periodontal treatment (IPT)
Receives: Procedure: supra/sub gingival root surface debridement
control groupSham comparatorControl periodontal treatment (CPT)
Receives: Procedure: supra-gingival scaling and polishing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 years

Secondary outcomes (4)

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

    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.

    Measured: 2 years

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

    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.

    Measured: 2 Years

  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.

    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.

    Measured: 2 years

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

    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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Total 200 Participants for part 1 (baseline). Randomization (Part 2) Control Test group (n=15) control group (n=15)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046172
Sponsor's protocol ID
123436
Status last verified
Oct 2021
First submitted
15 Jul 2019
Last updated
12 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jacobsen S, Petersen J, Ullman S, Junker P, Voss A, Rasmussen JM, Tarp U, Poulsen LH, van Overeem Hansen G, Skaarup B, Hansen TM, Podenphant J, Halberg P. A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value. Clin Rheumatol. 1998;17(6):478-84. doi: 10.1007/BF01451283.

    PubMed 9890675

  • Bartels CM, Buhr KA, Goldberg JW, Bell CL, Visekruna M, Nekkanti S, Greenlee RT. Mortality and cardiovascular burden of systemic lupus erythematosus in a US population-based cohort. J Rheumatol. 2014 Apr;41(4):680-7. doi: 10.3899/jrheum.130874. Epub 2014 Feb 15.

    PubMed 24532834

  • Urowitz MB, Bookman AA, Koehler BE, Gordon DA, Smythe HA, Ogryzlo MA. The bimodal mortality pattern of systemic lupus erythematosus. Am J Med. 1976 Feb;60(2):221-5. doi: 10.1016/0002-9343(76)90431-9.

    PubMed 1251849

  • Cervera R, Khamashta MA, Font J, Sebastiani GD, Gil A, Lavilla P, Mejia JC, Aydintug AO, Chwalinska-Sadowska H, de Ramon E, Fernandez-Nebro A, Galeazzi M, Valen M, Mathieu A, Houssiau F, Caro N, Alba P, Ramos-Casals M, Ingelmo M, Hughes GR; European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine (Baltimore). 2003 Sep;82(5):299-308. doi: 10.1097/01.md.0000091181.93122.55.

    PubMed 14530779

  • Doria A, Iaccarino L, Ghirardello A, Zampieri S, Arienti S, Sarzi-Puttini P, Atzeni F, Piccoli A, Todesco S. Long-term prognosis and causes of death in systemic lupus erythematosus. Am J Med. 2006 Aug;119(8):700-6. doi: 10.1016/j.amjmed.2005.11.034.

    PubMed 16887417

  • Manzi S, Meilahn EN, Rairie JE, Conte CG, Medsger TA Jr, Jansen-McWilliams L, D'Agostino RB, Kuller LH. Age-specific incidence rates of myocardial infarction and angina in women with systemic lupus erythematosus: comparison with the Framingham Study. Am J Epidemiol. 1997 Mar 1;145(5):408-15. doi: 10.1093/oxfordjournals.aje.a009122.

    PubMed 9048514

  • Skamra C, Ramsey-Goldman R. Management of cardiovascular complications in systemic lupus erythematosus. Int J Clin Rheumtol. 2010 Feb 1;5(1):75-100. doi: 10.2217/ijr.09.73.

    PubMed 20305727

  • Bruce IN, Gladman DD, Urowitz MB. Premature atherosclerosis in systemic lupus erythematosus. Rheum Dis Clin North Am. 2000 May;26(2):257-78. doi: 10.1016/s0889-857x(05)70138-1.

    PubMed 10768212

  • Salmon JE, Roman MJ. Accelerated atherosclerosis in systemic lupus erythematosus: implications for patient management. Curr Opin Rheumatol. 2001 Sep;13(5):341-4. doi: 10.1097/00002281-200109000-00001.

    PubMed 11604586

  • Asanuma Y, Oeser A, Shintani AK, Turner E, Olsen N, Fazio S, Linton MF, Raggi P, Stein CM. Premature coronary-artery atherosclerosis in systemic lupus erythematosus. N Engl J Med. 2003 Dec 18;349(25):2407-15. doi: 10.1056/NEJMoa035611.

    PubMed 14681506

  • Doria A, Shoenfeld Y, Wu R, Gambari PF, Puato M, Ghirardello A, Gilburd B, Corbanese S, Patnaik M, Zampieri S, Peter JB, Favaretto E, Iaccarino L, Sherer Y, Todesco S, Pauletto P. Risk factors for subclinical atherosclerosis in a prospective cohort of patients with systemic lupus erythematosus. Ann Rheum Dis. 2003 Nov;62(11):1071-7. doi: 10.1136/ard.62.11.1071.

    PubMed 14583570

  • Korkmaz H, Onalan O. Evaluation of endothelial dysfunction: flow-mediated dilation. Endothelium. 2008 Jul-Aug;15(4):157-63. doi: 10.1080/10623320802228872.

    PubMed 18663619

  • Inoue T, Node K. Vascular failure: A new clinical entity for vascular disease. J Hypertens. 2006 Nov;24(11):2121-30. doi: 10.1097/01.hjh.0000249684.76296.4f.

    PubMed 17053528

  • Halcox JP, Schenke WH, Zalos G, Mincemoyer R, Prasad A, Waclawiw MA, Nour KR, Quyyumi AA. Prognostic value of coronary vascular endothelial dysfunction. Circulation. 2002 Aug 6;106(6):653-8. doi: 10.1161/01.cir.0000025404.78001.d8.

    PubMed 12163423

  • Matsuzawa Y, Lerman A. Endothelial dysfunction and coronary artery disease: assessment, prognosis, and treatment. Coron Artery Dis. 2014 Dec;25(8):713-24. doi: 10.1097/MCA.0000000000000178.

    PubMed 25365643

Questions about this trial

What is this clinical trial studying?

A study testing supra/sub gingival root surface debridement and supra-gingival scaling and polishing in people with Systemic Lupus Erythematosus and Periodontitis, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Syed Basit Hussain, BDS (+447477024924, syed.hussain.16@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure the effect of periodontal treatment on SLE patients (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04046172, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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