Treatment of Periodontal Disease in Systemic Lupus Erythematosus
NCT ID: NCT04046172
Last Updated: 2021-10-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-11-01
Study Completion Date
2023-06-01
Brief Summary
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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.
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.
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Detailed Description
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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
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
Conditions
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Systemic Lupus Erythematosus
Periodontitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Total 200 Participants for part 1 (baseline). Randomization (Part 2) Control Test group (n=15) control group (n=15)
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
It is a single-blinded study in which cardio-vascular technician will be blinded.
Study Groups
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test group
intensive periodontal treatment (IPT)
Group Type
EXPERIMENTAL
supra/sub gingival root surface debridement
Intervention Type
PROCEDURE
The test group will undergo Intensive periodontal treatment (IPT)
control group
Control periodontal treatment (CPT)
Group Type
SHAM_COMPARATOR
supra-gingival scaling and polishing
Intervention Type
PROCEDURE
Control group will receive the Control periodontal treatment (CPT).
Interventions
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supra/sub gingival root surface debridement
The test group will undergo Intensive periodontal treatment (IPT)
Intervention Type
PROCEDURE
supra-gingival scaling and polishing
Control group will receive the Control periodontal treatment (CPT).
Intervention Type
PROCEDURE
Other Intervention Names
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IPT
CPT
Eligibility Criteria
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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.
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
\-
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
\-
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University College, London
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Francesco D'Aiuto, PhD
Role: STUDY_CHAIR
Unit of Periodontology Eastman Dental Institute,UCL.
Coziana Ciurtin, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology, UCLH.
Marco Orlandi, PhD
Role: STUDY_CHAIR
Unit of Periodontology Eastman Dental Institute,UCL.
Jacopo Buti, PhD
Role: STUDY_CHAIR
Unit of Periodontology Eastman Dental Institute,UCL.
Locations
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Eastman clinical investigation centre (ECIC) Eastman Dental Institute.
London, , United Kingdom
Site Status
Countries
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United Kingdom
Central Contacts
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References
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Other Identifiers
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123436
Identifier Type: -
Identifier Source: org_study_id
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