Treatment of Periodontal Disease in Systemic Lupus Erythematosus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04046172|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
|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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|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|
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
- 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).
- 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)
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
|Contact: Syed Basit Hussain, BDSemail@example.com|
|Eastman clinical investigation centre (ECIC) Eastman Dental Institute.|
|London, United Kingdom, wc1 x8ld|
|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.|