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IRCT20151013024509N4 IRCT 2021-03-23 Yazd University of Medical Sciences Evaluating the effect of non surgical periodontal treatment on the severity of systemic lupus erythematosus Evaluating the effect of non surgical periodontal treatment on the severity of systemic lupus erythematosus in patients referred to the Department of Rheumatology of Shahid Sadoughi and Rahnemon Hospitals 2021-03-21 anticipated 90 Complete https://irct.ir/trial/54811 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization Patients will be divided into control and intervention groups using simple random allocation method and random number table. Randomization tool: Through the website https://www.graphpad.com/quickcalcs/randomize1/, the total sample size is 90 people who were randomly divided into two groups of 45 people and a random table was provided to the researcher and based on it. The control and intervention group is determined. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process and will not have the authority to change or predict the status of individuals, Blinding description: The person evaluating the activity index of lupus erythematosus is not aware of the allocation of patients to intervention and control groups. N/A Systemic lupus erythematosus. Intervention 1: Intervention group: 45 patients with moderate to severe chronic periodontitis, at the beginning of the intervention, complete periodontal examinations, scaling and smoothing of root surfaces, Bass technique toothbrushing training with a dental model and a dental model in 10 minutes, registration Laboratory data of acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR) and evaluation and recording of systemic lupus erythematosus activity index with Q * MD software, three months later examination and re-registration of the mentioned information. Intervention 2: Control group: The control group includes patients who are only trained in brushing with Bass technique by lecture method and with a dental model for 10 minutes. Yes - There is a plan to make this available What will be shared: Accurate data collection method: In this study, periodontal status and severity of systemic lupus erythematosus for each patient at the beginning and after three months of treatment are evaluated based on the following clinical and laboratory parameters: Envelope depth, Clinical Attachment loss , bleeding index and plaque. Evaluation of systemic lupus erythematosus disease activity index and acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR) Data analysis method: After collecting the data, we encode them and enter them into the computer and are paired using SPSS 23 software and T-Tset tests and their independent or non-parametric equivalent and chi-square test and test. Fisher's exact results are analyzed. When: After collecting and analyzing data To whom: Executors of research projects Conditions: If periodontal treatments affect the severity of SLE, because by providing effective solutions to improve oral health and more emphasis on hygiene, we can reduce the severity of SLE and impose heavier costs on the disease materially and Spiritual (qualitative) prevented. Where to obtain: Executors of research projectsدر How to obtain: Requesting data requires the written consent of all research project implementers. Comments:
public Fahimeh Rashidi
Deh Fajr Street
Yazd Iran (Islamic Republic of) 8914881167 +98 35 1724 9333 f-rashidi63@ssu.ac.ir Yazd University of Medical Sciences scientific Kimiya Sezavar
Deh Fajr Street
Yazd Iran (Islamic Republic of) 8914881167 +98 35 1724 9333 k.sezavar@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive confirmation of systemic lupus erythematosus by a fellow rheumatologist and the condition of the disease is controlled Confirmation of moderate to severe generalized chronic periodontitis Have at least 20 teeth There is no evidence of heart valve involvement, congenital disorder, or a history of previous endocarditis requiring antibiotic prophylaxis. The patient's dose of corticosteroids should be below 20 mg of hydrocortisone or its equivalent A recent blood test is available based on the patient's neutrophil count above 1000 Evaluation of coagulation factors in case of thrombocytopenia in the patient's blood test Not taking aspirin and anticoagulants in the last month Do not take any antibiotics for 3 months before the start of the study Do not take a cytotoxic drug such as cyclophosphamide in the last month Non-long-term use of drugs affecting periodontal status (anticonvulsants, calcium channel blockers, etc.) during the 3 months before the start of the study Complete the consent form no limit no limit Both Having another systemic disease such as primary Sjogren's syndrome, diabetes, cardiovascular disease, history of radiation therapy or chemotherapy Antiphospholipid syndrome Pregnancy in a recent year History of periodontal treatment in the last 6 months Smoking M32.9 Systemic lupus erythematosus, unspecified Treatment - Other Prevention Intervention group: 45 patients with moderate to severe chronic periodontitis, at the beginning of the intervention, complete periodontal examinations, scaling and smoothing of root surfaces, Bass technique toothbrushing training with a dental model and a dental model in 10 minutes, registration Laboratory data of acute phase reactive protein (CRP) and erythrocyte sedimentation rate (ESR) and evaluation and recording of systemic lupus erythematosus activity index with Q * MD software, three months later examination and re-registration of the mentioned information. Control group: The control group includes patients who are only trained in brushing with Bass technique by lecture method and with a dental model for 10 minutes. Probing depth. Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: With Williams Probe. Clinical attachment loss. Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: With Williams Probe. Bleeding index. Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: Percentage of bleeding around the entire teeth after 30 seconds after probing. Plaque index. Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: Percentage of plaque accumulation around tooth surfaces after evaluation with a disclosingagent. Systemic lupus erythematosus disease activity index. Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: Numerically from 0 to 105 with Q * MD software. C-Reactive protein (CRP). Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: Record patient test information. Erythrocyte Sedimentation Rate (ESR). Timepoint: At the beginning of the study (before the intervention) and 3 months after the start of the study. Method of measurement: Record patient test information. Yazd University of Medical Sciences Approved 2019-06-25 Shahid Sadoughi University of Medical Sciences, Yazd Shahid Bahonar Square Yazd Yazd Iran (Islamic Republic of)