Nctid:
NCT06225154
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010518", "term"=>"Periodontitis"}, {"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000010510", "term"=>"Periodontal Diseases"}, {"id"=>"D000009059", "term"=>"Mouth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Diabetes Mellitus, Type 2", "relevance"=>"HIGH"}, {"id"=>"M13427", "name"=>"Periodontitis", "asFound"=>"Periodontitis", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes Mellitus", "relevance"=>"HIGH"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M13419", "name"=>"Periodontal Diseases", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2015-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2016-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2018-02-01", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2016-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Probing Depth (mm)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"probing depth measured from the gingival margin seldom corresponds to sulcus or pocket depth in mm."}, {"measure"=>"Plaque Index", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"The measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth. Values 0,1,2 and 3 can be taken. While 0 indicates the least value, 3 indicates the maximum value."}, {"measure"=>"Gingival Index", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"A measure of periodontal disease based on the severity and location of the lesion. Values 0,1,2 and 3 can be taken. While 0 indicates the least value, 3 indicates the maximum value."}, {"measure"=>"Bleeding on Probing (%)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Percentage of bleeding sites. Bleeding on probing, often abbreviated BOP, is a sign of inflammation and indicates some sort of destruction and erosion to the lining of the sulcus or the ulceration of sulcular epithelium. The blood comes from lamina propria after the ulceration of the lining."}, {"measure"=>"Clinical Attachment Level (mm)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"The estimated position of structures that support the tooth as measured with a periodontal probe in mm; provides an estimate of a tooth's stability and of loss of bone support."}], "primaryOutcomes"=>[{"measure"=>"Serum and Salivary Resistin Levels (pg/ml)", "timeFrame"=>"Change between baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Serum and salivary resistin levels"}, {"measure"=>"Serum and Salivary Leptin Levels (pg/ml)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Serum and salivary leptin levels"}, {"measure"=>"Serum and Salivary Visfatin Levels (pg/ml)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Serum and salivary visfatin levels"}, {"measure"=>"Serum and saliva IL-1β levels (pg/ml)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Serum and salivary IL-1β levels"}], "secondaryOutcomes"=>[{"measure"=>"HbA1c ( %)", "timeFrame"=>"Change baseline, 1 and 3 months after non-surgical periodontal treatment", "description"=>"Glycated Hemoglobin Level %"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["adipokines", "diabetes mellitus", "inflammation", "periodontitis"], "conditions"=>["Periodontitis", "Diabetes Mellitus, Type 2"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18565135", "type"=>"BACKGROUND", "citation"=>"Furugen R, Hayashida H, Yamaguchi N, Yoshihara A, Ogawa H, Miyazaki H, Saito T. The relationship between periodontal condition and serum levels of resistin and adiponectin in elderly Japanese. J Periodontal Res. 2008 Oct;43(5):556-62. doi: 10.1111/j.1600-0765.2008.01085.x. Epub 2008 Jun 28."}, {"pmid"=>"23805816", "type"=>"BACKGROUND", "citation"=>"Gokhale NH, Acharya AB, Patil VS, Trivedi DJ, Setty S, Thakur SL. Resistin levels in gingival crevicular fluid of patients with chronic periodontitis and type 2 diabetes mellitus. J Periodontol. 2014 Apr;85(4):610-7. doi: 10.1902/jop.2013.130092. Epub 2013 Jun 27."}, {"pmid"=>"25858047", "type"=>"BACKGROUND", "citation"=>"Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30."}]}, "descriptionModule"=>{"briefSummary"=>"The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM).", "detailedDescription"=>"The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT) on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were included in this study. At baseline, serum and saliva samples were collected and the whole mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in 4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3 months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate statistical tests."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"20 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diabetes mellitus should be diagnosed for ≥1 year and HbA1c level should be at least %6,5\n* Periodontitis should be diagnosed for at least 4 teeth with probing depth ≥5 mm with bleeding on probing (BOP) and also radiographic alveolar bone loss should be presence\n* Presence of at least 15 teeth\n\nExclusion Criteria:\n\n* Received antibiotic treatment in the previous 3 months\n* Smokers\n* Pregnancy and lactation\n* Received periodontal treatment in the previous 6 months\n* Presence of less than 15 teeth\n* Having major diabetic complications"}, "identificationModule"=>{"nctId"=>"NCT06225154", "briefTitle"=>"Effect of Periodontal Treatment on Adipokine Levels", "organization"=>{"class"=>"OTHER", "fullName"=>"Marmara University"}, "officialTitle"=>"Effect of Non-Surgical Periodontal Treatment on Adipokine Levels in Diabetes Mellitus: A Controlled Clinical Trial", "orgStudyIdInfo"=>{"id"=>"SAG-C-DRP-100216-0041"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"No intervention", "description"=>"Periodontally healthy subjects with type 2 diabetes mellitus or systemically healthy didn't have an initial periodontal treatment"}, {"type"=>"EXPERIMENTAL", "label"=>"Non-surgical periodontal treatment", "description"=>"Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals for periodontitis patients systemically healthy or with type 2 diabetes mellitus.", "interventionNames"=>["Procedure: Non-surgical periodontal treatment"]}], "interventions"=>[{"name"=>"Non-surgical periodontal treatment", "type"=>"PROCEDURE", "description"=>"Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.", "armGroupLabels"=>["Non-surgical periodontal treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"FI-20520", "city"=>"Turku", "state"=>"Lemminkäisenkatu 2", "country"=>"Finland", "facility"=>"Department of Periodontology, Institute of Dentistry, Turku University", "geoPoint"=>{"lat"=>60.45148, "lon"=>22.26869}}, {"zip"=>"34854", "city"=>"İstanbul", "state"=>"Maltepe", "country"=>"Turkey", "facility"=>"Marmara University, Faculty of Dentistry, Department of Periodontology", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}], "overallOfficials"=>[{"name"=>"Basak Dogan, Prof. Dr.", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Department of Periodontology, Faculty of Dentistry, Marmara University"}, {"name"=>"Yaprak Kalkan, Dt.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Department of Periodontology, Institute of Health Sciences, Marmara University"}, {"name"=>"Ulvi Kahraman Gürsoy, Assoc. Prof.", "role"=>"STUDY_CHAIR", "affiliation"=>"Department of Periodontology, Institute of Dentistry, Turku University"}, {"name"=>"Mervi Gürsoy, Assoc. Prof.", "role"=>"STUDY_CHAIR", "affiliation"=>"Department of Periodontology, Institute of Dentistry, Turku University"}, {"name"=>"Eija Könönen, Prof. Dr.", "role"=>"STUDY_CHAIR", "affiliation"=>"Department of Periodontology, Institute of Dentistry, Turku University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Marmara University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of Turku", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
