Nctid:
NCT06221137
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M4109", "name"=>"Anesthetics, Local", "relevance"=>"LOW"}, {"id"=>"M12472", "name"=>"Nickel", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2024-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-25", "studyFirstSubmitDate"=>"2023-07-11", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Stability of amount of healthy tooth structure exposed", "timeFrame"=>"8 weeks after retention.", "description"=>"Amount of healthy tooth structure exposed:\n\nThis is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the healthy tooth structure using UNC periodontal probe in millimeters."}], "secondaryOutcomes"=>[{"measure"=>"Stability of gingival Margin", "timeFrame"=>"8 weeks after retention.", "description"=>"This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the gingival margin using UNC periodontal probe in millimeters."}, {"measure"=>"Stability of the alveolar bone", "timeFrame"=>"8 weeks after retention.", "description"=>"This is measured from the 6 guide marks in the acrylic stent around the extruded teeth to the top of the alveolar crest using UNC periodontal probe in millimeters.\n\nThis is done after administration of local anesthesia by infiltration around the tooth"}, {"measure"=>"Rate of tooth extrusion", "timeFrame"=>"8 weeks after retention.", "description"=>"This is measured by calculating the average tooth extrusion per week by dividing the amount of healthy tooth structure exposed on the number of weeks."}, {"measure"=>"Sulcus depth", "timeFrame"=>"8 weeks after retention.", "description"=>"The distance from gingival margin to the base of the sulcus in millimetres."}, {"measure"=>"Post operative pain", "timeFrame"=>"8 weeks after retention.", "description"=>"VAS scale"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["fiberotomy", "extrusion", "crown lengthening"], "conditions"=>["Circumferential Supracrestal Fiberotomy", "Orthodontic Extrusion", "Crown Lengthening"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to the evaluate the stability of the amount of healthy tooth structure exposed after laser versus conventional technique of fiberotomy during orthodontic extrusion.", "detailedDescription"=>"Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.\n\nPICO:\n\nPopulation: patients with endodontically treated teeth and short clinical crown that require crown lengthening in the esthetic zone Intervention: laser fiberotomy with orthodontic extrusion Control: conventional fiberotomy using blade with orthodontic extrusion\n\nOutcomes:\n\nPrimary outcome: Stability of the mount of healthy tooth structure exposed.\n\nSecondary outcomes:\n\n* Stability of gingival Margin reference.\n* Stability of the alveolar bone.\n* Rate of tooth extrusion.\n* Sulcus depth.\n* Pain Time: 8 weeks after retention"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age between 18 and 50 years old\n* Teeth in the esthetic zone\n* Restorable teeth with successful endodontic treatment\n* Adjacent teeth with clinical attachment of at least two-thirds of the root length, thus permitting adequate support for orthodontic movement\n* Crown root ratio after extrusion of the needed ferrule amount not less than 1:1\n\nExclusion Criteria:\n\n* Patients with bad oral hygiene or Periodontally affected teeth\n* Uncontrolled diabetic patients\n* Pregnant females\n* Medications that could affect tooth movement (bisphosphonate) radiation therapy less than 2 years\n* Moderate-to-heavy daily smokers (who report consuming at least 11 cigarettes/day)\n* Teeth with periapical inflammation, ankylosis or vertical root fracture\n* Teeth with probability of furcation exposure after extrusion.\n* The level of the root is 3 mm or more apical to the level of the bone"}, "identificationModule"=>{"nctId"=>"NCT06221137", "briefTitle"=>"Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening: A Randomized Controlled Clinical Trial", "orgStudyIdInfo"=>{"id"=>"7-12-22"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"conventional circumferential supracrestal fiberotomy", "description"=>"* The amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022\"x0.028\" Roth prescription on piggyback for the tooth with (0.016\". x 0.022 \") stainless steel main arch wire and 0.0014\" nickel titanium auxiliary.\n\n • Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.\n* supracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006)", "interventionNames"=>["Procedure: conventional circumferential supracrestal fiberotomy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"laser circumferential supracrestal fiberotomy", "description"=>"* The amount of tooth that need to be extruded will be measured\n* Bonding brackets slot 0,022\"x0.028\" Roth prescription\n* piggyback for the tooth with (0.016\". x 0.022 \") stainless steel main arch wire and 0.0014\" nickel titanium auxiliary.\n\n • Fiberotomy\n* After 2 days of bonding, local anaesthetic solution will be administrated.\n* The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.\n* A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed.", "interventionNames"=>["Procedure: laser circumferential supracrestal fiberotomy"]}], "interventions"=>[{"name"=>"conventional circumferential supracrestal fiberotomy", "type"=>"PROCEDURE", "description"=>"The amount of tooth that need to be extruded will be measured Bonding brackets slot 0,022\"x0.028\" Roth prescription on piggyback for the tooth with (0.016\". x 0.022 \") stainless steel main arch wire and 0.0014\" nickel titanium auxiliary.\n\n• Fiberotomy After 2 days of bonding, local anaesthetic solution will be administrated. The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.\n\nsupracrustal fibrotomy will be performed using 15 c blade (Carvalho, Bauer et al. 2006)", "armGroupLabels"=>["conventional circumferential supracrestal fiberotomy"]}, {"name"=>"laser circumferential supracrestal fiberotomy", "type"=>"PROCEDURE", "description"=>"* The amount of tooth that need to be extruded will be measured\n* Bonding brackets slot 0,022\"x0.028\" Roth prescription\n* piggyback for the tooth with (0.016\". x 0.022 \") stainless steel main arch wire and 0.0014\" nickel titanium auxiliary.\n\n • Fiberotomy\n* After 2 days of bonding, local anaesthetic solution will be administrated.\n* The depth of the fibrotomy should be equal to the amount of tooth that need to be extruded.\n* A diode laser of 980 nm wavelength will be used The laser tip will be inserted, and incision will be extended around tooth circumference with the system configured to a continuous wave with the movement of the laser tip in an up and down stroking movement The laser tip will be moved in a circumferential manner taking care that all the fibers are lysed.", "armGroupLabels"=>["laser circumferential supracrestal fiberotomy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11553", "city"=>"Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Weam A El Battawy, PhD", "role"=>"CONTACT", "email"=>"Weamelbattawy@dentistry.cu.edu.eg", "phone"=>"01001500537", "phoneExt"=>"0020"}], "facility"=>"focality of dentistry Cairo university", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"roquaiya K Elgdardear, BDS", "role"=>"CONTACT", "email"=>"roquaiya.eldardear@dentistry.cu.edu.eg", "phone"=>"01014455789", "phoneExt"=>"0020"}, {"name"=>"Weam A El Battawy, PhD", "role"=>"CONTACT", "email"=>"Weamelbattawy@dentistry.cu.edu.eg", "phone"=>"01001500537", "phoneExt"=>"0020"}], "overallOfficials"=>[{"name"=>"Nesma M Shemais, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Cairo University"}, {"name"=>"Heba A Akl, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Cairo University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"roquaiya eldardear", "investigatorAffiliation"=>"Cairo University"}}}}
