[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631960":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":45,"armGroups":41,"interventions":46,"overallOfficials":41,"centralContacts":62,"locations":68,"responsibleParty":88,"collaborators":41,"id":92,"slug":41,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":41,"enrollmentInfo":101,"targetDuration":41,"studyType":104,"phases":41,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":70,"whyStopped":41,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Pisa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Pocket Closure","Percentage of affected sites (probing pocket depth ≥4 mm at baseline) that achieve a probing pocket depth \\\u003C4 mm","3 months and subsequent follow-ups",{"measure":14,"description":15,"timeFrame":12},"Periodontitis Patient Resolution","Number and percentage of participants showing no sites with PPD\\>5 mm at 3 months and subsequent re-evaluation",[17,20,23,26,29,32,35,38],{"measure":18,"description":19,"timeFrame":12},"Change in Probing Pocket Depth (PPD)","Change in mean PPD from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.",{"measure":21,"description":22,"timeFrame":12},"Change in Clinical Attachment Level (CAL)","Change in mean CAL from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.",{"measure":24,"description":25,"timeFrame":12},"Change in Full-Mouth Bleeding Score (FMBS)","Change in FMBS from baseline to 3 months and subsequent re-evaluation. FMBS is a periodontal index used to assess gingival inflammation by recording the presence or absence of bleeding on probing at multiple sites around all teeth. Common systems include the Ainamo and Bay (1975) method, using a 6-site per tooth recording (mesiobuccal, buccal, distobuccal, distolingual, lingual, mesiolingual).\n\nThe score is calculated as (number of bleeding sites \u002F total number of sites examined) × 100%. So a percentage. Interpretation: low scores (\\\u003C10% usually healthy), 10-30% mild inflammation, \\>30% significant inflammation. Clinical significance: high scores indicate poor oral hygiene, active gingivitis, risk for periodontitis progression, need for more frequent recall or scaling\u002Froot planing.",{"measure":27,"description":28,"timeFrame":12},"Change in Number of Deep Pockets","Change in the number of sites with PPD ≥5 mm and ≥6 mm from baseline to 3 months and subsequent re-evaluation. A decrease indicates periodontal condition improvement.",{"measure":30,"description":31,"timeFrame":12},"Gingivitis Patient Resolution","Description: Number of participants achieving a full-mouth bleeding score (FMBS) \\\u003C10%. FMBS is a periodontal index used to assess gingival inflammation by recording the presence or absence of bleeding on probing at multiple sites around all teeth. Common systems include the Ainamo and Bay (1975) method, using a 6-site per tooth recording (mesiobuccal, buccal, distobuccal, distolingual, lingual, mesiolingual). The score is calculated as (number of bleeding sites \u002F total number of sites examined) × 100%. So a percentage. Interpretation: low scores (\\\u003C10% usually healthy), 10-30% mild inflammation, \\>30% significant inflammation. Clinical significance: high scores indicate poor oral hygiene, active gingivitis, risk for periodontitis progression, need for more frequent recall or scaling\u002Froot planing.",{"measure":33,"description":34,"timeFrame":12},"Psychometric testing and Oral Health Related Quality of Life","Psychometric outcomes will be evaluated to assess the impact of the intervention on participants' perceived oral health and related quality of life. The Oral Health Impact Profile-14 (OHIP-14) will be administered as a secondary outcome measure at predefined study time points. This validated instrument captures functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap associated with oral conditions. Changes in OHIP-14 scores over time will be analyzed to determine the extent to which the intervention influences oral health-related quality of life.",{"measure":36,"description":37,"timeFrame":12},"Capillary blood sampling via finger prick","Capillary blood samples will be obtained via finger prick to measure C-reactive protein (CRP) and vitamin D levels. The procedure is minimally invasive and will be performed using a sterile, single-use lancet to obtain a small volume of blood. Samples will be analyzed using validated methods to assess inflammatory status (CRP) and vitamin D concentration.",{"measure":39,"description":40,"timeFrame":12},"Biologic fluid samples","Biologic fluid samples, including saliva and peripheral blood, will be collected from study participants to support exploratory and confirmatory analyses.",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","adult patients diagnosed with periodontitis",[47,53,57],{"type":48,"name":49,"description":50,"armGroupLabels":41,"otherNames":51},"PROCEDURE","Periodontal non surgical treatment","Non surgical periodontal therapy performed with ultrasonics and manual instruments. In patients affected by stages III-IV periodontitis, the adjunctive usage of wound healing enhancers will be applied in sites with PPD \\>5 mm.",[52],"Scaling and root planing",{"type":54,"name":55,"description":56,"armGroupLabels":41,"otherNames":41},"BEHAVIORAL","Oral Hygiene Instructions","Patients will be motivated and instructed to improve their daily home dental plaque control through the usage of interdental devices and electric toothbrush.",{"type":48,"name":58,"description":59,"armGroupLabels":41,"otherNames":60},"Surgical Periodontal Treatment","In some selected patients, whose periodontal defects will not heal despite consecutive non surgical interventions, periodontal surgical treatment, with or without regenerative devices, will be implemented.",[61],"periodontal surgery",[63],{"name":64,"role":65,"phone":66,"phoneExt":41,"email":67},"Filippo Graziani, Prof.","CONTACT","+393384014984","filippo.graziani@unipi.it",[69],{"facility":5,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"RECRUITING","Pisa","None Selected","56126","Italy","IT",{"type":77,"coordinates":78},"Point",[79,80],10.4036,43.70853,{"lat":80,"lon":79},[83,86],{"name":84,"role":65,"phone":41,"phoneExt":41,"email":85},"Filippo Graziani","filippograziani@med.unipi.it",{"name":41,"role":65,"phone":41,"phoneExt":41,"email":87},"rossana.izzetti@unipi.it",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Filippo Graziani, DDS MClinDent PhD","Full Professor, DMD, MClinDent, PhD","100631960",false,"NCT07507474","Performance of the Treatment of Periodontitis According to the Bioperio® Protocol","Performance of the Treatment of Periodontitis According to the Bioperio® Protocol: a Prospective Cohort Study","BIOPERIO","Inclusion Criteria:\n\n* Confirmed diagnosis of periodontitis (proximal attachment loss in ≥2 non-adjacent teeth)\n* No previous treatment for periodontitis\n* Systemically healthy or with well-controlled chronic medical conditions\n* Willingness to participate in the study and comply with the follow-up schedule\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Patients previously treated for periodontitis\n* Poorly controlled systemic conditions\n* Refusal to participate\n* Patients who did not complete the proposed treatment plan","ALL","18 Years",{"count":102,"type":103},5000,"ESTIMATED","OBSERVATIONAL","This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III\u002FIV cases-adjunctive enamel matrix derivative application in deep pockets.",[107],"Periodontitis",[109,110,111,112,113,114],"Enamel matrix proteins","dental scaling","root planing","oral hygiene","non-surgical periodontal therapy","periodontitis","2026-04-27",{"date":117,"type":118},"2026-05-01","ACTUAL",{"date":120,"type":118},"2023-12-05",{"date":122,"type":103},"2030-12-05",{"name":5,"class":6},1]