[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654657":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":50,"studyPopulation":37,"armGroups":51,"interventions":64,"overallOfficials":37,"centralContacts":74,"locations":80,"responsibleParty":109,"collaborators":37,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":37,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":138,"whyStopped":37,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Colgate Palmolive","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Pocket depth (PD) reduction","The distance measured between the gingival margin and the bottom of the gingival sulcus or the periodontal pocket, assessed at six sites per tooth using a calibrated periodontal probe.","Baseline, 3 months, 6 months, 9 months, and 12 months post-treatment",[14,18,21,24,27,31,34],{"measure":15,"description":16,"timeFrame":17},"Change in Gingival Index (GI)","Evaluated using the Löe-Silness Gingival Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing gingival inflammation and bleeding.","Baseline, 3 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment",{"measure":19,"description":20,"timeFrame":17},"Change in Plaque Index (PI)","Evaluated using the Löe \\& Silness Plaque Index (score 0-3) on all scorable surfaces to determine a whole mouth mean score representing microbial plaque accumulation.",{"measure":22,"description":23,"timeFrame":12},"Clinical Attachment Level (CAL) gain","The distance measured between the cemento-enamel junction and the bottom of the gingival sulcus or periodontal pocket, assessed at six sites per tooth.",{"measure":25,"description":26,"timeFrame":12},"Change in Bleeding on Probing (BOP)","Evaluated using the Ainamo \\& Bay Index, scoring the presence or absence of bleeding in the gingival sulcus after gentle probing, expressed as a percentage of bleeding sites over total sites.",{"measure":28,"description":29,"timeFrame":30},"Number of residual pockets","The quantity of sites exhibiting residual pockets (PD \\>= 4 mm with bleeding on probing).","3 months, 6 months, 9 months, and 12 months post-treatment",{"measure":32,"description":33,"timeFrame":17},"Change in subgingival microbiological composition","Subgingival plaque collected via sterile curette and analyzed by qPCR to determine total and relative bacterial quantification.",{"measure":35,"description":36,"timeFrame":17},"Change in levels of immunological mediators in gingival crevicular fluid (GCF)","GCF collected via sterile paper strips and analyzed for host biomarkers using enzyme-linked immunosorbent assay (ELISA) techniques",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":44,"whoMasked":45},"QUADRUPLE","All products will be covered with white over-wrapping in order to conceal product identity. The examining dentist and their staff will remain blinded to product assignments.",[46,47,48,49],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a Phase III, multicenter, controlled, randomized, double-blind clinical trial with two parallel arms. A total of 100 participants, aged 30 to 70, diagnosed with stage II generalized periodontitis will undergo non-surgical periodontal treatment and be randomized to one of two at-home oral hygiene regimens. Participants will be monitored over a 12-month period to assess clinical periodontal parameters.",[52,58],{"label":53,"type":54,"description":55,"interventionNames":56},"Test Group","EXPERIMENTAL","Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen (Regimen I) consisting of a chlorhexidine mouthwash, stannous fluoride toothpaste, toothbrush, and floss for 3 weeks. Afterward, they switch to Regimen II consisting of a CPC\u002FZinc Lactate mouthwash, stannous fluoride toothpaste, toothbrush, and floss.",[57],"Combination Product: Active Oral Hygiene Regimen",{"label":59,"type":60,"description":61,"interventionNames":62},"Negative Control Group","PLACEBO_COMPARATOR","Participants receive non-surgical periodontal treatment followed by an adjunctive oral hygiene regimen consisting of a fluoride placebo mouthwash, standard fluoride toothpaste, toothbrush, and floss for the duration of the study.",[63],"Combination Product: Placebo Oral Hygiene Regimen",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":37},"COMBINATION_PRODUCT","Active Oral Hygiene Regimen","Participants use a 0.12% chlorhexidine mouthwash and stannous fluoride toothpaste for 3 weeks (Regimen I). Afterwards, they switch to a 0.09% CPC and 0.28% Zinc Lactate mouthwash with fluoride and stannous fluoride toothpaste (Regimen II). Both regimens include a soft bristle toothbrush and dental floss.",[53],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":37},"Placebo Oral Hygiene Regimen","Participants use a fluoride placebo mouthwash, standard fluoride toothpaste, soft bristle toothbrush, and dental floss for the duration of the study.",[59],[75],{"name":76,"role":77,"phone":78,"phoneExt":37,"email":79},"Cristina C Villar, PhD","CONTACT","+55 11 26488055","villar@usp.br",[81,99],{"facility":82,"status":37,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Federal University of Rio Grande do Sul","Porto Alegre","Rio Grande do Sul","90035-003","Brazil","BR",{"type":89,"coordinates":90},"Point",[91,92],-51.23019,-30.03283,{"lat":92,"lon":91},[95],{"name":96,"role":77,"phone":97,"phoneExt":37,"email":98},"Cassiano K Rosing, PhD","+55 51 99511 9123","ckrosing@hotmail.com",{"facility":100,"status":37,"city":101,"state":101,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"University of São Paulo, School of Dentistry","São Paulo",{"type":89,"coordinates":103},[104,105],-46.63611,-23.5475,{"lat":105,"lon":104},[108],{"name":76,"role":77,"phone":78,"phoneExt":37,"email":79},{"type":110,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100654657","phase-3-efficacy-of-oral-hygiene-regimens-in-patients-undergoing-non-surgical-periodontal-treatment-100654657",false,"NCT07803484","Efficacy of Oral Hygiene Regimens in Patients Undergoing Non-Surgical Periodontal Treatment","Efficacy of Multi-component Oral Hygiene Regimens in Patients Undergoing Non-surgical Periodontal Treatment: a Multicentered Randomized Clinical Trial.","PEREG","Inclusion Criteria:\n\n* Males and females, between 30-70 years of age, inclusive.\n* Good general health. Minimum of 15 uncrowned permanent natural teeth (excluding third molars and crowns).\n* Clinical diagnosis of stage II generalized periodontitis.\n\nExclusion Criteria:\n\n* Periodontal treatment undergone 3 months before the beginning of the study. - Mucosal oral pathology.\n* Uncontrolled systemic chronic disease that may interfere with host response. - Use of anti-inflammatory and antibiotic within 3 months prior to the start of the study, scheduled to start such intake during the treatment phase, or use of therapeutic mouthwash within the last three months.\n* Need for antibiotic prophylaxis.\n* Participation in any other clinical study.\n* Pregnant, breastfeeding, or intended to get pregnant during the study.\n* Allergic to oral care products, personal care consumer products, or their ingredients.\n* Ongoing use of medications known to affect the gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).\n* Current smokers and subjects with a history of alcohol or drug abuse. - Orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations.","ALL","30 Years","70 Years",{"count":123,"type":124},100,"ESTIMATED","INTERVENTIONAL",[127],"PHASE3","The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.",[130,131],"Periodontal Disease","Gingival Inflammation and Bleeding",[133,134,135,136,137],"Periodontitis","Oral hygiene","Non-surgical periodontal treatment","Mouthwashes","Toothpastes","NOT_YET_RECRUITING","2026-08-31",{"date":141,"type":142},"2026-09-03","ACTUAL",{"date":144,"type":124},"2026-09-01",{"date":146,"type":124},"2028-04-30",{"name":5,"class":6},2]