[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647362":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":30,"studyPopulation":19,"armGroups":31,"interventions":55,"overallOfficials":80,"centralContacts":92,"locations":101,"responsibleParty":122,"collaborators":19,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":19,"eligibilityCriteria":131,"healthyVolunteers":127,"sex":132,"minAge":133,"maxAge":19,"enrollmentInfo":134,"targetDuration":19,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":146,"overallStatus":103,"whyStopped":19,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Military Hospital of Tunis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Bleeding on Probing (BOP)","Bleeding on Probing (BOP) will be assessed within 15 seconds after gentle probing at six sites per tooth using a calibrated periodontal probe ( The instrument used (UNC-15 periodontal probe). The presence or absence of bleeding will be recorded and expressed as the percentage of bleeding sites per treatment quadrant. Measurements will be obtained by a blinded examiner at baseline, 3 months, and 6 months","Baseline, 3 months, and 6 months",{"measure":14,"description":15,"timeFrame":12},"Probing Pocket Depth (PPD)","Probing Pocket Depth (PPD) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual\u002Fpalatal, midlingual\u002Fpalatal, and distolingual\u002Fpalatal). Measurements will be performed by a calibrated examiner blinded to treatment allocation at baseline, 3 months, and 6 months.",{"measure":17,"description":18,"timeFrame":12},"Clinical Attachment Level (CAL)","Clinical Attachment Level (CAL) will be measured in millimeters using a calibrated UNC-15 periodontal probe at six sites per tooth by measuring the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket. Assessments will be performed by a blinded calibrated examiner at baseline, 3 months, and 6 months.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":25,"maskingDescription":19,"whoMasked":26},"TRIPLE",[27,28,29],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","The investigators hypothesize that while all adjuncts will improve results over SRP and saline irrigation , the biological group (I-PRF) will show the most significant gains in the Smoker Subgroup due to its ability to stimulate local angiogenesis and tissue repair in a traditionally poor healing environment.\n\n* By including smokers, this study addresses \"the down to reality \" challenge in dentistry. Smoking often impairs the blood supply to the gums; this trial investigates: if a biological approach like I-PRF (which introduces fresh growth factors) or a high-volume Antiseptic irrigation with Povidone-iodine, or a 980nm diode laser activation can overcome these healing barriers . The Key Research Goals: is to determine if the Biological group (I-PRF), which introduces high concentrations of growth factors and leukocytes, provides superior Probing Pocket Depth (PPD) reduction compared to an antiseptic group (Povidone-Iodine) and photobiomodulation group (diode laser activation).\n* The Smoking Factor:\n\nInvestigator will explore if the regenerative properties of I-PRF can overcome the compromised healing response typically found in the Smoking Subgroup.\n\n• Healing Quality: Investigator will identify which group shows the fastest reduction in inflammation, measured by Bleeding on Probing (BOP) and Clinical Attachment Level (CAL) gain.",[32,39,44,49],{"label":33,"type":34,"description":35,"interventionNames":36},"I-PRF","EXPERIMENTAL","Quadrants randomly assigned to receive I-PRF irrigation after SRP",[37,38],"Biological: Injectable Platelet-Rich Fibrin (I-PRF)","Procedure: Scaling and Root Planing",{"label":40,"type":34,"description":41,"interventionNames":42},"Povidone-Iodine","Quadrants randomly assigned to receive 1% povidone-iodine irrigation after SRP",[43,38],"Drug: Povidone-Iodine Irrigation (1%)",{"label":45,"type":34,"description":46,"interventionNames":47},"Diode Laser","Quadrants randomly assigned to receive diode laser activation after SRP",[48,38],"Device: Diode Laser Activation",{"label":50,"type":51,"description":52,"interventionNames":53},"Saline Control","SHAM_COMPARATOR","Quadrants randomly assigned to receive 0.9% saline irrigation after SRP",[54,38],"Procedure: Saline Irrigation (0.9%)",[56,61,66,71,76],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":19},"BIOLOGICAL","Injectable Platelet-Rich Fibrin (I-PRF)","Following scaling and root planing, periodontal pockets in the assigned quadrant will receive 5 mL of injectable platelet-rich fibrin (I-PRF) prepared at 60 G for 3 minutes",[33],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":19},"DEVICE","Diode Laser Activation","Following scaling and root planing, periodontal pockets in the assigned quadrant will receive adjunctive diode laser activation according to the study protocol",[45],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":19},"DRUG","Povidone-Iodine Irrigation (1%)","Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of 1% povidone iodine solution delivered using a blunt-tip cannula.",[40],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":19},"PROCEDURE","Saline Irrigation (0.9%)","Following scaling and root planing, periodontal pockets in the assigned quadrant will be irrigated with 5 mL of sterile 0.9% saline solution delivered using a blunt-tip cannula. This intervention serves as the control treatment for comparison with the adjunctive therapies.",[50],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":19},"Scaling and Root Planing","Conventional non surgical periodontal therapy consisting of supra and subgingival scaling and root planing performed using hand and ultrasonic instruments. All study quadrants will receive SRP before adjunctive treatment allocation.",[45,33,40,50],[81,85,88,90],{"name":82,"affiliation":83,"role":84},"Hela Jegham, DDS -Professor","Military Hospital of Instruction of Tunis","STUDY_DIRECTOR",{"name":86,"affiliation":83,"role":87},"hedi chouchene, DDS","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":83,"role":84},"Rym masmoudi, DDS - Associate Professor",{"name":91,"affiliation":83,"role":87},"yassmine rjeb, DDS",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":19,"email":97},"Hela Jegham, DDS - Professor","CONTACT","+21654241521","hela.jegham@yahoo.fr",{"name":86,"role":95,"phone":99,"phoneExt":19,"email":100},"+21652042177","chouchanehadi76@gmail.com",[102],{"facility":83,"status":103,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"RECRUITING","Tunis","Mont Fleury","1008","Tunisia","TN",{"type":110,"coordinates":111},"Point",[112,113],10.16579,36.81897,{"lat":113,"lon":112},[116,119,120],{"name":117,"role":95,"phone":118,"phoneExt":19,"email":97},"hela Jegham, DDS - Professor","+216 54 241 521",{"name":86,"role":87,"phone":19,"phoneExt":19,"email":19},{"name":121,"role":87,"phone":19,"phoneExt":19,"email":19},"yasmine rjab, DDS",{"type":87,"investigatorFullName":123,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Hela Jegham","Doctor of Dental Surgery - Professor at Military Hospital of Instruction of Tunis","100647362","phase-4-this-a-clinical-trial-to-evaluate-the-efficacy-of-i-prf-povidone-iodine-and-laser-as-adjuncts-to-non-surgical-periodontal-treatment-in-smokers-and-non-smokers-periodontitis-patients-100647362",false,"NCT07707063","This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients","Clinical Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients : A Split Mouth Randomized Clinical Trial","Inclusion: Patients with Stage II-IV Periodontitis; at least one bleeding pocket \\> 4 mm minimum in every quadrant.\n\nExclusion: patients who:\n\n* Pregnant \u002FLactating\n* History of radiotherapy or chemotherapy in the head\u002Fneck region.\n* Known hypersensitivity to Iodine or Methylene blue solution\n* Systematic antibiotic use within the last 30 days\n* Long-term use of immunosuppressants or corticosteroids (daily use)\n* type 1 \u002F 2 diabetes","ALL","18 Years",{"count":135,"type":136},50,"ESTIMATED","INTERVENTIONAL",[139],"PHASE4","This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP\u002FEFP periodontal classification.",[142,143,144,145],"Periodontitis","Smokers","Non Smokers","Periodontal Disease",[147,45,148,149,150,151,152],"Injectable platelet-rich fibrin (I-PRF)","iodine solution","Periodontal Pockets","periodontal debridement","lasers","Regenerative periodontal therapy","2026-07-10",{"date":155,"type":156},"2026-07-16","ACTUAL",{"date":158,"type":156},"2026-05-25",{"date":160,"type":136},"2027-05-18",{"name":5,"class":6},1]