[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643347":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":38,"studyPopulation":26,"armGroups":39,"interventions":52,"overallOfficials":26,"centralContacts":62,"locations":68,"responsibleParty":96,"collaborators":26,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":26,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":127,"whyStopped":26,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Universidad Catolica Santiago de Guayaquil","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Probing Pocket Depth (PPD)","Mean change in probing pocket depth (PPD), measured in millimeters using a UNC-15 periodontal probe, comparing baseline and 30-day follow-up between treatment groups.","Baseline and 30 Days",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change in Clinical Attachment Level (CAL)","Mean change in clinical attachment level (CAL), measured in millimeters from the cemento-enamel junction to the bottom of the periodontal pocket.",{"measure":18,"description":19,"timeFrame":12},"Change in Bleeding on Probing (BOP)","Percentage of sites presenting bleeding on probing after periodontal examination.",{"measure":21,"description":22,"timeFrame":12},"Change in Plaque Index (PI)","Percentage of dental surfaces with visible plaque assessed using the O'Leary plaque index.",{"measure":24,"description":25,"timeFrame":12},"Change in Gingival Index (GI)","Mean gingival index score assessed according to the Löe and Silness criteria.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","This is a randomized split-mouth clinical trial in which each participant receives both interventions. One hemiarch is randomly assigned to scaling and root planing (SRP) alone, while the contralateral hemiarch receives scaling and root planing combined with antimicrobial photodynamic therapy (aPDT). Clinical outcomes are compared between treatment conditions within the same participant.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"DOUBLE","Participants will not be informed which hemiarch receives adjunctive antimicrobial photodynamic therapy. Clinical measurements and outcome assessments will be performed by an examiner blinded to treatment allocation whenever possible.",[36,37],"PARTICIPANT","OUTCOMES_ASSESSOR","Periodontitis is a chronic inflammatory disease characterized by the destruction of the supporting tissues of the teeth and is one of the leading causes of tooth loss worldwide. Scaling and root planing (SRP) is considered the gold standard non-surgical treatment; however, complete elimination of periodontal pathogens may be difficult in deep periodontal pockets and anatomically complex sites.\n\nAntimicrobial photodynamic therapy (aPDT) has emerged as a minimally invasive adjunctive treatment. This technique combines a photosensitizing agent, toluidine blue O, with low-level laser irradiation to produce reactive oxygen species capable of destroying periodontal pathogens while minimizing damage to host tissues.\n\nThis study will be conducted at the Dental Clinic of the Universidad Católica de Santiago de Guayaquil, Ecuador. Thirty adult patients diagnosed with periodontitis will be enrolled. A split-mouth randomized design will be used, with one hemiarch receiving SRP alone (control) and the contralateral hemiarch receiving SRP plus aPDT (test group).\n\nClinical parameters including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI) will be recorded at baseline and at 30-day follow-up. The primary objective is to compare the clinical effectiveness of adjunctive aPDT versus conventional SRP alone in improving periodontal health outcomes.\n\nThe study has been approved by the Ethics Committee for Research in Human Subjects of the Universidad Católica de Santiago de Guayaquil (CEISH-UCSG) and will be conducted in accordance with ethical principles for human research.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Scaling and Root Planing (SRP)","ACTIVE_COMPARATOR","Hemiarch treated with conventional non-surgical periodontal therapy consisting of scaling and root planing alone.",[45],"Procedure: Scaling and Root Planing",{"label":47,"type":48,"description":49,"interventionNames":50},"Scaling and Root Planing Plus Antimicrobial Photodynamic Therapy (SRP + aPDT)","EXPERIMENTAL","Hemiarch treated with conventional scaling and root planing combined with adjunctive antimicrobial photodynamic therapy using toluidine blue O and low-level laser irradiation.",[45,51],"Procedure: Antimicrobial Photodynamic Therapy",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"PROCEDURE","Scaling and Root Planing","Conventional non-surgical periodontal therapy performed using ultrasonic and manual instrumentation to remove subgingival biofilm and calculus.",[41,47],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":26},"Antimicrobial Photodynamic Therapy","Adjunctive antimicrobial photodynamic therapy using toluidine blue O as photosensitizer activated with a 650 nm low-level laser following scaling and root planing.",[47],[63],{"name":64,"role":65,"phone":66,"phoneExt":26,"email":67},"GABRIELA G ZAMBRANO MANZABA, DDS","CONTACT","+19546298543","gabriela.zambrano06@cu.ucsg.edu.ec",[69],{"facility":70,"status":26,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Dental School, Catholic University of Santiago de Guayaquil (UCSG)","Guayaquil","Guayas","090101","Ecuador","EC",{"type":77,"coordinates":78},"Point",[79,80],-79.88621,-2.19616,{"lat":80,"lon":79},[83,86,88,91,94],{"name":64,"role":65,"phone":84,"phoneExt":26,"email":85},"9546298543","gabriela.manzaba30@gmail.com",{"name":87,"role":65,"phone":84,"phoneExt":26,"email":67},"GABRIELA ZAMBRANO MANZABA, DDS",{"name":89,"role":90,"phone":26,"phoneExt":26,"email":26},"PABLO M REYES CUENCA, DDS","SUB_INVESTIGATOR",{"name":92,"role":93,"phone":26,"phoneExt":26,"email":26},"GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS","PRINCIPAL_INVESTIGATOR",{"name":95,"role":90,"phone":26,"phoneExt":26,"email":26},"HECTOR A LEMA GUTIERREZ, DDS",{"type":93,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Gabriela Guadalupe Zambrano Manzaba","Principal Investigador","100643347","photodynamic-therapy-as-an-adjunct-in-periodontal-treatment-100643347",false,"NCT07633405","Photodynamic Therapy as an Adjunct in Periodontal Treatment","Clinical Evaluation of Photodynamic Therapy as an Adjunct to Scaling and Root Planing in the Treatment of Periodontal Disease: A Split-Mouth Randomized Controlled Clinical Trial","PDT-PERIO","Inclusion Criteria:\n\n* Adults aged 18 to 65 years.\n* Diagnosis of Stage I, II, III, or IV periodontitis according to the 2018 World Workshop Classification.\n* Presence of at least two hemiarches with periodontal pockets ≥5 mm suitable for a split-mouth design.\n* Systemically healthy individuals.\n* No periodontal treatment received within the previous 6 months.\n* No use of antibiotics, anti-inflammatory drugs, or antiseptic mouth rinses within the previous 3 months.\n* Ability and willingness to provide written informed consent and attend follow-up visits.\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases that may affect healing or immune response.\n* Use of antibiotics, corticosteroids, or immunosuppressive medications within the previous 3 months.\n* Active smokers consuming more than 10 cigarettes per day.\n* Pregnant or breastfeeding women.\n* Presence of dental implants, defective restorations, or teeth with Grade III mobility in the selected study sites.\n* Known allergy to toluidine blue O or any component of the photosensitizer.\n* Individuals unable or unwilling to attend the 30-day follow-up visit.","ALL","18 Years","65 Years",{"count":111,"type":112},30,"ESTIMATED","INTERVENTIONAL",[115],"NA","This study aims to evaluate the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunct to scaling and root planing (SRP) in the treatment of periodontitis. A split-mouth design will be used, in which one hemiarch receives conventional SRP and the contralateral hemiarch receives SRP combined with aPDT. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI), will be assessed at baseline and 30 days after treatment. The study seeks to determine whether adjunctive aPDT improves periodontal outcomes compared with conventional non-surgical periodontal therapy alone.",[118,119],"Periodontitis","Periodontal Disease",[118,119,59,121,122,123,124,125,126],"Photodynamic Therapy","aPDT","SRP","Clinical attachment level","Low level Laser therapy","Gingival Index","NOT_YET_RECRUITING","2026-06-02",{"date":130,"type":131},"2026-06-08","ACTUAL",{"date":133,"type":112},"2026-07-28",{"date":135,"type":112},"2026-09-27",{"name":5,"class":6},1]