[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657568":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":33,"interventions":46,"overallOfficials":22,"centralContacts":56,"locations":62,"responsibleParty":79,"collaborators":22,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":22,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":22,"enrollmentInfo":91,"targetDuration":22,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":106,"whyStopped":22,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Probing pocket depth (PPD)","The distance measured from the gingival margin to the base of the periodontal pocket. This will be assessed at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) using a standardised UNC-15 periodontal probe exerted with approximately 0.25 N of probing force. It will be recorded in millimetres.","Will be measured at: Baseline, at 6-weeks, at 3-months and at 6-months review",{"measure":14,"description":15,"timeFrame":12},"Clinical Attachment Level (CAL)","The distance measured from a fixed anatomical reference point, the cementoenamel junction (CEJ), to the base of the periodontal pocket. It is calculated using the formula: CAL = PPD + Gingival Recession (or PPD - Gingival Overgrowth). It will be measured at the same six sites per tooth using a standardised UNC-15 probe. It will also be recorded in millimetres.",[17,20],{"measure":18,"description":19,"timeFrame":12},"Bleeding on Probing (BOP)","The presence or absence of provocative capillary bleeding within the sulcus following pocket instrumentation. It will be recorded as a binary outcome (\"Yes\" if bleeding occurs within 10 seconds of probing, \"No\" if no bleeding occurs) according to Ainamo \\& Bay's Bleeding Index at the evaluated pocket sites (Ainamo \\& Bay, 1975).",{"measure":21,"description":22,"timeFrame":12},"Plaque Score",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":29},"TRIPLE",[30,31,32],"CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Control Group","ACTIVE_COMPARATOR","This study will involve 2 arms in every patient since it will be a split-mouth study. The first arm (control site) will involve standard treatment (scaling and root debridement) for periodontitis.",[39],"Other: No intervention",{"label":41,"type":42,"description":43,"interventionNames":44},"Test Group","EXPERIMENTAL","This study will involve 2 arms in every patient since it will be a split-mouth study. The test arm is the second arm in the same patient but at a different tooth site (test site) which will receive standard treatment plus adjunctive therapy (oxygen-releasing oral gel \u002F blue®m Oral Gel).",[45],"Drug: Topical oxygen-releasing oral gel",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":22},"DRUG","Topical oxygen-releasing oral gel","Scaling and root debridement (RSD), a standard non-surgical periodontal procedure involving mechanical removal of subgingival plaque and calculus using ultrasonic and\u002For hand instrumentation. RSD will be performed at baseline on all sites (both test and control), and repeated at 6 weeks, 3 months, and 6 months if clinically indicated based on residual probing pocket depth or bleeding on probing. BlueM® oral gel is a topical oxygen-releasing oral gel, containing sodium perborate and lactoferrin as active ingredients. The gel will be applied subgingivally to the test site immediately following scaling and root debridement at baseline, and reapplied once more at the 1-week follow-up visit. No further gel application will occur after week 1.",[41],{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":22},"No intervention","Scaling and root debridement (RSD), a standard non-surgical periodontal procedure involving mechanical removal of subgingival plaque and calculus using ultrasonic and\u002For hand instrumentation. RSD will be performed at baseline on all sites (both test and control), and repeated at 6 weeks, 3 months, and 6 months if clinically indicated based on residual probing pocket depth or bleeding on probing. The control arm receive the standard treatment and will not be receiving any placebo gel.",[35],[57],{"name":58,"role":59,"phone":60,"phoneExt":22,"email":61},"Anis Izzati Abdul Aziz","CONTACT","+6017-2512534","anisizzati2804@gmail.com",[63],{"facility":64,"status":22,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"School of Dental Sciences, Health Campus, Universiti Sains Malaysia","Kota Bharu","Kelantan","16150","Malaysia","MY",{"type":71,"coordinates":72},"Point",[73,74],102.24333,6.12361,{"lat":74,"lon":73},[77],{"name":58,"role":59,"phone":78,"phoneExt":22,"email":61},"+017-2512534",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Anis Izzati binti Abdul Aziz","Principal Investigator","100657568","clinical-effectiveness-of-oxygen-releasing-oral-gel-as-an-adjunct-to-scaling-and-root-debridement-in-patients-with-severe-periodontal-pockets-a-randomized-clinical-trial-100657568",false,"NCT07840859","Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Systemically healthy individuals or individuals with a well-controlled systemic condition\n* Individuals 18 years of age or older\n* No restrictions on gender\n* Individuals diagnosed with periodontitis and present with a localised or generalised distribution of deep pockets\n* There is presence of more than one qualifying severe periodontal pocket measuring ≥ 6 mm\n* There must be at least two qualifying severe pocket profiles present (one for the experimental site and one for the active control site)\n\nExclusion Criteria:\n\n* Individuals who have received any form of non-surgical or surgical periodontal therapy within the past 6 months\n* Smokers or tobacco chewers\n* Pregnant or lactating mothers\n* Individuals who have received systemic antibiotic therapy within the past 3 months\n* Individuals who require prophylactic antibiotic coverage prior to dental procedures\n* Individuals who are currently using topical antiseptics\n* Currently on antiplatelet or anticoagulant therapy\n* Individual with bleeding disorder","ALL","18 Years",{"count":92,"type":93},38,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this clinical trial is to learn if adding an oxygen-releasing gel to a deep dental cleaning treatment can improve gum health more than deep cleaning alone, in adults with severe gum disease. The main questions it aims to answer are:\n\n1. Does adding oxygen-releasing gel to deep cleaning reduce the depth of gum pockets more than deep cleaning alone?\n2. Does adding oxygen-releasing gel to deep cleaning lead to greater improvement in gum attachment, less gum recession, less plaque, and less bleeding, compared to deep cleaning alone?\n3. Do any improvements last for up to 6 months?\n\nResearchers will compare one side of each participant's mouth, treated with deep cleaning plus oxygen-releasing gel, to the other side, treated with deep cleaning alone, to see if adding the gel produces a bigger and longer-lasting improvement in gum health.\n\nParticipants will:\n\n* Attend 5 visits over 6 months\n* Receive deep cleaning (scaling and root debridement) on both sides of the mouth at visits where it is needed\n* Have one side of the mouth randomly chosen, using a method similar to drawing lots, to also receive the oxygen-releasing gel\n* Receive the gel twice: once at the first visit, and again one week later\n* Have their gum measurements checked at each visit",[99],"Periodontitis",[99,101,102,103,104,105],"Severe periodontal pockets","Scaling and root debridement (SRD)","Non-surgical periodontal therapy","Oxygen-releasing oral gel","Adjunctive periodontal therapy","NOT_YET_RECRUITING","2026-09-26",{"date":109,"type":110},"2026-09-30","ACTUAL",{"date":112,"type":93},"2026-11",{"date":114,"type":93},"2028-03",{"name":5,"class":6},1]