[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plaque\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plaque":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,78,103,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100640564","phase-4-clinical-study-to-collect-and-analyze-dental-plaque-and-oral-health-measures-in-a-population-with-high-plaquelow-gingivitis-and-high-plaquehigh-gingivitis-100640564",false,"NCT07614490","Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque\u002FLow Gingivitis and High Plaque\u002FHigh Gingivitis","Inclusion Criteria:\n\n* Male or female volunteers at least 18 years of age and in general good health.\n* Willing and able to understand and sign the informed consent form.\n* Must have a whole mouth mean TPI score ≥ 3.25\n* N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI\\\u003C20%)\n* Must have at least two areas in the mouth with high plaque\u002Flow inflammation and two areas with high plaque\u002Fhigh inflammation\n* Be willing to conform to the study protocol and procedures.\n* Minimum of 20 natural teeth with scorable facial and lingual surfaces\n\nExclusion Criteria:\n\n* Medical condition which requires premedication prior to dental visits\u002Fprocedure.\n* Known history of allergy to personal care\u002Fconsumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.\n* Active disease of the hard oral tissues.\n* Significant oral soft tissue pathology, excluding plaque-induced gingivitis.\n* Subjects with fixed or removable orthodontic appliances or removable partial dentures.\n* Dental prophylaxis within 30 days prior to study start.\n* Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.\n* Use of chemotherapeutic oral care products within two weeks prior to study start.\n* Participation in any other clinical study within 30 days prior to enrollment into this study.\n* Subjects who must receive dental treatment during the study dates.\n* Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).\n* Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.\n* Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)\n* Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.\n* Medical condition which prohibits not eating\u002Fdrinking or chewing gum for four (4) hours prior to your scheduled visits;\n* Subjects who have an infectious disease and\u002For other blood borne diseases (Hepatitis series, HIV, tuberculosis).","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque\u002Flow gingivitis and high plaque\u002Fhigh gingivitis",[25,26],"Gingivitis","Plaque","RECRUITING","2026-05-22",{"date":30,"type":31},"2026-05-29","ACTUAL",{"date":33,"type":31},"2026-04-20",{"date":35,"type":19},"2026-10-15",{"name":37,"class":38},"Colgate Palmolive","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":60,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100588282","intracoronary-cryotherapy-effect-on-stabilization-of-vulnerable-plaque-in-patients-with-stable-angina-or-acs---a-traditional-feasibility-study-100588282","NCT06939374","Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study","Clinical Investigation of the Efficacy and Safety of Intracoronary Cryotherapy Using the CryoTherapy System (CTS) for High-risk Plaque in Patients With Stable Angina or Acute Coronary Syndrome.","ICECAP","Inclusion Criteria:\n\n* 1\\) Subject is at least 18 years old. 2) Subject has acute cardiac pain\u002Fangina consistent with stable angina or acute coronary syndrome eligible for coronary angiography meeting one of the following criteria:\n\n  1. Non-ST-segment elevation myocardial infarction (NSTEMI) with rise\u002Ffall of cardiac enzymes (troponin I or T) with at least one value above the 99th percentile of the upper reference limit requiring PCI within 72 hours from diagnosis\n  2. Unstable angina\n  3. ST-segment elevation myocardial infarction (STEMI) 3) Successful PCI (defined as diameter stenosis less than 30% and TIMI 3 flow on final angiography without procedural complication) of the culprit lesion.\n\nNOTE: subjects with unstable angina, for whom the culprit lesion as assessed by investigator does not require PCI currently or within the next 6 months (subject treated with optimal medical treatment) can be enrolled in the study.\n\n4\\) Subject has at least one high-risk plaque meeting the criteria below:\n\n1. Located in a non-culprit vessel,\n2. High-risk plaque lesion on CCTA and at least one of the following features:\n\n   1. Presence of low-attenuation plaque (HU\\\u003C50) and\u002For\n   2. Positive remodelling (remodelling index \\>1.1) and\u002For\n   3. Napkin ring sign and\u002For\n   4. Plaque burden ≥70%\n3. Lesion length ≤ 20 mm.\n4. Diameter stenosis on invasive angiography between 30% and 70% on coronary angiogram or negative physiology assessment (FFR\\>0.80 or NHPR\\>0.89).\n5. Reference vessel diameter (RVD) \\\u003C 3.75 mm and \\> 2.50 mm in diameter\n6. Investigator considers that lesions are accessible.\n7. If more than two suitable lesions available, investigator will select the most appropriate lesion for cryotherapy treatment.\n\n   5\\) maxLCBI4mm in the lesion \\> 324.7 6) Subject is able to provide consent and has signed and dated the informed consent form.\n\n   Exclusion Criteria:\n   * 1\\) Subject is hemodynamically unstable (cardiogenic shock, hypotension needing inotropes, hypoxia needing intubation, refractory ventricular arrhythmias, and IABP).\n\n     2\\) Subject has ongoing ST-segment elevation myocardial infarction. 3) Subject had a procedural complication during the ACS PCI procedure. 4) Subject has history of Coronary Artery Bypass Graft (CABG) or planned CABG within 12 months after the index procedure.\n\n     5\\) Subject has known reduced Left Ventricular Ejection Fraction \\\u003C 30%. 6) Subject has known severe valvular heart disease. 7) Subject has known severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin\u002F1.72 m2). 8) Subject has any life-threatening conditions or medical comorbidity resulting in life expectancy \\\u003C 12 months.\n\n     9\\) Subject is currently participating in another clinical investigation that has not yet reached its primary endpoint.\n\n     10\\) Subject has severe peripheral vascular disease impeding femoral artery access.\n\n     11\\) Subject is pregnant or lactating, or NOT surgically sterile (tubal ligation or hysterectomy) or NOT postmenopausal for at least 6 months or is a female with childbearing potential without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device).\n\n   Angiographic exclusion criteria:\n   1. Visible distal embolization\u002Fno-reflow following culprit lesions PCI.\n   2. Left main coronary artery disease (visual diameter stenosis \\> 50%).\n   3. Stent thrombosis\u002Frestenosis as a culprit lesion.\n   4. CTS lesion involving a bifurcation (defined as lesions involving side branches \\>2.0 mm).\n   5. Angiographic or CCTA evidence of severe calcification and\u002For marked tortuosity of the index vessel and\u002For lesion.\n   6. Thrombotic lesions.\n   7. Ostial lesions.",{"count":49,"type":19},30,[51],"NA","ICECAP is a multi-centre, prospective, single-arm, interventional, traditional feasibility clinical investigation to evaluate the efficacy and safety of intra-coronary cryotherapy on vulnerable or high-risk plaque (HRP), using the CryoTherapy System (CTS). The study aims to enroll 25 patients with symptomatic coronary artery disease, successfully treated for their culprit lesion and with presence of at least one HRP lesion in another vessel. Eligible patients will undergo cryotherapy during a planned procedure. Near-infrared spectrometry (NIRS and Optical Coherence Tomography imaging will be used during baseline procedure, and during a 9 months follow visit. The primary endpoint is reduction of plaque burden measured as 30% reduction in maxLCBI4mm as measured by NIRS at 9 months post procedure.",[54,26,55,56,57,58,59],"Coronary Arterial Disease (CAD)","Vulnerable Plaque","Cryotherapy","Cryotherapy Effect","Coronary Balloon","Atherosclerosis Coronary Artery With Angina Pectoris",[61,62,63,64,65,66,67],"Medical device","traditional feasibility","Single Group","Device Feasibility","Multi-Center","Prospective","Interventional","2026-03-31",{"date":70,"type":31},"2026-04-06",{"date":72,"type":31},"2025-03-01",{"date":74,"type":19},"2027-06-30",{"name":76,"class":38},"Cryotherapeutics SA",3,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":15,"minAge":16,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":20,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100631497","comparison-of-the-effects-of-oral-hygiene-regimens-on-clinical-immunomodulatory-and-microbial-outcomes-and-oral-tolerance-in-people-with-gingivitis-100631497","NCT07501455","Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis","Inclusion Criteria:\n\n2\\. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect).\n\n3\\. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit.\n\n4\\. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit.\n\n5\\. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit.\n\n6\\. Able to read and understand English. 7. Subject has signed the written informed consent (ICD) and indicated their agreement with the terms of the study and the study procedures listed and photograph release including the Health Insurance Portability and Accountability Act (HIPAA) disclosure prior to any study-related procedures.\n\n8\\. Generally, in good overall health based on the medical history reported by the subject.\n\n9\\. Has at least 18 natural teeth (not counting 3rd molars) with scorable facial and lingual surfaces.\n\n10\\. Willingness to use the assigned products according to instructions, availability for appointments, agreement to follow the subject responsibilities and likelihood of completing the clinical trial\n\nExclusion Criteria:\n\n1. Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.\n2. History of significant adverse reactions, including sensitivity or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye.\n3. Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.\n4. Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.\n5. Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.\n6. Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant (based on the examiner or PI's oral exam) cosmetic restorations.\n7. History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures.\n8. Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage.\n9. Suspected alcohol or substance abuse.\n10. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator, including a history of or a concurrent health\u002Fother condition\u002Fsituation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.\n11. Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.)\n12. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:\n\n    * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1 (81mg of aspirin is allowed).\\*\n    * Use of Immunosuppressive, or steroidal drugs therapy during the study or within 2 months before Visit 2. \\* Intermittent use (\\\u003C3 times per week) of certain anti-inflammatory medications is acceptable at the discretion of the investigator. Use of anticoagulant therapy within 1 month of screening visit or during the study.\n    * Use of systemic antibiotics within 1 month of screening visit and during the entire study.\n13. Is self-reported to be pregnant, in lactation, planning to become pregnant during the study, or positive pregnancy urine tests (females of child-bearing potential only):\n\n    * For females: Postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition prior to the first study IP administration) or premenopausal\u002Fperimenopausal state with an effective means of contraception.\n    * Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial. Medically acceptable forms of birth control that may be used by the subject and\u002For his\u002Fher partner include:\n\n      * Double barrier method (condoms, diaphragm or cervical cap with spermicide)\n      * Hormonal prescription contraceptives (i.e., oral, injectable, implanted, patch or vaginal ring hormone therapy)\n      * Intrauterine device (IUD)\n      * Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal ligation, hysterectomy and\u002For bilateral oophorectomy)\n      * Abstinence\n    * For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and for 30 days thereafter.\n14. Participation in any clinical trial within 30 days of the Screening visit.\n15. Subjects who were previously randomized into one of the study products as part of this study.\n16. Subjects who are related to the people who are involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Kenvue, contractors of Kenvue, and the families of each).\n17. Subjects within the same household as other subjects enrolled in the study at the same time.",true,"60 Years",{"count":87,"type":19},250,[51],"This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.",[91,92,26,25,93],"Microbiome","Cytokines","Gingival Bleeding","2026-03-26",{"date":96,"type":31},"2026-03-30",{"date":98,"type":31},"2026-02-26",{"date":100,"type":19},"2026-05-05",{"name":102,"class":38},"Kenvue Brands LLC",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":84,"sex":15,"minAge":16,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100628194","phase-3-a-study-to-investigate-stannous-fluoride-containing-toothpaste-on-antibacterial-effects-in-the-different-regions-of-the-mouth-100628194","NCT07458464","A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth","A Clinical Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth as Compared to Colgate Cavity Protection Toothpaste.","Inclusion Criteria:\n\n* Male and female subjects, ages 18-70, inclusive.\n* Subject is available during study duration and has no allergies to oral hygiene formulations.\n* A minimum of 20 natural teeth with facial and lingual scorable surfaces.\n* A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and clinical examination schedules.\n* Subjects with a baseline whole mouth scores of dental plaque of 1.5 or more \\[Turesky Modification of Quigley-Hein\\] and gingivitis index of 1.0 or more \\[Loe-Silness\\].\n\nExclusion Criteria:\n\n* Participation in any other clinical study or test panel including clinical studies with oral hygiene formulations within the one month prior to entry into the study.\n* History of dental prophylaxis or treatments in the past month or during study duration.\n* History of medical treatments including antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding study enrollment.\n* Subjects scheduled for medical procedures for the duration of the study.\n* Difficulty complying with study procedures and examinations such as excessive gagging during oral assessment etc.\n* History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care\u002Fconsumer products or their ingredients.\n* History of diabetes or hepatic or renal disease, or medical or inflammatory conditions or transmittable diseases, e.g. heart disease or AIDS.\n* History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.\n* Oral soft tissue pathology.\n* History of active or severe periodontal disease and loose teeth.\n* Gross dental caries, severe generalized cervical abrasion and\u002For enamel abrasion, large fractured or temporary restorations (based on visual examinations).\n* Fixed or removable orthodontic appliance or removable partial dentures.\n* Self-reported pregnancy or lactation.\n* Subjects known to be an alcoholic, or a recovering alcoholic.","70 Years",{"count":18,"type":19},[113],"PHASE3","The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva",[26,25],"NOT_YET_RECRUITING","2026-03-04",{"date":119,"type":31},"2026-03-09",{"date":121,"type":19},"2026-05",{"date":123,"type":19},"2026-06",{"name":37,"class":38},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":84,"sex":15,"minAge":16,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":20,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100441660","comoral-the-oral-irrigation-unit-clinical-trial-100441660","NCT05031260","COMORAL® the Oral Irrigation Unit Clinical Trial","Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation","COMORAL","Inclusion Criteria:\n\n* Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less\n* Those with 3 or more natural teeth in each quartile\n* Those who can voluntarily sign the consent form\n\nExclusion Criteria:\n\n* Existing dental caries\n* Existing periodontitis\n* Other oral diseases","25 Years",{"count":135,"type":19},42,[51],"This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited.\n\nTo establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday.\n\nSubjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.",[25,26],[131,140],"the oral irrigation unit","2021-08-26",{"date":143,"type":31},"2021-09-01",{"date":145,"type":19},"2021-10-01",{"date":147,"type":19},"2022-06-30",{"name":149,"class":150},"University of California, Los Angeles","OTHER"]