[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650965":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":56,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arginine Toothpaste Use for Two Times Per Day for 6 Months","EXPERIMENTAL",null,[13],"Device: Arginine Toothpaste",{"label":15,"type":16,"description":11,"interventionNames":17},"Fluoride Toothpaste Use for Two Times Per Day for 6 Months","ACTIVE_COMPARATOR",[18],"Device: Fluoride Toothpaste",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Arginine Toothpaste","Participants will use arginine toothpaste twice daily (morning and evening) for 6 months. Sterile paper will be used to collect plaque from below the gum line at baseline, 3 months, and 6 months.",[9],[26],"Tom's of Maine",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Fluoride Toothpaste","Participants will use fluoride toothpaste twice daily (morning and evening) for 6 months. Sterile paper will be used to collect plaque from below the gum line at baseline, 3 months, and 6 months.",[15],[32],"Colgate Cavity Protection",[34],{"name":35,"affiliation":5,"role":36},"Sukirth Ganesan, BDS,PhD,MPH","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":11,"email":41},"CONTACT","(319) 467-1475","sukirth-ganesan@uiowa.edu",[43],{"facility":44,"status":11,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":11},"The University of Iowa College of Dentistry","Iowa City","Iowa","52242","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-91.53017,41.66113,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Sukirth M Ganesan, BDS, PhD","Principal Investigator","100650965","impact-of-an-arginine-containing-toothpaste-on-the-subgingival-microbiota-in-patients-in-supportive-periodontal-care-100650965",false,"NCT07755800","Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care","Inclusion Criteria:\n\n* Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee.\n* Female or male, ages 18-95 years old (inclusive)\n* Systemically healthy.\n* Presence of at least three evaluable teeth in each quadrant.\n* Moderate gingival inflammation, with at least a 10% of bleeding on probing (BOP) will be required together with moderate level of plaque.\n* No Grade 3 Tooth Mobility\n* Treated stage II or III periodontitis patients, whose active treatment has finalized more than 6 months before. Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss equal to 3 to 4 millimeters with maximum probing depth of less than or equal to 5 millimeters. Stage III - Interdental CAL at the site of greatest loss greater than equal to 5 millimeters, probing depth (PD) greater than or equal to 6 millimeters, and radiographic vertical bone loss\n* Enrolled in a periodontal maintenance treatment program\n* No orthodontic banding (no permanent retainers, no orthodontic appliances (i.e., no removable plastic\u002Fmetal retainer) or removable prosthesis (no removable partial and\u002For full denture).\n* Subjects willing to participate and comply with the requirements of the study.\n* Subjects that brush their teeth regularly (once or twice daily).\n* Able to travel to and attend 4 research study visits over the span of the next 6 months.\n* Able to independently provide consent for oneself.\n* Fluent in reading, comprehending, and speaking English without assistance from a translator.\n* If a patient is using prevident, they must be willing to stop using it.\n\nExclusion Criteria:\n\n* Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and\u002For extensive alveolar bone loss)\n* Antibiotics intake within the previous month.\n* Pregnant women and\u002For breastfeeding women\n* Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.\n* Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).\n* Not willing to comply with the study protocol recommendation and visit schedule.\n* Current smokers or those using tobacco or vaping products.\n* Five (5) or more decayed, untreated dental sites (cavities) and\u002For any dental condition requiring urgent dental care\n* Currently participating in another clinical research study now and\u002For within the past month.\n* Has a history of allergies to oral care or personal care consumer products or their ingredients\n* Has an existing medical condition that prohibits eating or drinking for periods up to 4 hours.\n* Any ongoing medical condition that makes a subject unsuitable for enrollment-or any new diagnosis that arises during the study that makes the subject unsuitable to continue-may lead to exclusion, as determined by the Principal Investigator on a case by case basis. Conditions that may result in exclusion include, but are not limited to:\n\n  1. Recent myocardial infarction\n  2. Recent cerebrovascular accident\n  3. Recent placement of a cardiac valvular prosthesis\n  4. Severe liver dysfunction\n  5. Known or suspected current malignancy\n  6. New antibiotic use\n  7. Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and\u002For continued participation.","ALL","18 Years","95 Years",{"count":70,"type":71},108,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study aims to see how a toothpaste with arginine affects bacteria below the gum line compared to a regular fluoride toothpaste. It focuses on people with gum disease who are already getting ongoing dental care.\n\nThe main questions it aims to answer are:\n\n* How does an arginine toothpaste affect the bacteria below the gumline?\n* How does a fluoride toothpaste affect the bacteria below the gumline?\n\nParticipants will:\n\n* Use fluoride toothpaste or arginine toothpaste twice daily for 6 months\n* After receiving the toothpaste at the baseline visit, subjects will visit the clinic at 3 months and 6 months for additional data collection.",[77],"Gum Disease","NOT_YET_RECRUITING","2026-08-04",{"date":81,"type":82},"2026-08-10","ACTUAL",{"date":84,"type":71},"2026-08",{"date":86,"type":71},"2028-07",{"name":58,"class":6},1]