[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dental-calculus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dental-calculus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100646439","bio-descaling-toothpaste-for-dental-calculus-reduction-100646439",false,"NCT07689071","Bio-Descaling Toothpaste for Dental Calculus Reduction","Efficacy of a Novel Toothpaste Containing a Bio-Descaling Powder (BDP) in Reducing Dental Calculus: A Double Blind Randomized Controlled Clinical Trial","AntiCal","Inclusion Criteria:\n\nPatients with a healthy but reduced periodontium undergoing a supportive periodontal care (SPC) program and\u002For patients with biofilm induced gingivitis, fulfilling the following criteria:\n\n1. Aged 18 years and older;\n2. Systemically healthy, following the criteria of American Society of Anesthesiology (ASA), type I or II;\n3. Having at least 10 opposing teeth units with presence of at least three natural lower anterior teeth;\n4. Presenting at least 1.5 mm of calculus width on the lingual surface of at least one mandibular anterior teeth (Volpe-Manhold index of at least 1.5 in the lingual side of at least one of the lower anterior teeth) ;\n5. For patients in SPC, for at least 6 months, and the last tooth cleaning at least 3 months before, fulfilling the end point criteria of periodontal therapy \\[no pockets ≥ 6 mm or \\> 4 mm with bleeding on probing (BOP)\\] . Localized pockets of 6 mm, without bleeding on probing, are allowed, except in the anterior-inferior sextant.\n6. Agree to follow the study instructions, including adherence to study arm treatment, for the study timeline.\n\nExclusion Criteria:\n\nSubjects will be excluded from participating in the study if:\n\n1. Pregnancy: pregnant women at high risk of developing gum inflammation that usually occurs during pregnancy, which could introduce bias to the study;\n2. Any physical handicap, psychological or health conditions that might jeopardize the ability of the patient to brush his\u002F her teeth, these complications may cause bias in the study. Smokers of 10 or more cigarettes per day will be excluded (Dietrich, Bernimoulin, \\& Glynn, 2004);\n3. Antibiotics or anti-inflammatory drugs taken within 1 month prior to the study, to avoid bias when assessing the gum health;\n4. Currently using chlorhexidine or other antiseptic products, since these products can affect biofilm and calculus formation, therefore they can introduce bias in the assessment of calculus removal by our toothpaste;\n5. Sensitivity to tartar-control toothpastes;\n6. Unable to return for evaluations\u002Fstudy recalls, to avoid the significant loss in the number of participants.",true,"ALL","18 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","Dental calculus is a calcified mineralized plaque composed primarily of calcium phosphate salts covered by an unmineralized bacterial biofilm layer. It provides a substrate for bacterial colonization and soft biofilm retention, promoting the growth of pathogenic plaque, further calculus formation, gingival tissue inflammation, that could progress to periodontitis and tooth loss. Therefore, removal of dental calculus and prevention of its formation are important for maintaining periodontal health.\n\nProfessional mechanical removal remains the most effective approach to control existing dental calculus; however, it is labor-intensive and represents a burden for patients in terms of costs and access to oral health professionals. Several toothpastes have been developed to dissolve and soften mineralized deposits using abrasive and\u002For chemical agents. Nevertheless, highly abrasive formulations may damage tooth structures and only reduce approximately 30-50% of dental calculus, while dentifrices containing mineralization and crystallization inhibitors can prevent calculus formation but are unable to remove already formed deposits.\n\nTo address these limitations, a Bio-Descaling Powder (BDP) toothpaste has recently been introduced with the aim of removing existing dental calculus. Preliminary clinical evidence showed that the amount of calculus removed with D-Tart toothpaste was five times greater than that achieved with Colgate Total® toothpaste.\n\nGiven the high prevalence of periodontal diseases and the potential role of dental calculus in their initiation and progression, effective strategies for calculus removal and prevention are of considerable clinical interest. The use of an effective toothpaste could reduce the need for professional periodontal interventions or shorten treatment time, thereby decreasing costs and patient burden.\n\nThe aim of this study is to evaluate the efficacy of a Bio-Descaling Powder (BDP)-containing toothpaste, compared with a placebo toothpaste, in decreasing the presence of already formed dental calculus.",[28,29,30],"Dental Calculus","Gingivitis and Periodontal Diseases","Periodontal Diseases",[32,33,34,35,36,37,38],"dental calculus","calculus removal","Bio-descaling powder toothpaste","Periodontal Maintenance","Gingival inflammation","Supportive Periodontal Care","Periodontal diseases","NOT_YET_RECRUITING","2026-07-04",{"date":42,"type":43},"2026-07-08","ACTUAL",{"date":45,"type":22},"2026-07",{"date":47,"type":22},"2027-01",{"name":49,"class":50},"Universidad Complutense de Madrid","OTHER"]