PDF(Pubmed)
Abstract：
BACKGROUND: The dissolution of dental calculus, safely and at home, is among the more challenging issues facing the over-the-counter healthcare industry. Pontis Biologics, Inc. has developed novel model of calculus development and structure and has formulated a dentifrice (Tartarase™) using digestive enzymes as active ingredients that is shown to dissolve dental calculus in this Proof of Principle clinical trial.
METHODS: This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4 weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30 min then brushed again with Tartarase, once daily).
RESULTS: The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4 weeks of unsupervised at home use of the Tartarase toothpaste formulation.
CONCLUSIONS: This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide.
BACKGROUND: This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.
METHODS: This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4 weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30 min then brushed again with Tartarase, once daily).
RESULTS: The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4 weeks of unsupervised at home use of the Tartarase toothpaste formulation.
CONCLUSIONS: This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide.
BACKGROUND: This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.
摘要：
背景：牙结石的溶解，安全在家，是非处方药医疗保健行业面临的更具挑战性的问题之一。庞蒂斯生物制品，Inc.开发了牙结石开发和结构的新型模型，并使用消化酶作为活性成分配制了一种洁齿剂（Tartarase™），在此原理证明临床试验中显示出可溶解牙结石。
方法：这项研究旨在评估一种新型酶制剂在4周内清除现有牙结石沉积物的安全性和有效性，在6颗下前牙的舌面使用Volpe-Manhold指数（V-MI）进行测量。将测试配方与波峰腔保护进行比较，作为控制牙膏。共有40名随机测试受试者开始了这项研究，其中20人被分配到对照洁齿剂中，20人被分配到酒石酸酶组(每人10人，每天两次用酒石酸酶刷牙，一次用酒石酸酶刷牙，并佩戴充满酒石酸酶的牙科托盘30分钟，然后再次用酒石酸酶刷牙，每天一次)。
结果：佳洁士组的结石增加了12%，与两个Tartarase组的结果相反，在家中无监督使用Tartarase牙膏配方的4周内，结石减少了40％。
结论：这项原理证明研究表明，牙膏，按照酒石酸酶材料的路线配制，能够使用全球常见的口腔卫生习惯来对抗结石积聚。
背景：该试验在clinicaltrials.gov进行了回顾性注册，其唯一标识号为：NCT06139835，14/11/2023。
方法：这项研究旨在评估一种新型酶制剂在4周内清除现有牙结石沉积物的安全性和有效性，在6颗下前牙的舌面使用Volpe-Manhold指数（V-MI）进行测量。将测试配方与波峰腔保护进行比较，作为控制牙膏。共有40名随机测试受试者开始了这项研究，其中20人被分配到对照洁齿剂中，20人被分配到酒石酸酶组(每人10人，每天两次用酒石酸酶刷牙，一次用酒石酸酶刷牙，并佩戴充满酒石酸酶的牙科托盘30分钟，然后再次用酒石酸酶刷牙，每天一次)。
结果：佳洁士组的结石增加了12%，与两个Tartarase组的结果相反，在家中无监督使用Tartarase牙膏配方的4周内，结石减少了40％。
结论：这项原理证明研究表明，牙膏，按照酒石酸酶材料的路线配制，能够使用全球常见的口腔卫生习惯来对抗结石积聚。
背景：该试验在clinicaltrials.gov进行了回顾性注册，其唯一标识号为：NCT06139835，14/11/2023。
