Salus Research, Inc., 1220-4 Medical Park Dr., Fort Wayne, IN, 46825, USA.
Pontis Biologics, Inc., Long Island High Technology Incubator, 25 Health Sciences Dr., Stony Brook, NY, 11790, USA.
BMC Oral Health. 2024 Jun 22;24(1):720. doi: 10.1186/s12903-024-04498-x.
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.
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).
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.
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.
This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.
安全、在家中溶解牙石是 OTC 医疗保健行业面临的更具挑战性的问题之一。Pontis Biologics, Inc. 开发了一种新的牙石发育和结构模型，并开发了一种使用消化酶作为活性成分的牙粉（Tartarase™），在这项原理验证临床试验中显示可溶解牙石。
本研究旨在评估一种新型酶配方的安全性和有效性，该配方可在 4 周内使用 Volpe-Manhold 指数 (V-MI) 去除舌侧 6 颗下前牙的现有牙石沉积物。测试配方与 Crest Cavity Protection 进行比较，作为对照牙粉。共有 40 名随机受试者开始研究，其中 20 名受试者分配到对照组，20 名受试者分配到 Tartarase 组（各 10 名，一组每天用 Tartarase 刷牙两次，一组每天用 Tartarase 刷牙并佩戴装满 Tartarase 的牙托 30 分钟，然后再用 Tartarase 刷牙一次）。
Crest 组的牙石增加了 12%，而 Tartarase 两组的牙石减少了 40%，在 4 周的非监督家庭使用 Tartarase 牙粉配方后。
这项原理验证研究表明，一种牙粉配方，按照 Tartarase 材料的配方，可以通过使用全球普遍存在的相同口腔卫生习惯来对抗牙石的积累。
本试验在 clinicaltrials.gov 进行了回顾性注册，注册号为：NCT06139835，2023 年 11 月 14 日。
