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临床试验/DRKS00028633
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Improvement in oral hygiene with toothpaste containing a plaque indicator - a controlled clinical study - MHPi

niversität Witten/HerdeckeFakultät für GesundheitDepartment für Zahn-, Mund- und KieferheilkundeAbt. für Zahnerhaltung und Präventive Zahnmedizin0 个研究点目标入组 80 人开始时间: 2022年3月30日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
80

研究概览

简要总结

Objectives To evaluate the efficacy of a plaque revealing toothpaste in reducing plaque and improving oral hygiene compared to a conventional toothpaste. Methods A total of 80 subjects participated in the investigator-blind study using a parallel group design examiner-blind study. Participants were stratified according to gender and age and randomly assigned to two groups: (1) toothbrushing with a plaque revealing toothpaste (Mara expert ® Plaque Checker); (2) toothbrushing with a conventional toothpaste (Odol-med3 Original). A screening, baseline, interim and final examination took place over an eight-week period. Screening and baseline examinations were combined whenever possible. During each examination the Quigley-Hein-Index modified by Turesky (mQHI), the Proximal-Plaque-Index modified by Zimmer et al. (mPPI) as well as the Papillary Bleeding Index by Saxer und Mühlemann (PBI) were recorded. In addition, toothpaste consumption was determined at the interim and final examination to evaluate compliance. At baseline examination a questionnaire was handed out. For statistical analysis the differences between baseline and interim (U1_U2) as well as baseline and final (U1_U3) examination were compared between the two groups. The Independant-Samples-Median-Test was used. For evaluation of the questionnaire the Pearson-Chi-Square-Test was used. Results After four drop-outs and no protocol violation 76 participants (1: n=38, 2: n=38) were included into final analysis. Both groups improved their oral hygiene over the course of the study. The improvements of t group 1 differed significantly on all three indices compared to group 2. U1-U2 ?1mQHI (1) 0,58, (2) 0,22; U1-U3 ?2mQHI (1) 0,73, (2) 0,17; U1-U2 ?1mPPI (1) 0,43, (2) 0,18; U1-U3 ?2mPPI (1) 0,54, (2) -0,02; U1-U2 ?1PBI 0,44, (2) 0,15; U1-U3 ?2PBI (1) 0,49, (2) 0,25. Only 47% of users would continue to integrate the Mara expert ® toothpaste into their daily brushing routine. The taste of this toothpaste was not rated as good. Conclusions The significantly positive improvement in oral hygiene of group 1 compared to group 1 shows that oral hygiene can be improved with the help of a toothpaste that stains biofilm in use. Despite the positive results, the test toothpaste was not rated well by the subjects.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 65 Years(—)
性别
All

入选标准

  • At least 16 uncrowned teeth
  • Papillary bleeding index = 0.5
  • Quigley-Hein Plaque Index (modified from Turesky) =2
  • Existing declaration of consent for study participation

排除标准

  • Pregnancy and lactation or planning a pregnancy during the study period
  • Uncontrolled diabetes (types I and II)
  • Existing removable dentures
  • Fixed or removable orthodontic appliances
  • Aggressive or severe chronic periodontitis
  • Previous participation in the study
  • Participation in another clinical study or use of another investigational product within the last 30 days prior to the first study
  • Use of antibiotics within the last 14 days before the first examination or other medication or therapy that could influence the study results.
  • Known or suspected allergy to one or more toothpaste ingredients
  • Alcohol or drug abuse within one year prior to the start of the first investigation

研究者

发起方
niversität Witten/HerdeckeFakultät für GesundheitDepartment für Zahn-, Mund- und KieferheilkundeAbt. für Zahnerhaltung und Präventive Zahnmedizin

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