A Comparative Study of the Efficacy in Plaque Removal of Two Manual Toothbrushes
Condition: Tooth Caries; Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      Objective: To compare the efficacy of Curaprox® CS 5460 Ultra Soft and Oral-B® Indicator Plus
      toothbrushes in dental plaque removal. Methods: 50 adult participants will be included in the
      sample. For a period of 24 hours (at two different times), they will be instructed to stop
      oral hygiene. During the final 4 hours, the interruption of consumption of foods and liquids
      will be recommended, and in smokers' case, the use of cigarettes. In two clinical visits (T0
      and T1), volunteers will be asked to brush their teeth for 1 minute with Curaprox® (CS 5460
      Ultra Soft) e Oral-B® (Indicator Plus) toothbrushes. Disclosure will be performed prior to
      and after brushing and the presence of plaque on the tooth surfaces will be evaluated.
      Turesky Modified Quigley Hein Plaque Index will be used for the plaque record. For
      statistical analysis, paired t tests will be performed to compare the effectiveness of
      toothbrushes and correlation test to assess whether the fact that the patient was aware of
      the toothbrush that will be used influenced in their performance.
    

Detailed description: 
      For the study, 50 patients, between 18 and 55 years of age, of both sexes and healthy will be
      selected. For the study performance, volunteers will be instructed to stop their brushing for
      23 to 25 hours before the first clinical visit. In addition, they will be also instructed to
      stop eating (solid foods and liquids) and to stop the use of cigarettes, if smoker, for 4
      hours before evaluation. Prior to the study, a pilot study will be conducted at the
      University Hospital of Brasília for the researcher calibration using the Turesky Modified
      Quigley Hein Plaque Index, following the predetermined protocol.

      A double-blind crossover study will be designed in which each volunteer will test two
      different models of toothbrushes. Prior to the beginning of the study, the brushes handle
      will be hidden with tape in a way that it will be not possible to see the toothbrush
      trademark. During the two visits, both brushes will be placed on the workbench and in the
      absence of the researcher, the participant will select one of the brushes. In the following
      visit, the same procedure will be performed and the participant will use the second brush. A
      period of washout of at least one week between the the first visit and the second visit will
      be done to obtain non-interference between results. No brush restriction will be imposed for
      the participant during this period.
    

Intervention name(s): Curaprox 5460 Ultra Soft; Oral-B Indicator Plus
Intervention type(s): Device; Device
Intervention description(s): The toothbrush Curaprox 5460 Ultra Soft will be the tested toothbrush model, in order to asses its efficacy in plaque removal. Therefore, the study participants should brush their teeth using this toothbrush model, following the instructions of the investigator. From the data collect related in plaque removal the results will be arrived at.; Following the same method of the Curaprox group intervention, the participants should brush their teeth using the Oral-B Indicator Plus toothbrush and based on the data collect, the results will be compared with the first group of intervention.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a study designed where all the participants will have to try the two devices that were being tested.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention