# New Instrument for Oral Hygiene of Children with Clert Lip and Palate
## 3 The Efficacy of the Cleft Toothbrush  
A prototype of the Cleft Toothbrush was fabricated by the company CURAPROX, using a 3D fused deposition modelling (FDM) technique. The body was built in ABS, while the bristles were made of nylon.  
The efficacy of the Cleft Toothbrush was evaluated in a preliminary study performed in a child with a cleft lip and palate, Spina classification type I [17], four year old, male, after informed consent by his parents. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of the Faculty of Dentistry, University of Porto, Portugal.  
The performance of the Cleft Toothbrush in the bacterial plaque removal was compared with that of a manual conventional toothbrush (small head brush, bristles of medium hardness, all of the same size, which were present only in one side of the brush), using the same protocol.  
Due to the child's age, his parents were responsible for his oral hygiene, in accordance with the American Academy of Pediatric Dentistry [18]. The study was performed at the participant's home using the protocol below.  
First, the clef area to be evaluated was clearly defined. This included the vestibular faces of the adjacent teeth, on the left (supernumerary canine) and right side (central incisor) (Figure 3a).  
After, evaluation of the bacterial plaque was performed by using an Adapted Plaque Index to the Cleft (adapted PI-C) suitably adapted to be conducted at the child's home. First, in order to evidence the bacterial plaque, 2% erythrosine was used, as in the Greene and Vermillion index [19]. Then, the Adapted Plaque Index was calculated by dividing the sum of the amount of dental surface stained of each tooth by the number of observed teeth to obtain an average value. The adapted PI-C can have a score ranging from 0 to 3, which corresponds to the amount of dental surface stained with erythrosine 2% (0: no staining; 1: staining \(<\) 1/3; 2: staining between 1/3 and 2/3; 3: staining \(>\) 2/3.  
An adapted PI-C of 3 was selected as the baseline value for evaluating the efficacy of the Cleft Toothbrush in bacterial plaque removal, as well as for the conventional toothbrush, for comparative purposes.  
The brushing procedure was conducted with either the Cleft Toothbrush or the conventional toothbrush using a well-defined protocol: brushing after breakfast and dinner, with a brushing duration of 2 min [20]. The brushing with the Cleft Toothbrush or the conventional toothbrush was performed in  
Figure 3: Intraoral photographs from a child with cleft lip and palate, Spina type I, (a complete cleft lip on the left side); (**a**) the teeth were stained to evidence the bacterial plaque, 1—food in the deep cleft, 2—The supernumerary is the tooth with more bacterial plaque on the surface; (**b**) brushing with the Cleft Toothbrush—the front bristles were used to enter the cavity of the cleft, combining rotation and translation movements; and (**c**) the mouth after brushing, showing the high efficacy in bacterial plaque removal.  
two different moments, i.e., separated by two weeks. Figure 3b illustrates the cleft cleaning procedure using the designed Cleft Toothbrush.  
Immediately after the last brushing procedure (after dinner), the plaque index was again evaluated, using the Adapted PI-C, in order to analyze the efficacy of the bacterial plaque removal. Using the Cleft Toothbrush, the Adapted PI-C decreased from 3 to 1, whereas with the conventional brush a reduction from 3 to 2 was achieved.  
Additionally, the Cleft Toothbrush had a very good acceptance by the child and his parents. It was stated that the new cleft toothbrush was more effective in brushing and cleaning deeper areas of the cleft, compared to the conventional toothbrush. They also felt that the new brush was safer to use in the sensitive tissues of the cleft area.