OBJECTIVE: The purpose of this study was to test the efficacy and safety of a newly designed multi-level manual toothbrush (Profit-Haije-Brush) compared with a control flat-trimmed manual reference toothbrush from the American Dental Association (ADA). MATERIAL AND METHODS: For this study, 36 healthy subjects without previous experience in the use of the Profit-Haije-Brush (PHB) were selected. Subjects were given a period of 2 weeks to become familiar with both types of brushes and were instructed to use them on alternate days for 2 min twice daily. Prior to their visit, subjects refrained from all oral hygiene procedures for 48 h. Prebrushing plaque and gingival abrasion scores were assessed. Subsequently, two randomly chosen contra-lateral quadrants were brushed with one of both brushes and the other two quadrants with the alternate brush. Subjects were supervised during their 2-min brushing exercise. After brushing, plaque and gingival abrasion were re-assessed. A questionnaire was filled out to investigate the subjects' attitudes towards both brushes. RESULTS: The overall mean prebrushing PI was 2.47 for the PHB and 2.44 for the ADA. The reduction in PI was 1.32 and 1.23 respectively (P < 0.05). With regard to gingival abrasion the overall mean prebrushing scores were 4.57 (PHB) and 5.34 (ADA). Post-brushing scores were 13.49 and 13.77 for the PHB and ADA respectively. CONCLUSION: Statistically, the multi-level PHB was significantly more efficacious than the flat-trimmed ADA. However, the difference is clinically considered small and the amount of remaining plaque was not significantly different between brushes. No greater potential to cause gingival abrasion to the oral tissues was observed.
RCT Entities:
OBJECTIVE: The purpose of this study was to test the efficacy and safety of a newly designed multi-level manual toothbrush (Profit-Haije-Brush) compared with a control flat-trimmed manual reference toothbrush from the American Dental Association (ADA). MATERIAL AND METHODS: For this study, 36 healthy subjects without previous experience in the use of the Profit-Haije-Brush (PHB) were selected. Subjects were given a period of 2 weeks to become familiar with both types of brushes and were instructed to use them on alternate days for 2 min twice daily. Prior to their visit, subjects refrained from all oral hygiene procedures for 48 h. Prebrushing plaque and gingival abrasion scores were assessed. Subsequently, two randomly chosen contra-lateral quadrants were brushed with one of both brushes and the other two quadrants with the alternate brush. Subjects were supervised during their 2-min brushing exercise. After brushing, plaque and gingival abrasion were re-assessed. A questionnaire was filled out to investigate the subjects' attitudes towards both brushes. RESULTS: The overall mean prebrushing PI was 2.47 for the PHB and 2.44 for the ADA. The reduction in PI was 1.32 and 1.23 respectively (P < 0.05). With regard to gingival abrasion the overall mean prebrushing scores were 4.57 (PHB) and 5.34 (ADA). Post-brushing scores were 13.49 and 13.77 for the PHB and ADA respectively. CONCLUSION: Statistically, the multi-level PHB was significantly more efficacious than the flat-trimmed ADA. However, the difference is clinically considered small and the amount of remaining plaque was not significantly different between brushes. No greater potential to cause gingival abrasion to the oral tissues was observed.