OBJECTIVE: The purpose of this single-blind clinical study was to evaluate the efficacy of an innovative manual toothbrush versus a traditional one. METHODS: The toothbrushes were randomly assigned to 30 volunteers in a student population of the Dental School of the University of Bologna, Italy, divided into 15 test and 15 control subjects. A clinical examination assessing Plaque Index (PI), Gingival Index (GI) and buccal Gingival Recessions was performed at baseline, 3 and 6 months. During the baseline examination, each subject received dental debridement, oral hygiene instructions and a standard kit containing: three standard tubes of toothpaste, 1 hourglass (2 min) and one plaque disclosing solution; each subject of the test group received three innovative toothbrushes, while each subject of the control group received three traditional toothbrushes. RESULTS: During the 6 months of observation both groups presented a PI and GI decrease. A more evident improvement of both indices was observed in the test group (PI P = 0.0001, GI P = 0.0001). The greatest part of recessions remained stable (0-3 months: 70% test group, 60% control group and 3-6 months: 86% test group, 94% control group). Some amplitude modifications (0.5 mm) were mainly detected in the first 3 months (control group chi(2) = 17.55, P = 0.0001 and test group chi(2) = 3.31, P = 0.07). They always increased in the control group and decreased in the study group. CONCLUSIONS: The innovative manual toothbrush is more likely to be effective in reducing PI and GI compared to the traditional one and widely safe on periodontal tissues during the period of observation.
RCT Entities:
OBJECTIVE: The purpose of this single-blind clinical study was to evaluate the efficacy of an innovative manual toothbrush versus a traditional one. METHODS: The toothbrushes were randomly assigned to 30 volunteers in a student population of the Dental School of the University of Bologna, Italy, divided into 15 test and 15 control subjects. A clinical examination assessing Plaque Index (PI), Gingival Index (GI) and buccal Gingival Recessions was performed at baseline, 3 and 6 months. During the baseline examination, each subject received dental debridement, oral hygiene instructions and a standard kit containing: three standard tubes of toothpaste, 1 hourglass (2 min) and one plaque disclosing solution; each subject of the test group received three innovative toothbrushes, while each subject of the control group received three traditional toothbrushes. RESULTS: During the 6 months of observation both groups presented a PI and GI decrease. A more evident improvement of both indices was observed in the test group (PI P = 0.0001, GI P = 0.0001). The greatest part of recessions remained stable (0-3 months: 70% test group, 60% control group and 3-6 months: 86% test group, 94% control group). Some amplitude modifications (0.5 mm) were mainly detected in the first 3 months (control group chi(2) = 17.55, P = 0.0001 and test group chi(2) = 3.31, P = 0.07). They always increased in the control group and decreased in the study group. CONCLUSIONS: The innovative manual toothbrush is more likely to be effective in reducing PI and GI compared to the traditional one and widely safe on periodontal tissues during the period of observation.