AIM: To investigate the effect of the fluoride sustained slow-releasing device (FSSRD) on F levels in unstimulated saliva and undisturbed plaque biofilms over 7 days. The investigation also aimed at studying the effect of patient age on fluoride (F) concentrations in dental plaque biofilms and unstimulated saliva while using the FSSRD. STUDY DESIGN: This was a randomised control double blind cross-over study. METHODS:Sixty-five participants between the ages of 6-35 years took part in this study. The mean age of all the participants was 19.22 years with 24 participants aged between 6-16 years (mean age=11.8 years) and 41 participants aged between 16-35 years (mean age=23.57 years). Plaque biofilms were collected using a modification of the plaque generating device (MPGD) [Robinson et al., 1997]. During the whole study period, including a 7 day washout period before the first leg, all participants were asked to use only non-fluoridated toothpaste and to avoid where possible high fluoride containing foods or drinks. Whenever possible, the FSSRD/placebo device (PD) was attached to the second permanent molar, while the MPGD was attached to the first permanent molars in the same upper dental quadrant. At the end of each leg of the study whole, mixed unstimulated saliva was collected from all participants and analysed for F concentration. STATISTICS: Statistical analysis using paired sample t-test was used to compare the results of F level between test and control groups, while, Spearman's correlation coefficient was used to test the relationship between patient's age and plaque weight against F concentration in plaque and saliva. RESULTS: There was no statistically significant difference in F concentration in plaque and saliva between the test and control groups when analysed using paired sample t-test (p>0.05). There was no correlation between patient's age and F concentration in dental plaque and saliva (p>0.05), in both the test and control groups. CONCLUSIONS: Our data showed no effect of the FSSRD in raising F concentrations in dental plaque and unstimulated whole saliva after 7 days. Such levels may require longer periods to become established.
RCT Entities:
AIM: To investigate the effect of the fluoride sustained slow-releasing device (FSSRD) on F levels in unstimulated saliva and undisturbed plaque biofilms over 7 days. The investigation also aimed at studying the effect of patient age on fluoride (F) concentrations in dental plaque biofilms and unstimulated saliva while using the FSSRD. STUDY DESIGN: This was a randomised control double blind cross-over study. METHODS: Sixty-five participants between the ages of 6-35 years took part in this study. The mean age of all the participants was 19.22 years with 24 participants aged between 6-16 years (mean age=11.8 years) and 41 participants aged between 16-35 years (mean age=23.57 years). Plaque biofilms were collected using a modification of the plaque generating device (MPGD) [Robinson et al., 1997]. During the whole study period, including a 7 day washout period before the first leg, all participants were asked to use only non-fluoridated toothpaste and to avoid where possible high fluoride containing foods or drinks. Whenever possible, the FSSRD/placebo device (PD) was attached to the second permanent molar, while the MPGD was attached to the first permanent molars in the same upper dental quadrant. At the end of each leg of the study whole, mixed unstimulated saliva was collected from all participants and analysed for F concentration. STATISTICS: Statistical analysis using paired sample t-test was used to compare the results of F level between test and control groups, while, Spearman's correlation coefficient was used to test the relationship between patient's age and plaque weight against F concentration in plaque and saliva. RESULTS: There was no statistically significant difference in F concentration in plaque and saliva between the test and control groups when analysed using paired sample t-test (p>0.05). There was no correlation between patient's age and F concentration in dental plaque and saliva (p>0.05), in both the test and control groups. CONCLUSIONS: Our data showed no effect of the FSSRD in raising F concentrations in dental plaque and unstimulated whole saliva after 7 days. Such levels may require longer periods to become established.
Authors: C Robinson; J Kirkham; R Percival; R C Shore; W A Bonass; S J Brookes; L Kusa; H Nakagaki; K Kato; B Nattress Journal: Caries Res Date: 1997 Impact factor: 4.056