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Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects . Part 2 : Phase I study . Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients . Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population . However , because intensive daily self-application is required , compliance is an issue . The intraoral fluoride-releasing system ( IFRS ) containing a sodium fluoride core is a newly developed , sustained-release , passive drug delivery system that does not require patient involvement except for periodic replacement , thus reducing the effect of patient compliance on its effectiveness in dental caries prevention . Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center , with radiation-induced xerostomia , were entered into a pilot study to contrast the daily home use of a 0.4 % stannous fluoride-gel-containing tray ( control group ) to IFRS ( study group ) with respect to tolerability and adherence , and to obtain information on relative caries preventive efficacy . Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel . Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily . The study was conducted as a single-blinded , parallel-cell trial . Pre-existing carious lesions were restored prior to the beginning of the study . The efficacy variable was determined by the mean number of new or recurrent decayed surfaces . Patients were examined for caries 4 , 8 , 12 , 24 , 36 , and 48 weeks after initiation of treatment . Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews . At baseline , the resting and stimulated salivary flow rates ( g/5min ) were significantly greater in the control group than in the study group ( p < 0.05 ) . Patients in the control group had received significantly more radiation than those in the test group ( 68Gy vs. 60Gy ; p=0.047 ) . No marked differences in follow-up new and recurrent caries were found between the stannous fluoride gel control and IFRS groups during the study period . The rate of new or recurrent carious lesions in the group treated with the fluoride gel was slightly lower than in the IFRS group , based on carious lesions at the baseline examination ( Poisson mean number of new or recurrent carious lesions for the control group=0.55 per year vs. 0.83 per year for the study group , p=0.705 ; odds ratio of the occurrence of any new or recurrent caries during follow-up for control group vs. the study group=0.80 ; p=0.781 ) . This pilot study revealed that the IFRS was well-tolerated and safe in this study population associated with minimal complications during the duration of this study and was comparable in efficacy to a SnF ( 2 ) gel in preventing caries development . The IFRS provided similar rates of control for caries formation to a fluoride-gel-containing tray . The IFRS is designed to release a daily dose of 0.12mg of sodium fluoride , which can be evenly distributed throughout the oral cavity for a single application of 4 months . It would be more convenient than the daily home application of a tray of 0.4 % stannous fluoride or 1.1 % sodium fluoride gel , and avoids the problem of variable patient compliance .
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Intervention_Physical
intraoral fluoride releasing system
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Intervention_Control
fluoride-gel-containing tray
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Intervention_Pharmacological
sodium fluoride
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Outcome_Physical
recurrent caries
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Outcome_Physical
rate of new or recurrent carious lesions in the group
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Outcome_Physical
odds ratio of the occurrence of any new or recurrent caries
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Outcome_Other
well-tolerated and safe
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Outcome_Adverse-effects
complications
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Outcome_Other
efficacy to a SnF ( 2 ) gel
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Outcome_Other
rates of control
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Participant_Condition
radiation-induced xerostomic subjects .
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Participant_Sample-size
Twenty-two head and neck cancer patients from U.
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Participant_Condition
Patients in both groups
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Participant_Condition
Patients in the control group