Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.

Recent literature has highlighted how patients' oral health is closely linked to the presence of intellectual and developmental disabilities (IDD). It has in fact been found that in patients with IDD the level of oral health tends to be lower than in subjects without IDD, and how this has an influence on the general state of health. A key role appears to be played by caregivers, who carry out the delicate task of maintaining an adequate level of oral hygiene. Among various aspects, daily oral hygiene maneuvers were considered as a key intervention in maintaining good health. In this regard, it is worth remembering that a study conducted in 1990 on caregivers demonstrated how, despite knowing the characteristics of the healthy appearance of the tissues supporting the dental elements, not everyone knew how this was closely related to the oral hygiene. Likewise, the study by Kilian and collaborators demonstrated how the maintenance of an oral microbiota that promotes oral health is not only desirable, but also possible. Given that the implementation of correct home hygiene represents a cornerstone in the management of general well-being, we decided to evaluate whether a formulation that allows the strengthening of bacterial populations competitive with respect to cariogenic populations could be significantly useful for the maintenance of these patients.

Inclusion criteria: adult and minor special needs patients belonging to the University Dental Clinic of Chieti. Presence of motor and/or cognitive difficulties in carrying out oral hygiene maneuvers at home.

Exclusion criteria: special needs patients with effective home hygiene.

Minimum sample size: Calculation of sample size (Alpha = 0.05; Power = 95%) for 3 independent study groups, and a continuous primary endpoint.

Sample size = Z2 (1-alpha/2) p (1-p) / d2 Where Z(1-alpha/2) is the standard variate corresponding to 1.96 at 5% type 1 error, p is the expected proportion in the population expressed in decimals based on previous studies and d is the confidence level decided by the researcher expressed in decimal. 20 patients are required per group, for a total of 60 patients. To these patients, the dropout percentage of 10% must be added, so the total is 70 patients.