Intellectual Disability Clinical Trial
Official title:
Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
The goal of this randomized clinical trial is to test the effect orally administration of Probiotics based on Lactobacillus rhamnosus LR04 and Lactobacillus plantarum LP14 as adjuvant in caries prevention in subjects who can not properly perform oral hygiene procedures. The main questions it aims to answer are: - QUESTION 1: orally administered probiotics based on the previous strains could represent a useful tool in support of special needs patients in tooth decay prevention? - QUESTION 2: orally administered probiotics based on the previous strains could ameliorate salivary pH management? Partecipants in the test group will take the test probiotic for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the positive controlled group will take the placebo for 90 days in adjunction of the routinary oral hygiene procedures. Partecipants in the negative control group will perform only the routinary oral hygiene procedures. Researchers will compare 3 groups to see if orally administered probiotics based on L. rhamnosus and L. plantarum may help in the management of clinical status and salivary pH levels.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | May 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - individuals with intellectual disability in presence of gingivitis in 1 quadrant at least and 1 decayed tooth at least, and improper oral hygiene routine. Exclusion Criteria: - individuals without intellectual disability or with the condition in absence of gingivitis, decayed teeth and improper oral hygiene routine. |
Country | Name | City | State |
---|---|---|---|
Italy | University G. d'Annunzio | Chieti |
Lead Sponsor | Collaborator |
---|---|
G. d'Annunzio University |
Italy,
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Petrovic BB, Peric TO, Markovic DLJ, Bajkin BB, Petrovic D, Blagojevic DB, Vujkov S. Unmet oral health needs among persons with intellectual disability. Res Dev Disabil. 2016 Dec;59:370-377. doi: 10.1016/j.ridd.2016.09.020. Epub 2016 Sep 30. — View Citation
Porksen CJ, Keller MK, Damholt A, Frederiksen AKS, Ekstrand KR, Markvart M, Larsen T, Bakhshandeh A. The effect of a lozenge combining prebiotic arginine and probiotics on caries increment in children during 10-12 months, a randomized clinical trial. J Dent. 2023 Aug;135:104599. doi: 10.1016/j.jdent.2023.104599. Epub 2023 Jun 24. — View Citation
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of clinical dicotomic indexes for gingivitis | Gingivitis will be recorded for each quadrant as present/absent taking into account the classical flogistic signs. | From enrollement to the end of treatment at 3 months. | |
Secondary | management of salivary pH | Salivary pH will be recorded via digital pHmeter 3/times for each time-point in order to minimaze the error of registration. | From enrollement to the end of treatment at 3 months. |
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