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

Intellectual Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06063239
• Other study ID #: CARIES
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2023
• Source: G. d'Annunzio University
• Contact: Marco Dolci, MD DDS PHD
• Phone: +393281665925
• Email: marco.dolci[@]unich.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

BASELINE - T0. Signature of informed consent. Completion of a specific questionnaire regarding consumption of simple sugars and initial home oral hygiene procedures. Oral cavity inspection with registration of gingivitis according to dichotomous qualitative indices by quadrants.Recording of specific parameters: Salivary pH via GEASS® pH meter. DMFT (Decayed Missing Filled Teeth).

Random placement of the patient in the test, positive or negative control group.

TEST: instruction of the subject and/or caregiver in home oral hygiene 2/day + oeally administred probiotic based on L. plantarum and L. rhamnosus for 90 days.

POSITIVE CONTROL: instruction of the subject and/or caregiver in home oral hygiene 2/day + orally administred placebo.

NEGATIVE CONTROL: instruction of the subject and/or caregiver for home oral hygiene procedures 2/day.

T1 - AFTER 3 MONTHS FROM T0. Oral cavity inspection with recording of gingivitis according to dichotomous qualitative indices by quadrants. Recording of pH and DMFT.

Randomization. The treatment that is due to the individual patient is kept in sequentially numbered, opaque and sealed envelopes (SNOSE Sequentially Numbered, Opaque, Sealed Envelopes). The products used for both the test and the controls will be supplied in anonymous tubes so that neither the patient nor the investigator will be aware of them.

Statistical analysis: Developed by trusted bioinformatics group.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries
• Intellectual Disability
• Tooth Decay

Intervention

Other:
• Test Group
Subjects will receive orally administred probiotics based on L. plantarum and L. rhamnosus for 90 days
• Positive Control
Subjects will receive orally administred probiotics based on placebo 90 days
• Negative Control
Subjects will receive esclusively instruction to perform oral hygiene procedures properly.

Locations

Country	Name	City	State
Italy	University G. d'Annunzio	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

References & Publications (19)

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Gonczi NN, Strang O, Bagi Z, Rakhely G, Kovacs KL. Interactions between probiotic and oral pathogenic strains. Biol Futur. 2021 Dec;72(4):461-471. doi: 10.1007/s42977-021-00091-3. Epub 2021 Jun 2. — View Citation

Jang HJ, Kim JH, Lee NK, Paik HD. Probiotic Lactobacillus plantarum Ln4 Showing Antimicrobial and Antibiofilm Effect against Streptococcus mutans KCTC 5124 Causing Dental Caries. J Microbiol Biotechnol. 2023 Sep 8;33(12):1-10. doi: 10.4014/jmb.2306.06001. Online ahead of print. — View Citation

Jung HY, Cai JN, Yoo SC, Kim SH, Jeon JG, Kim D. Collagen Peptide in a Combinatorial Treatment with Lactobacillus rhamnosus Inhibits the Cariogenic Properties of Streptococcus mutans: An In Vitro Study. Int J Mol Sci. 2022 Feb 7;23(3):1860. doi: 10.3390/ijms23031860. — View Citation

Mac Giolla Phadraig C, Farag M, McCallion P, Waldron C, McCarron M. The complexity of tooth brushing among older adults with intellectual disabilities: Findings from a nationally representative survey. Disabil Health J. 2020 Oct;13(4):100935. doi: 10.1016/j.dhjo.2020.100935. Epub 2020 May 11. — View Citation

Meng N, Liu Q, Dong Q, Gu J, Yang Y. Effects of probiotics on preventing caries in preschool children: a systematic review and meta-analysis. J Clin Pediatr Dent. 2023 Mar;47(2):85-100. doi: 10.22514/jocpd.2023.014. Epub 2023 Mar 3. — View Citation

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Molina G, Zar M, Dougall A, McGrath C. Management of dental caries lesions in patients with disabilities: Update of a systematic review. Front Oral Health. 2022 Oct 28;3:980048. doi: 10.3389/froh.2022.980048. eCollection 2022. — View Citation

Nqcobo CB, Yengopal V, Rudolph MJ, Thekiso M, Joosab Z. Dental caries prevalence in children attending special needs schools in Johannesburg, Gauteng Province, South Africa. SADJ. 2012 Aug;67(7):308-13. — View Citation

Pahumunto N, Piwat S, Chanvitan S, Ongwande W, Uraipan S, Teanpaisan R. Fermented milk containing a potential probiotic Lactobacillus rhamnosus SD11 with maltitol reduces Streptococcus mutans: A double-blind, randomized, controlled study. J Dent Sci. 2020 Dec;15(4):403-410. doi: 10.1016/j.jds.2020.03.003. Epub 2020 May 6. — View Citation

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

Tahmourespour A, Kasra-Kermanshahi R, Salehi R. Lactobacillus rhamnosus biosurfactant inhibits biofilm formation and gene expression of caries-inducing Streptococcus mutans. Dent Res J (Isfahan). 2019 Mar-Apr;16(2):87-94. — View Citation

Teanpaisan R, Surachat K, Wonglapsuwan M, Piwat S, Pahumunto N. Short-term use of Lacticaseibacillus rhamnosus SD11 and the oral microbiome: Low caries RCT study. Oral Dis. 2023 Jul 16. doi: 10.1111/odi.14681. Online ahead of print. — View Citation

Uwayezu D, Gatarayiha A, Nzayirambaho M. Prevalence of dental caries and associated risk factors in children living with disabilities in Rwanda: a cross-sectional study. Pan Afr Med J. 2020 Jul 17;36:193. doi: 10.11604/pamj.2020.36.193.24166. eCollection 2020. — View Citation

Waldron C, Nunn J, Mac Giolla Phadraig C, Comiskey C, Guerin S, van Harten MT, Donnelly-Swift E, Clarke MJ. Oral hygiene interventions for people with intellectual disabilities. Cochrane Database Syst Rev. 2019 May 31;5(5):CD012628. doi: 10.1002/14651858.CD012628.pub2. — View Citation

Wilson NJ, Lin Z, Villarosa A, Lewis P, Philip P, Sumar B, George A. Countering the poor oral health of people with intellectual and developmental disability: a scoping literature review. BMC Public Health. 2019 Nov 15;19(1):1530. doi: 10.1186/s12889-019-7863-1. — View Citation

Zeng Y, Fadaak A, Alomeir N, Wu TT, Rustchenko E, Qing S, Bao J, Gilbert C, Xiao J. Lactobacillus plantarum Disrupts S. mutans-C. albicans Cross-Kingdom Biofilms. Front Cell Infect Microbiol. 2022 Mar 22;12:872012. doi: 10.3389/fcimb.2022.872012. eCollection 2022. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

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.