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

NCT06063239 | Unknown

• 1 other identifier: CARIES
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Decay; Intellectual Disability; Caries,Dental

Keywords

caries;; tooth decay; intellectual disability; probiotics; lactobacillus rhamnosus; lactobacillus plantarum; pH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• management of salivary pH

  From enrollement to the end of treatment at 3 months.

Study Arms (3)

Test Group

EXPERIMENTAL

Subjects who will receive orally administred probiotics based on L. rhamnosus and L. plantarum for 90 days in adjunction to the instruction of their care-giver regarding oral hygiene procedures.

Other: Test Group

Positive Control

ACTIVE COMPARATOR

Subjects who will receive orally administred probiotics based on placebo for 90 days in adjunction to the instruction of their care-giver regarding oral hygiene procedures.

Other: Positive Control

Negative Control

OTHER

Subjects who will receive esclusively the instruction of their care-giver regarding oral hygiene procedures.

Other: Negative Control

Interventions

Test Group OTHER

Subjects will receive orally administred probiotics based on L. plantarum and L. rhamnosus for 90 days

Test Group

Positive Control OTHER

Subjects will receive orally administred probiotics based on placebo 90 days

Positive Control

Negative Control OTHER

Subjects will receive esclusively instruction to perform oral hygiene procedures properly.

Negative Control

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with intellectual disability in presence of gingivitis in 1 quadrant at least and 1 decayed tooth at least, and improper oral hygiene routine.

You may not qualify if:

• individuals without intellectual disability or with the condition in absence of gingivitis, decayed teeth and improper oral hygiene routine.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

University G. d'Annunzio

Chieti, 66100, Italy

Location

Related Publications (19)

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  PMID: 31149734 BACKGROUND

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  PMID: 36389277 BACKGROUND

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  PMID: 27697655 BACKGROUND

• Al-Maweri SA, Zimmer S. Oral Health Survey of 6-14-Year-Old Children with Disabilities Attending Special Schools Yemen. J Clin Pediatr Dent. 2015 Spring;39(3):272-6. doi: 10.17796/1053-4628-39.3.272.

  PMID: 26208074 BACKGROUND

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  PMID: 23951782 BACKGROUND

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  PMID: 32952837 BACKGROUND

• 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. 2024 Jan 28;34(1):116-122. doi: 10.4014/jmb.2306.06001. Epub 2023 Sep 8.

  PMID: 37674399 BACKGROUND

• Butt S, Sin M. Can probiotics prevent dental caries? Evid Based Dent. 2023 Sep;24(3):130-131. doi: 10.1038/s41432-023-00918-z. Epub 2023 Sep 5.

  PMID: 37670134 BACKGROUND

• 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. 2024 May;30(4):2736-2745. doi: 10.1111/odi.14681. Epub 2023 Jul 16.

  PMID: 37455386 BACKGROUND

• 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.

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MeSH Terms

Conditions

Dental Caries; Intellectual Disability

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Marco Dolci, MD DDS PHD

  University G. d'Annunzio of Chieti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Dolci, MD DDS PHD

CONTACT

+393281665925; marco.dolci@unich.it

Silvia D'Agostino, DDS PHD

CONTACT

+393281665925; silvia.dagostino@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: SNOSE Sequentially Numbered, Opaque, Sealed Envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD DDS PHD

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)