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NCT06063239
Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
NA trial testing Test Group in Tooth Decay in 70 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | G. d'Annunzio University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 1 October 2023 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Test Group
- Positive Control — full drug profile →
- Negative Control — full drug profile →
Conditions studied
- Tooth Decay — all drugs for Tooth Decay →
- Intellectual Disability — all drugs for Intellectual Disability →
- Caries,Dental — all drugs for Caries,Dental →
Sponsor
G. d'Annunzio University
Who can join
10 and older, any sex, with Tooth Decay or Intellectual Disability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06063239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06063239 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by G. d'Annunzio University
- Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06063239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing