Tooth DecayNCT06063239
Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
A study testing Test Group in people with Tooth Decay and Intellectual Disability, run by G. d'Annunzio University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Tooth Decay, Intellectual Disability, Caries,Dental
- What is being tested?
- Test Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- individuals with intellectual disability in presence of gingivitis in 1 quadrant at least and 1 decayed tooth at least, and improper oral hygiene routine.
Who cannot join
- individuals without intellectual disability or with the condition in absence of gingivitis, decayed teeth and improper oral hygiene routine.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University G. d'Annunzio
Chieti, 66100
Marco Dolci, MD DDS PHD, +393281665925, marco.dolci@unich.it
Silvia D'Agostino, DDS PHD, +393930246351, silvia.dagostino@unich.it
About this study
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?
Read more
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.
Read the detailed 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.
- Conditions
- Tooth Decay, Intellectual Disability, Caries,Dental
- Being tested
- Test Group, Positive Control, Negative Control
- Keywords
- caries;, tooth decay, intellectual disability, probiotics, lactobacillus rhamnosus, lactobacillus plantarum, pH
- Medical subject headings
- Dental Caries, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test GroupOther
Subjects will receive orally administred probiotics based on L. plantarum and L. rhamnosus for 90 days
Positive ControlOther
Subjects will receive orally administred probiotics based on placebo 90 days
Negative ControlOther
Subjects will receive esclusively instruction to perform oral hygiene procedures properly.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Positive Control |
| Negative Control | Other | Subjects who will receive esclusively the instruction of their care-giver regarding oral hygiene procedures. Receives: Other: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of clinical dicotomic indexes for gingivitis
Gingivitis will be recorded for each quadrant as present/absent taking into account the classical flogistic signs.
Measured: From enrollement to the end of treatment at 3 months.
Secondary outcomes (1)
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.
Measured: From enrollement to the end of treatment at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tooth DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Marco Dolci, G. d'Annunzio University
- Investigators
- Marco Dolci, MD DDS PHD, Principal investigator, University G. d'Annunzio of Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063239
- Sponsor's protocol ID
- CARIES
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision regarding IPD sharing has not been made yet because a dedicated website is not available at the momente.
Publications
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.
PubMed 31729967Mac 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.
PubMed 32439304Minihan PM, Morgan JP, Park A, Yantsides KE, Nobles CJ, Finkelman MD, Stark PC, Must A. At-home oral care for adults with developmental disabilities: a survey of caregivers. J Am Dent Assoc. 2014 Oct;145(10):1018-25. doi: 10.14219/jada.2014.64.
PubMed 25270700Waldron 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.
PubMed 31149734Molina 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.
PubMed 36389277Petrovic 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.
PubMed 27697655Al-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.
PubMed 26208074Nqcobo 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.
PubMed 23951782Uwayezu 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.
PubMed 32952837Jang 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.
PubMed 37674399Butt 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.
PubMed 37670134Teanpaisan 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.
PubMed 37455386Porksen 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.
PubMed 37356561Meng 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.
PubMed 36890746Zeng 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.
PubMed 35392605
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Special Needs Patients at High Risk for Tooth Decay: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06063239
- Acronym / sponsor ID
- CARIES
- Conditions
- Tooth Decay, Intellectual Disability, Caries,Dental
- Keywords
- caries;, tooth decay, intellectual disability, probiotics, lactobacillus rhamnosus, lactobacillus plantarum, pH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Other: Test GroupSubjects 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. |
| Positive Control | Active comparator | Other: Positive ControlSubjects 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. |
| Negative Control | Other | Other: Negative ControlSubjects who will receive esclusively the instruction of their care-giver regarding oral hygiene procedures. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- individuals with intellectual disability in presence of gingivitis in 1 quadrant at least and 1 decayed tooth at least, and improper oral hygiene routine.
Key exclusion criteria (1 listed)
- individuals without intellectual disability or with the condition in absence of gingivitis, decayed teeth and improper oral hygiene routine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test GroupSubjects will receive orally administred probiotics based on L. plantarum and L. rhamnosus for 90 days | Other | Test Group |
| Positive ControlSubjects will receive orally administred probiotics based on placebo 90 days | Other | Positive Control |
| Negative ControlSubjects will receive esclusively instruction to perform oral hygiene procedures properly. | Other | Negative Control |
Primary outcome
Reduction of clinical dicotomic indexes for gingivitis
Time frame: From enrollement to the end of treatment at 3 months.
Gingivitis will be recorded for each quadrant as present/absent taking into account the classical flogistic signs.
1 secondary outcome
management of salivary pH
Time frame: From enrollement to the end of treatment at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Background: PubMed 31729967Wilson 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.
- Background: PubMed 32439304Mac 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.
- Background: PubMed 25270700Minihan PM, Morgan JP, Park A, Yantsides KE, Nobles CJ, Finkelman MD, Stark PC, Must A. At-home oral care for adults with developmental disabilities: a survey of caregivers. J Am Dent Assoc. 2014 Oct;145(10):1018-25. doi: 10.14219/jada.2014.64.
- Background: PubMed 31149734Waldron 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.
- Background: PubMed 36389277Molina 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.
- Background: PubMed 27697655Petrovic 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.
- Background: PubMed 26208074Al-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.
- Background: PubMed 23951782Nqcobo 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.
- Background: PubMed 32952837Uwayezu 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.
- Background: PubMed 37674399Jang 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.
- Background: PubMed 37670134Butt 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.
- Background: PubMed 37455386Teanpaisan 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.
- Individual participant dataSharing planned: No. A decision regarding IPD sharing has not been made yet because a dedicated website is not available at the momente.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Dolci, MD DDS PHD principal investigator
University G. d'Annunzio of Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Group in people with Tooth Decay and Intellectual Disability, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Dolci, MD DDS PHD (+393281665925, marco.dolci@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of clinical dicotomic indexes for gingivitis (time frame: From enrollement to the end of treatment at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06063239, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.