Dental CariesNCT04593017
On Probiotic, Dental Caries, and Orthodontic Patients
A study testing Active Probiotic in people with Dental Caries, run by Göteborg University at 1 site in Sweden.
Trial summary
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ? Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Active Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2020to 21 Dec 2020
- 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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects undergoing bimaxillary fixed orthodontic treatment
- Number of S. mutans counts (>10.000 CFU/ml)
- Permanent dentition
- 3-12 months into the treatment (study from Sweden by Andrea)
- Medically healthy
- Not taking any medication
- Ability to understand the nature of the study and sign the consent form
Who cannot join
- Cleft lip and palate patients as well as handicapped and patients with mental impairments
- Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
- History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
- Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
- Habitual consumers of xylitol chewing gums
- No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?
Read the detailed description
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.
The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.
This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered
- Conditions
- Dental Caries
- Being tested
- Active Probiotic, Placebo Probiotic
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ProbioticDietary supplement
Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659
Placebo ProbioticOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active Probiotic | Experimental | Probiotic contain active microorganism Receives: Dietary Supplement: Active Probiotic |
| Placebo Probiotic | Placebo comparator | Probiotic with no active microorganism Receives: Other: Placebo Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
Changes in the plaque pH (acidic or alkaline) is an important factor among others in the cares process, in which an acidic environment will help the bacteria to accumulate along the tooth surface and starting the caries lesions.
So, considering the plaque pH as a clinical variable to show the probiotic effect is considered to be of great value.
Measured: 3 weeks
Secondary outcomes (2)
Effect of Probiotics on Dental plaque
Plaque is an important aspect in caries detection, so the change in the plaque sample will show if the probiotic will help in the caries prevention during orthodontic treatment.
Measured: 3 weeks
Effect of Probiotics on Saliva
The saliva composition which includes cariogenic bacteria (caries initiating bacteria) such as Streptococcus mutans and lactobacilli, is an important factor in caries detection, so saliva sample will show if the probiotic is helpful in caries prevention?
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion21 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups matched in age and gender
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593017
- Sponsor's protocol ID
- 260-20
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This research planned for publication
Publications
Alforaidi S, Bresin A, Almosa N, Lehrkinder A, Lingstrom P. Effect of drops containing Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) on plaque acidogenicity and other caries-related variables in orthodontic patients. BMC Microbiol. 2021 Oct 6;21(1):271. doi: 10.1186/s12866-021-02310-2.
PubMed 34615458
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT04593017
- Acronym / sponsor ID
- 260-20
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 19 Oct 2020 (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.
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?
Detailed description
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.
The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.
This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups matched in age and gender
| Arm | Type | Receives |
|---|---|---|
| Active Probiotic | Experimental | Dietary Supplement: Active ProbioticProbiotic contain active microorganism |
| Placebo Probiotic | Placebo comparator | Other: Placebo ProbioticProbiotic with no active microorganism |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Subjects undergoing bimaxillary fixed orthodontic treatment
- Number of S. mutans counts (>10.000 CFU/ml)
- Permanent dentition
- 3-12 months into the treatment (study from Sweden by Andrea)
- Medically healthy
Key exclusion criteria (6 listed)
- Cleft lip and palate patients as well as handicapped and patients with mental impairments
- Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
- History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
- Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
- Habitual consumers of xylitol chewing gums
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 |
|---|---|---|
| Active ProbioticLactobacillus Reuteri (DSM 17938 and ATCC PTA 4659 | Dietary supplement | Active Probiotic |
| Placebo ProbioticPlacebo | Other | Placebo Probiotic |
Primary outcome
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
Time frame: 3 weeks
Changes in the plaque pH (acidic or alkaline) is an important factor among others in the cares process, in which an acidic environment will help the bacteria to accumulate along the tooth surface and starting the caries lesions. So, considering the plaque pH as a clinical variable to show the probiotic effect is considered to be of great value.
2 secondary outcomes
Effect of Probiotics on Dental plaque
Time frame: 3 weeks
Effect of Probiotics on Saliva
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 34615458Alforaidi S, Bresin A, Almosa N, Lehrkinder A, Lingstrom P. Effect of drops containing Lactobacillus reuteri (DSM 17938 and ATCC PTA 5289) on plaque acidogenicity and other caries-related variables in orthodontic patients. BMC Microbiol. 2021 Oct 6;21(1):271. doi: 10.1186/s12866-021-02310-2.
- Individual participant dataSharing planned: Yes. This research planned for publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Probiotic in people with Dental Caries, run by Göteborg University at 1 site in Sweden.
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 7 inclusion and 6 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 19 Oct 2020. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients. (time frame: 3 weeks). 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 NCT04593017, which also lists 1 linked publication.
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 19 Oct 2020.