Dental Caries in ChildrenNCT04929340
Prevention of Recurrent Caries With Lactobacilli PRECAL
A study testing Probiotic bacteria in people with Dental Caries in Children, run by Umeå University at 3 sites in Sweden.
Trial summary
The aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Probiotic bacteria
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesSweden
- Study dates
- 1 May 2017to 1 Dec 2021
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preschool children, 2-5 year of age
- with Early childhood caries (ECC) or
- severe Early childhood caries (S-ECC)
- scheduled for restorations and extractions under general anesthesia or any form of sedation
- The obligate requirement is that the child should be fully treated and managed with aspect to caries within a period of not more than two months.
Who cannot join
- medically comprised children
- children with severe cognitive problems or dysfunctional families
- families planning to relocate within the next year
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Barntandvården Halmstad
Halmstad, 301 85
Eastmaninstitutet Pedodonti, Stockholm
Stockholm, 10231
Tandläkarhögskolan Umeå
Umeå, 901 85
About this study
Official title: Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
The aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or conscious sedation. The project will be conducted at three specialist centers (Umeå University, Umeå, Sweden, Maxillo-facial unit, Halmstad Hospital, Sweden; Eastman Institute, Stockholm, Sweden) and employ a randomized placebo-controlled design with two parallel arms. The study will be performed double-blind and neither the parents nor the clinicians will be aware of the content of the drops. The follow-up period is one year.
- Conditions
- Dental Caries in Children
- Being tested
- Probiotic bacteria, Placebo
- Keywords
- Early childhood caries, Probiotic bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic bacteriaOther
Also called Experimental
The children are randomly allocated to a test or a control group with aid of computer-generated numbers at the time of consent. After the treatment, children in the test group are given 5 drops per day containing probiotic bacteria (Lactobacillus reuteri Protectis DSM 17938, Biogaia AB, Sweden) before bedtime. One dose consists of a minimum of 100 million live bacteria. Children in control group are given 5 drops per day (containing no bacteria).
PlaceboOther
Children in control group are given 5 drops per day (containing no bacteria).
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 5 drops each day before bedtime but after toothbrushing. L. reuteri DSM 17938, L. reuteri ATCC PTA 5289, with a minimum of 100 million live bacteria of each strain. Receives: Other: Probiotic bacteria |
| placebo | Placebo comparator | 5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental caries
dental caries (International Caries Detection and Assesment System, ICDAS level)
Measured: 6 months
dental caries
dental caries (International Caries Detection and Assesment System, ICDAS level)
Measured: 12 months
Secondary outcomes (2)
visible supra-gingival plaque
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)
Measured: 6 months
visible supra-gingival plaque
presence of visible supragingival plaque on buccal surfaces upper anterior teeth (yes/no)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 May 2017
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: recruitment on hold since spring 2020 due to Covid-19 pandemic
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 Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by Umeå 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Hasselof, Umeå University
- Investigators
- Pamela Hasslöf, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929340
- Sponsor's protocol ID
- OD5.1-8-17
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasslof P, Granqvist L, Stecksen-Blicks C, Twetman S. Prevention of Recurrent Childhood Caries with Probiotic Supplements: A Randomized Controlled Trial with a 12-Month Follow-Up. Probiotics Antimicrob Proteins. 2022 Apr;14(2):384-390. doi: 10.1007/s12602-022-09913-9. Epub 2022 Jan 26.
PubMed 35083729
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04929340
- Acronym / sponsor ID
- OD5.1-8-17
- Conditions
- Dental Caries in Children
- Keywords
- Early childhood caries, Probiotic bacteria
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: recruitment on hold since spring 2020 due to Covid-19 pandemic
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 18 Jun 2021 (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 aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or conscious sedation. The project will be conducted at three specialist centers (Umeå University, Umeå, Sweden, Maxillo-facial unit, Halmstad Hospital, Sweden; Eastman Institute, Stockholm, Sweden) and employ a randomized placebo-controlled design with two parallel arms. The study will be performed double-blind and neither the parents nor the clinicians will be aware of the content of the drops. The follow-up period is one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Other: Probiotic bacteria5 drops each day before bedtime but after toothbrushing. L. reuteri DSM 17938, L. reuteri ATCC PTA 5289, with a minimum of 100 million live bacteria of each strain. |
| placebo | Placebo comparator | Other: Placebo5 drops each day before bedtime but after toothbrushing. The placebo drops had identical composition color and taste but no probiotic bacteria. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preschool children, 2-5 year of age
- with Early childhood caries (ECC) or
- severe Early childhood caries (S-ECC)
- scheduled for restorations and extractions under general anesthesia or any form of sedation
- The obligate requirement is that the child should be fully treated and managed with aspect to caries within a period of not more than two months.
Key exclusion criteria (3 listed)
- medically comprised children
- children with severe cognitive problems or dysfunctional families
- families planning to relocate within the next year
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 |
|---|---|---|
| Probiotic bacteriaAlso: ExperimentalThe children are randomly allocated to a test or a control group with aid of computer-generated numbers at the time of consent. After the treatment, children in the test group are given 5 drops per day containing probiotic bacteria (Lactobacillus reuteri Protectis DSM 17938, Biogaia AB, Sweden) before bedtime. One dose consists of a minimum of 100 million live bacteria. Children in control group are given 5 drops per day (containing no bacteria). | Other | experimental |
| PlaceboChildren in control group are given 5 drops per day (containing no bacteria). | Other | placebo |
Primary outcome
dental caries
Time frame: 6 months
dental caries (International Caries Detection and Assesment System, ICDAS level)
dental caries
Time frame: 12 months
dental caries (International Caries Detection and Assesment System, ICDAS level)
2 secondary outcomes
visible supra-gingival plaque
Time frame: 6 months
visible supra-gingival plaque
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Derived from this study: PubMed 35083729Hasslof P, Granqvist L, Stecksen-Blicks C, Twetman S. Prevention of Recurrent Childhood Caries with Probiotic Supplements: A Randomized Controlled Trial with a 12-Month Follow-Up. Probiotics Antimicrob Proteins. 2022 Apr;14(2):384-390. doi: 10.1007/s12602-022-09913-9. Epub 2022 Jan 26.
- Individual participant dataSharing planned: No
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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.
Pamela Hasslöf principal investigator
Umeå University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic bacteria in people with Dental Caries in Children, run by Umeå University at 3 sites 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 5 inclusion and 3 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: paused, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
dental caries (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04929340, 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 21 Jun 2021.