Dental PlaqueNCT06751979
Probiotic Treatment of Orthodontic Patients
A study testing Probiotic treatment in people with Dental Plaque and Dental Caries, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Dental Caries
- What is being tested?
- Probiotic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Generally healthy males and females ≥ 10 years of age.
- Able to read and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth.
- Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw > 6 months.
- An average plaque score of > 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
Who cannot join
- Significant oral soft tissue pathology based on a visual examination.
- History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- History of allergies to milk proteins.
- History of allergies towards probiotics.
- Self-reported as pregnant or nursing.
- Self-reported serious medical conditions.
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- Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- Acute sinusitis or severe oral-pharyngeal infections.
- Smoker.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University, Department of Dentistry and Oral Health
Aarhus, 8000
Sebastian Schlafer, Dr., +45-87167451, sebastians@dent.au.dk
Elisabeth Reichardt, Dr., 17620130691 ext. 49, elisabeth.reichardt@dent.au.dk
About this study
Official title: Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.
The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.
- Conditions
- Dental Plaque, Dental Caries
- Being tested
- Probiotic treatment, Placebo
- Medical subject headings
- Dental Plaque, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic treatmentDietary supplement
Daily intake of a lozenge containing the probiotic strain S. salivarius M18.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Not described Receives: Dietary Supplement: Probiotic treatment |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Planimetric plaque quantification
Amount of dental plaque formed after 6 weeks of probiotic treatment
Measured: 6 weeks
Secondary outcomes (3)
Prevalence of S. salivarius
The prevalence and abundance of S. salivarius M18 in saliva, tongue coating and dental plaque samples, as determined by 16S rRNA gene sequencing
Measured: Immediately after intervention
Gingivitis
Gingivitis, as determined by the modified gingival index (MGI) and the sulcus bleeding index (SBI)
Measured: Immediately after intervention
Plaque pH
The acidogenic potential of dental plaque, as determined by pH ratiometry
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start2 Oct 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Bluestone Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751979
- Sponsor's protocol ID
- 1-10-72-77-24
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06751979
- Acronym / sponsor ID
- 1-10-72-77-24
- Conditions
- Dental Plaque, Dental Caries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Bluestone Pharma
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Dec 2024 (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 purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic treatment |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Generally healthy males and females ≥ 10 years of age.
- Able to read and receive a copy of the signed informed consent form.
- Have at least 20 natural teeth.
- Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw > 6 months.
- An average plaque score of > 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
Key exclusion criteria (9 listed)
- Significant oral soft tissue pathology based on a visual examination.
- History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- History of allergies to milk proteins.
- History of allergies towards probiotics.
- Self-reported as pregnant or nursing.
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 treatmentDaily intake of a lozenge containing the probiotic strain S. salivarius M18. | Dietary supplement | Probiotic |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Planimetric plaque quantification
Time frame: 6 weeks
Amount of dental plaque formed after 6 weeks of probiotic treatment
3 secondary outcomes
Prevalence of S. salivarius
Time frame: Immediately after intervention
Gingivitis
Time frame: Immediately after intervention
Plaque pH
Time frame: Immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
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Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
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The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
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Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic treatment in people with Dental Plaque and Dental Caries, run by University of Aarhus at 1 site in Denmark.
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 9 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Schlafer, DDS (42976020 ext. +45, sebastians@dent.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Planimetric plaque quantification (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.