Periodontal HealthPOPNCT04634201
Effect of Probiotics on the Periodontal Status of Orthodontic Patients
A study testing Oral probiotics (L. reuteri) in people with Periodontal Health and Gingivitis, run by University Hospital, Lille at 1 site in France.
Trial summary
Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Periodontal Health, Gingivitis
- What is being tested?
- Oral probiotics (L. reuteri)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to 1 Mar 2026
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adolescents aged 12 to 16 benefiting from social security coverage
- in good general health in brushing and taking treatments
- Have FODs
- who consent to the study and whose parents have given their consent
- suitable for orthodontic treatment in view of his oral state
Who cannot join
- inability to obtain informed consent
- use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month before inclusion
- allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)
- no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion
- medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care)
- physiological, pathological condition, medication or behavior that may have repercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco)
- oral state requiring other priority care (untreated cavities, untreated active periodontitis, progressive recession)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances
- Conditions
- Periodontal Health, Gingivitis
- Being tested
- Oral probiotics (L. reuteri), Placebo
- Keywords
- Gingivitis, oral microbiota, salivary biomarkers, probiotics
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral probiotics (L. reuteri)Dietary supplement
administration of probiotic containing tablets twice daily after tooth brushing for 3 months
PlaceboDietary supplement
administration of a placebo twice daily after tooth brushing for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Dietary Supplement: Oral probiotics (L. reuteri) |
| control group | Sham comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of gingival index (Löe Silness) between baseline and 6 months
Measured: At 6 months
Secondary outcomes (5)
bleeding on probing (BOP) score (% of BOP sites)
Measured: At Baseline, at 3 months and 6 months
plaque index (O'leary)
Measured: At Baseline, at 3 months and 6 months
dysbiosis index
Shannon-weaver, alpha rarefaction, beta diversity
Measured: At Baseline, at 3 months and 6 months
level of salivary markers of inflammation -
Measured: At Baseline, at 3 months and 6 months
compliance level record
Measured: At Baseline, at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start23 Mar 2022
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal HealthStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar, Inc.
- Responsible party
- Sponsor
- Investigators
- Kevimy AGOSSA, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634201
- Sponsor's protocol ID
- 2019_14
- Other IDs
- 2020-A02179-30
- Acronym
- POP
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT04634201
- Acronym / sponsor ID
- POP / 2019_14
- Conditions
- Periodontal Health, Gingivitis
- Keywords
- Gingivitis, oral microbiota, salivary biomarkers, probiotics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Sunstar, Inc.
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 Nov 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.
Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Oral probiotics (L. reuteri) |
| control group | Sham comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- adolescents aged 12 to 16 benefiting from social security coverage
- in good general health in brushing and taking treatments
- Have FODs
- who consent to the study and whose parents have given their consent
- suitable for orthodontic treatment in view of his oral state
Key exclusion criteria (7 listed)
- inability to obtain informed consent
- use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month before inclusion
- allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)
- no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion
- medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care)
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 |
|---|---|---|
| Oral probiotics (L. reuteri)administration of probiotic containing tablets twice daily after tooth brushing for 3 months | Dietary supplement | Experimental group |
| Placeboadministration of a placebo twice daily after tooth brushing for 3 months | Dietary supplement | control group |
Primary outcome
Variation of gingival index (Löe Silness) between baseline and 6 months
Time frame: At 6 months
5 secondary outcomes
bleeding on probing (BOP) score (% of BOP sites)
Time frame: At Baseline, at 3 months and 6 months
plaque index (O'leary)
Time frame: At Baseline, at 3 months and 6 months
dysbiosis index
Time frame: At Baseline, at 3 months and 6 months
level of salivary markers of inflammation -
Time frame: At Baseline, at 3 months and 6 months
compliance level record
Time frame: At Baseline, at 3 months and 6 months
Results and safety
The study was stopped early (reason given: sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Kevimy AGOSSA principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral probiotics (L. reuteri) in people with Periodontal Health and Gingivitis, run by University Hospital, Lille at 1 site in France.
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 7 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: stopped early, as of the sponsor's last update on 22 May 2026. 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 France. 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?
The study was stopped early (reason given: sponsor decision). 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?
Variation of gingival index (Löe Silness) between baseline and 6 months (time frame: At 6 months). 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 22 May 2026.