GingivitisPRO-ORTHONCT07548138
Effect of Probiotic Supplementation on Gingival Health in Orthodontic Patients
A study testing Probiotic suplementation in people with Gingivitis and Orthodontic Treatment, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study evaluated the effect of probiotic supplementation on gingival health in orthodontic patients. Participants undergoing fixed orthodontic treatment were randomly assigned to receive either a probiotic preparation containing Limosilactobacillus reuteri or no The primary objective was to assess changes in… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Gingivitis, Orthodontic Treatment
- What is being tested?
- Probiotic suplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 10 Mar 2025
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Generally healthy patient
- Age 18-59 years
- Fixed-appliance orthodontic treatment
- Plaque-induced gingivitis (BOP > 10%, PD ≤ 4 mm)
Who cannot join
- Hypersensitivity to product components
- Smoking
- Use of any probiotics within the past 30 days
- Antibiotic or other antimicrobial therapy within the past month
- Use of antibacterial chlorhexidine rinses within the past 2 weeks
- Age < 18 or > 59 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of the Probiotic Limosilactobacillus Reuteri Prodentis (DSM 17938 and ATCC PTA 5289) on Clinical and Microbiological Parameters in Orthodontically Treated Patients With Concomitant Gingivitis
This study evaluated the effect of probiotic supplementation on gingival health in orthodontic patients. Participants undergoing fixed orthodontic treatment were randomly assigned to receive either a probiotic preparation containing Limosilactobacillus reuteri or no The primary objective was to assess changes in gingival inflammation using clinical periodontal indices(BOP). Secondary outcomes included plaque accumulation(PI) . The results of this study may help determine whether probiotic supplementation can support gingival health during orthodontic treatment
Read the detailed description
This was a randomized, controlled clinical trial conducted in orthodontic patients with gingivitis. Participants were allocated to probiotic or no groups and followed for the duration of the orthodontic treatment period. Clinical periodontal parameters were recorded at baseline and at follow-up visits according to the study protocol
- Conditions
- Gingivitis, Orthodontic Treatment
- Being tested
- Probiotic suplementation
- Keywords
- Probiotics, Limosilactobacillus reuteri, Orthodontic treatment
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic suplementationDietary supplement
Participants received probiotic supplementation containing Limosilactobacillus reuteri during orthodontic treatment. The intervention was administered in an open-label manner without placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Participants receiving probiotic supplementation during orthodontic treatment Receives: Dietary Supplement: Probiotic suplementation |
| Control | No intervention | Participants received standard oral hygiene instruction and professional scaling without probiotic supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival inflammation.
Gingivitis was assessed using a standardized clinical gingival index (BOP-Bleeding On Probing) during orthodontic treatment.A result above 10 percent indicates localized gingivitis, a result above 30 percent indicates generalized gingivitis. A result below 10 percent indicates healthy periodontium.The higher the percentage value, the worse the result
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Dec 2021
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to parallel groups receiving and not receiving probiotics
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaźmierczyk-Winciorek, Study chair, Department of Integrated Dentistry, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548138
- Sponsor's protocol ID
- WUM 1S8/1/Z/GW/N/21
- Acronym
- PRO-ORTHO
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including clinical parameters (bleeding on probing, probing depth, full-mouth plaque index) and microbiological outcomes, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of the Probiotic Limosilactobacillus Reuteri Prodentis (DSM 17938 and ATCC PTA 5289) on Clinical and Microbiological Parameters in Orthodontically Treated Patients With Concomitant Gingivitis
- ClinicalTrials.gov ID
- NCT07548138
- Acronym / sponsor ID
- PRO-ORTHO / WUM 1S8/1/Z/GW/N/21
- Conditions
- Gingivitis, Orthodontic Treatment
- Keywords
- Probiotics, Limosilactobacillus reuteri, Orthodontic treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 23 Apr 2026 (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.
This study evaluated the effect of probiotic supplementation on gingival health in orthodontic patients. Participants undergoing fixed orthodontic treatment were randomly assigned to receive either a probiotic preparation containing Limosilactobacillus reuteri or no The primary objective was to assess changes in gingival inflammation using clinical periodontal indices(BOP). Secondary outcomes included plaque accumulation(PI) . The results of this study may help determine whether probiotic supplementation can support gingival health during orthodontic treatment
Detailed description
This was a randomized, controlled clinical trial conducted in orthodontic patients with gingivitis. Participants were allocated to probiotic or no groups and followed for the duration of the orthodontic treatment period. Clinical periodontal parameters were recorded at baseline and at follow-up visits according to the study protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to parallel groups receiving and not receiving probiotics
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic suplementationParticipants receiving probiotic supplementation during orthodontic treatment |
| Control | No intervention | –Participants received standard oral hygiene instruction and professional scaling without probiotic supplementation |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Generally healthy patient
- Age 18-59 years
- Fixed-appliance orthodontic treatment
- Plaque-induced gingivitis (BOP > 10%, PD ≤ 4 mm)
Key exclusion criteria (6 listed)
- Hypersensitivity to product components
- Smoking
- Use of any probiotics within the past 30 days
- Antibiotic or other antimicrobial therapy within the past month
- Use of antibacterial chlorhexidine rinses within the past 2 weeks
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 suplementationParticipants received probiotic supplementation containing Limosilactobacillus reuteri during orthodontic treatment. The intervention was administered in an open-label manner without placebo | Dietary supplement | Probiotic group |
Primary outcome
Change in gingival inflammation.
Time frame: from baseline to 12 weeks
Gingivitis was assessed using a standardized clinical gingival index (BOP-Bleeding On Probing) during orthodontic treatment.A result above 10 percent indicates localized gingivitis, a result above 30 percent indicates generalized gingivitis. A result below 10 percent indicates healthy periodontium.The higher the percentage value, the worse the result
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- The immunomodulating role of probiotics in the prevention and treatment of oral diseasesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study, including clinical parameters (bleeding on probing, probing depth, full-mouth plaque index) and microbiological outcomes, will be shared.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Kaźmierczyk-Winciorek study chair
Department of Integrated Dentistry, Medical University of Warsaw
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 suplementation in people with Gingivitis and Orthodontic Treatment, run by Medical University of Warsaw at 1 site in Poland.
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 4 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: finished, as of the sponsor's last update on 23 Apr 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in gingival inflammation. (time frame: from baseline to 12 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 23 Apr 2026.