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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Participants receiving probiotic supplementation during orthodontic treatment |
|
| Control | No Intervention | Participants received standard oral hygiene instruction and professional scaling without probiotic supplementation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic suplementation | Dietary Supplement | Participants received probiotic supplementation containing Limosilactobacillus reuteri during orthodontic treatment. The intervention was administered in an open-label manner without placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaźmierczyk-Winciorek | Department of Integrated Dentistry, Medical University of Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | Poland |
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| Label | URL |
|---|---|
| The immunomodulating role of probiotics in the prevention and treatment of oral diseases | View source |
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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.
Data will be available beginning 6 months after publication and will remain available for 5 years.
Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to the corresponding author. Access will be granted after review and approval of the proposal, and a data access agreement may be required.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2022 | Apr 19, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 2, 2022 | Apr 19, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 2, 2022 | Apr 19, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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Participants were randomly assigned to parallel groups receiving and not receiving probiotics
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| D009057 |
| Stomatognathic Diseases |