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NCT04606186
Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment in Adult Patients
NA trial testing Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) in Gingivitis in 34 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | University of Erlangen-Nürnberg |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 34 |
| Start date | 19 October 2020 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)
- Placebo-lozenges (BioGaia)
Conditions studied
- Gingivitis — all drugs for Gingivitis →
- Periodontal Inflammation — all drugs for Periodontal Inflammation →
- Orthodontic Appliance Complication — all drugs for Orthodontic Appliance Complication →
Sponsor
University of Erlangen-Nürnberg
Who can join
18 and older, any sex, with Gingivitis or Periodontal Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Orthodontic treatment with fixed appliances can be necessary to correct malocclusions in adolescence or adulthood. It its known that orthodontic treatment induces aseptic pseudo-inflammatory reactions. However, studies could show that an increase of certain inflammatory cytokines during orthodontic treatment correlated with a higher risk of root resorption. Moreover, it has been shown that orthodontic treatment leads to a dysbiosis of the oral microbiome especially during the first 3 months of the orthodontic treatment. This could be a potential risk factor as the inflammation of periodontitis during an orthodontic treatment could favor root resorption and progressive destruction of the periodontal apparatus. Probiotics are already used successfully as an adjuvant therapy in the treatment of periodontitis to improve clinical parameters and to reduce local inflammation. However, there are only a few studies that investigated the influence of probiotics during an orthodontic treatment. Therefore, the aim of our study is to investigate if the daily intake of lozenges containing probiotics versus placebo lozenges during the first 3 months of orthodontic treatment with fixed appliances can improve clinical parameters, reduce local inflammation, systemic inflammation and prevent a dysbiosis of the oral microbiome.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Influence of probiotics on the periodontium, the oral microbiota and the immune response during orthodontic treatment in adolescent and adult patients (ProMB Trial): study protocol for a prospective, double-blind, controlled, randomized clinical trial.
Seidel CL, Gerlach RG, Weider M, Wölfel T, et al · · 2022 · cited 12× · PMID 35477563 · DOI 10.1186/s12903-022-02180-8
Verify or expand the search:
- PubMed search for NCT04606186
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)
Trials testing the same drug.
- NCT04598633 — Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatmen · NA · unknown
Other recruiting trials for Gingivitis
Currently open trials in the same condition.
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- NCT07499596 — Effect of Morus Nigra Mouthwash on Gingivitis Treatment · NA · recruiting
- NCT07270705 — Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis · NA · recruiting
- NCT07164989 — Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients · NA · active not recruiting
- NCT07530978 — ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE · recruiting
Other University of Erlangen-Nürnberg trials
Trials by the same sponsor.
- NCT05817396 — Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care · NA · unknown
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- NCT05081258 — Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate · NA · recruiting
- NCT04598633 — Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatmen · NA · unknown
- NCT04367389 — Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04606186 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Erlangen-Nürnberg
- Last refreshed: 18 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04606186.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing