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Search / Trial NCT04634201

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Launched by UNIVERSITY HOSPITAL, LILLE · Nov 16, 2020

Trial Information

Current as of July 21, 2025

Unknown status

Keywords

Gingivitis Oral Microbiota Salivary Biomarkers Probiotics

ClinConnect Summary

This clinical trial is studying the effect of probiotics on gum health in teenagers who have braces or other fixed orthodontic devices. Many teens with these devices experience gum inflammation, known as gingivitis, because braces can make it harder to keep teeth clean. The researchers want to see if taking a probiotic (a type of beneficial bacteria) along with regular tooth brushing can help reduce gum inflammation and improve the health of the mouth.

To participate in the study, teens aged 12 to 16 who are in good health and have braces can join if they have permission from their parents. Participants will be randomly assigned to either receive the probiotic or a placebo (a non-active treatment) for some time. Throughout the trial, researchers will monitor their gum health and the bacteria in their mouths. It's important to note that some teens may not qualify if they have certain health conditions, allergies, or have recently used other probiotics or mouthwashes. This study aims to provide more information on how probiotics can help prevent gum diseases in young people with braces.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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)

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Lille, , France

Patients applied

0 patients applied

Trial Officials

Kevimy AGOSSA

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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