NCT04634201 Effect of Probiotics on the Periodontal Status of Orthodontic Patients
| NCT ID | NCT04634201 |
| Status | Terminated |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Periodontal Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2022-03-23 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2022-03-23 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
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)
Contact & Investigator
Kevimy AGOSSA
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04634201 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 16 Years, studying Periodontal Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04634201 currently recruiting?
NCT04634201 is currently listed as "Terminated" and is not actively enrolling. Check ClinicalTrials.gov for the latest status updates.
Where is the NCT04634201 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04634201 clinical trial?
NCT04634201 is sponsored by University Hospital, Lille. The principal investigator is Kevimy AGOSSA at University Hospital, Lille. The trial plans to enroll 3 participants.