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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04634201
Other study ID # 2019_14
Secondary ID 2020-A02179-30
Status Recruiting
Phase N/A
First received
Last updated
Start date March 23, 2022
Est. completion date March 2024

Study information

Verified date February 2023
Source University Hospital, Lille
Contact Kevimy AGOSSA, MD
Phone 0320445962
Email kevimy.agossa@univ-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 16 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Oral probiotics (L. reuteri)
administration of probiotic containing tablets twice daily after tooth brushing for 3 months
Placebo
administration of a placebo twice daily after tooth brushing for 3 months

Locations

Country Name City State
France Hop Salengro - Chu Lille Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Sunstar, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of gingival index (Löe Silness) between baseline and 6 months At 6 months
Secondary bleeding on probing (BOP) score (% of BOP sites) At Baseline, at 3 months and 6 months
Secondary plaque index (O'leary) At Baseline, at 3 months and 6 months
Secondary dysbiosis index Shannon-weaver, alpha rarefaction, beta diversity At Baseline, at 3 months and 6 months
Secondary level of salivary markers of inflammation - At Baseline, at 3 months and 6 months
Secondary compliance level record At Baseline, at 3 months and 6 months
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