Clinical trial NCT04634201: Effect of Probiotics on the Periodontal Status of Orthodontic Patients
Official title: Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Health
Gingivitis
Keywords: Gingivitis
oral microbiota
salivary biomarkers
probiotics
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Sunstar, Inc.
First posted: 2020-11-18
Enrollment: 116
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Primary outcomes:
measure: Variation of gingival index (Löe Silness) between baseline and 6 months
timeFrame: At 6 months
Secondary outcomes:
measure: bleeding on probing (BOP) score (% of BOP sites)
timeFrame: At Baseline, at 3 months and 6 months
measure: plaque index (O'leary)
timeFrame: At Baseline, at 3 months and 6 months
measure: dysbiosis index
timeFrame: At Baseline, at 3 months and 6 months
measure: level of salivary markers of inflammation -
timeFrame: At Baseline, at 3 months and 6 months
measure: compliance level record
timeFrame: At Baseline, at 3 months and 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Salengro - Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Kevimy AGOSSA
role: PRINCIPAL_INVESTIGATOR
References: