Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Not Applicable

Recruiting

• Conditions: Periodontal Health; Gingivitis
• Interventions: Dietary Supplement: Oral probiotics (L. reuteri); Dietary Supplement: Placebo

• Registration Number: NCT04634201
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-18
• Study Start: 2022-03-23
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Oral probiotics (L. reuteri)	-
control group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Variation of gingival index (Löe Silness) between baseline and 6 months	At 6 months

Secondary Outcome Measures

Name	Time	Method
plaque index (O'leary)	At Baseline, at 3 months and 6 months
level of salivary markers of inflammation -	At Baseline, at 3 months and 6 months
bleeding on probing (BOP) score (% of BOP sites)	At Baseline, at 3 months and 6 months
dysbiosis index	At Baseline, at 3 months and 6 months	Shannon-weaver, alpha rarefaction, beta diversity
compliance level record	At Baseline, at 3 months and 6 months

Trial Locations

Locations (1)

Hop Salengro - Chu Lille; 🇫🇷 Lille, France