Effect of Probiotics on the Periodontal Status of Orthodontic Patients (POP)

Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances

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

Study Overview

• Status: Recruiting
• Conditions: Gingivitis; Periodontal Health
• Intervention / Treatment: Dietary supplement: Oral probiotics (L. reuteri); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevimy AGOSSA, MD; Phone Number: 0320445962; Email: kevimy.agossa@univ-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Salengro - Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group	Dietary supplement: Oral probiotics (L. reuteri); administration of probiotic containing tablets twice daily after tooth brushing for 3 months
SHAM_COMPARATOR: control group	Dietary supplement: Placebo; administration of a placebo twice daily after tooth brushing for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation of gingival index (Löe Silness) between baseline and 6 months	At 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Sunstar, Inc.
• Investigators: Principal Investigator: Kevimy AGOSSA, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2022
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; Gingivitis; oral microbiota; salivary biomarkers
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 2019_14; 2020-A02179-30 (OTHER: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No