Effect of Probiotics on the Periodontal Status of Orthodontic Patients

NCT04634201 | Recruiting

• 2 other identifiers: 2019_142020-A02179-30
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Health; Gingivitis

Keywords

Gingivitis; oral microbiota; salivary biomarkers; probiotics

Outcome Measures

Primary Outcomes (1)

• Variation of gingival index (Löe Silness) between baseline and 6 months

  At 6 months

Secondary Outcomes (5)

• 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

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

Dietary Supplement: Oral probiotics (L. reuteri)

control group

SHAM COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

administration of a placebo twice daily after tooth brushing for 3 months

control group

Oral probiotics (L. reuteri) DIETARY_SUPPLEMENT

administration of probiotic containing tablets twice daily after tooth brushing for 3 months

Experimental group

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• inability to obtain informed consent
• allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)
• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

Hop Salengro - Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kevimy AGOSSA

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevimy AGOSSA, MD

CONTACT

0320445962; kevimy.agossa@univ-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 18, 2020
• Study Start: March 23, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)