Probiotics to reduce gum inflammation in teens with fixed braces
Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
It tests whether taking an oral probiotic (Lactobacillus reuteri) along with regular brushing can reduce gum inflammation and change the oral bacteria in 12–16-year-olds who wear fixed orthodontic appliances.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 12 Years to 16 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT04634201 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled trial comparing daily oral Lactobacillus reuteri supplements versus placebo given in addition to routine toothbrushing in adolescents aged 12–16 with fixed orthodontic devices. Participants will be randomly assigned to probiotic or placebo groups and neither participants nor study staff will know assignments. Clinical measures of gingival inflammation will be combined with salivary biomarker testing and microbiological analysis of dental plaque to track changes over time. The trial excludes recent users of antibiotics, probiotics, or antiseptic mouthwashes and those with medical conditions affecting the oral cavity.
Who should consider this trial
Good fit: Adolescents aged 12–16 in good general health who wear fixed orthodontic appliances, have parental consent and French social security coverage, and have not used antibiotics, probiotics, or antiseptic mouthwash in the past month are ideal candidates.
Not a fit: Patients who are immunosuppressed, have diabetes, are pregnant, use tobacco, have recent antibiotic or antiseptic mouthwash exposure, require priority dental care, or are allergic to the probiotic components may not receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this could reduce gum inflammation and lower periodontal pathogen levels in teens with braces, making daily oral hygiene easier and possibly reducing the need for additional dental care.
How similar studies have performed: In vitro and in vivo studies and a recent systematic review have shown positive effects of probiotics on periodontal pathogens and as an adjunct to brushing in periodontitis, but evidence for prevention of gum disease in orthodontic teenagers is limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lille
- Hop Salengro - Chu Lille — Lille, France (Recruiting)
Study contacts
- Principal investigator: Kevimy AGOSSA — University Hospital, Lille
- Study coordinator: Kevimy AGOSSA, MD
- Email: kevimy.agossa@univ-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.