Actively Recruiting
Effect of Probiotics on the Periodontal Status of Orthodontic Patients
Led by University Hospital, Lille · Updated on 2025-12-23
116
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
S
Sunstar, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of Probiotics on the Periodontal Status of Orthodontic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12 to 16 years with social security coverage
- In good general health able to brush and take treatments
- Currently have fixed orthodontic devices
- Consent to participate with parental consent
- Suitable for orthodontic treatment based on oral health
You will not qualify if you...
- Unable to provide informed consent
- Used probiotics, special toothpaste, or antiseptic mouthwash within 1 month before joining
- Allergy or sensitivity to the probiotic or any ingredients in Gum�PerioBalance�user guide
- Received antibiotic therapy or antiseptic mouthwash within 1 month before joining
- Medical conditions requiring prophylactic antibiotics before dental care or immunosuppression
- Conditions or medications affecting the mouth (e.g., pregnancy, diabetes, antiepileptics, tobacco use)
- Oral health requiring urgent care (untreated cavities, active periodontitis, progressive gum recession)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hop Salengro - Chu Lille
Lille, France, 59037
Actively Recruiting
Research Team
K
Kevimy AGOSSA, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here