Effect of Probiotics on the Periodontal Status of Orthodontic Patients (NCT04634201) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Probiotics on the Periodontal Status of Orthodontic Patients
Stopped: sponsor decision
France3 participantsStarted 2022-03-23
Plain-language 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
Who can participate
Age range
12 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation of gingival index (Löe Silness) between baseline and 6 months