RecruitingNot ApplicableNCT04634201

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

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


Sponsor

University Hospital, Lille

Enrollment

116 participants

Start Date

Mar 23, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 12 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking a probiotic supplement can improve gum (periodontal) health in young patients who wear fixed orthodontic appliances (braces). When braces are placed, they make it harder to clean teeth properly, which allows bacteria to build up and can cause gum inflammation. Probiotics are beneficial bacteria that may help restore a healthier balance of bacteria in the mouth and reduce gum disease. Adolescents aged 12 to 16 who are starting orthodontic treatment will be randomly assigned to receive either a specific probiotic (Gum PerioBalance) or a control, and their gum health will be monitored over time. This study will help determine whether adding probiotics to an orthodontic patient's routine can meaningfully improve oral health outcomes. You may be eligible if: - You are between 12 and 16 years old - You are in good general health - You have fixed orthodontic appliances (braces) - You and your parents have given consent to participate - You are covered by social security You may NOT be eligible if: - You have used another probiotic or antiseptic mouthwash in the past month - You have had antibiotic therapy in the past month - You have conditions or medications that could affect your mouth (e.g., diabetes, pregnancy, epilepsy medications, tobacco use) - You have untreated cavities, active periodontitis, or other urgent oral health needs - You are allergic to any ingredients in the Gum PerioBalance probiotic - You are immunosuppressed or require prophylactic antibiotics before dental care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOral probiotics (L. reuteri)

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

DIETARY_SUPPLEMENTPlacebo

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


Locations(1)

Hop Salengro - Chu Lille

Lille, France

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NCT04634201


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