MedDataX Logo

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

NCT ID: NCT04634201

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontal Health Gingivitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gingivitis oral microbiota salivary biomarkers probiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Group Type EXPERIMENTAL

Oral probiotics (L. reuteri)

Intervention Type DIETARY_SUPPLEMENT

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

control group

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral probiotics (L. reuteri)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sunstar, Inc.

INDUSTRY

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevimy AGOSSA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hop Salengro - Chu Lille

Lille, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kevimy AGOSSA, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A02179-30

Identifier Type: OTHER

Identifier Source: secondary_id

2019_14

Identifier Type: -

Identifier Source: org_study_id