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Effect of Probiotics on the Periodontal Status of Orthodontic Patients (POP)

Primary Purpose

Periodontal Health, Gingivitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral probiotics (L. reuteri)
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Health focused on measuring Gingivitis, oral microbiota, salivary biomarkers, probiotics

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hop Salengro - Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

control group

Arm Description

Outcomes

Primary Outcome Measures

Variation of gingival index (Löe Silness) between baseline and 6 months

Secondary Outcome Measures

bleeding on probing (BOP) score (% of BOP sites)
plaque index (O'leary)
dysbiosis index
Shannon-weaver, alpha rarefaction, beta diversity
level of salivary markers of inflammation -
compliance level record

Full Information

First Posted
November 16, 2020
Last Updated
February 7, 2023
Sponsor
University Hospital, Lille
Collaborators
Sunstar, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04634201
Brief Title
Effect of Probiotics on the Periodontal Status of Orthodontic Patients
Acronym
POP
Official Title
Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Sunstar, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Health, Gingivitis
Keywords
Gingivitis, oral microbiota, salivary biomarkers, probiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Sham Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral probiotics (L. reuteri)
Intervention Description
administration of probiotic containing tablets twice daily after tooth brushing for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
administration of a placebo twice daily after tooth brushing for 3 months
Primary Outcome Measure Information:
Title
Variation of gingival index (Löe Silness) between baseline and 6 months
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
bleeding on probing (BOP) score (% of BOP sites)
Time Frame
At Baseline, at 3 months and 6 months
Title
plaque index (O'leary)
Time Frame
At Baseline, at 3 months and 6 months
Title
dysbiosis index
Description
Shannon-weaver, alpha rarefaction, beta diversity
Time Frame
At Baseline, at 3 months and 6 months
Title
level of salivary markers of inflammation -
Time Frame
At Baseline, at 3 months and 6 months
Title
compliance level record
Time Frame
At Baseline, at 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevimy AGOSSA, MD
Phone
0320445962
Email
kevimy.agossa@univ-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevimy AGOSSA
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Salengro - Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Effect of Probiotics on the Periodontal Status of Orthodontic Patients

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