NCT03554187

Brief Summary

It aims to demonstrate the superiority of a 6-week supplementation with Lactibiane Buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

January 24, 2022

Status Verified

September 1, 2020

Enrollment Period

15 days

First QC Date

March 16, 2018

Last Update Submit

January 21, 2022

Conditions

Probiotics, Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Mean level of clinical attachment (CAL)

    Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters

    up to 3 months

Secondary Outcomes (13)

  • Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria

    day -14, day 1, day 45, day 90

  • Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria

    day -14, day 1, day 45, day 90

  • Quantitative evolution of Tannerella forsythia (Tf) bacteria

    day -14, day 1, day 45, day 90

  • Quantitative evolution of Treponema denticola (Td) bacteria

    day -14, day 1, day 45, day 90

  • Quantitative evolution of Prevotella intermedia (Pi) bacteria

    day -14, day 1, day 45, day 90

  • +8 more secondary outcomes

Study Arms (2)

Lactibiane Buccodental, probiotics

EXPERIMENTAL

For one tablet : Lactobacillus paracasei LA 802 (109 UFC), Vitamine D3 (1,5 µg), Vitamine C (24 mg) Dosage : 2 tablets daily for 6 weeks tablet to suck after the meal and brushing teeth (one in the morning and one in the evening) Interventions : Ultrasonic periodontal debridement, with appropriate device : D+1 / Analyzes of periodontopathogenic bacteria : D-14, D+1, D+45, D+90 / IL1B test : D-14 / Salivary sampling : D+1, D+45, D+90 / Halitosis measure : D+1, D+45, D+90

Device: Ultrasonic periodontal Debridement, with appropriate deviceBiological: Analyzes of periodontopathogenic bacteriaGenetic: IL1B testBiological: Salivary SamplingDevice: Halitosis measure

Placebo

PLACEBO COMPARATOR

With no metabolic action ; identical in appearance to experimental probiotics Dosage : 2 placebo tablets daily for 6 weeks tablet to suck after the meal and brushing teeth (one in the morning and one in the evening) Intervention(s) : Ultrasonic periodontal debridement, with appropriate device : D+1 / Analyzes of periodontopathogenic bacteria : D-14, D+1, D+45, D+90 / IL1B test : D-14 / Salivary sampling : D+1, D+45, D+90 / Halitosis measure : D+1, D+45, D+90

Device: Ultrasonic periodontal Debridement, with appropriate deviceBiological: Analyzes of periodontopathogenic bacteriaGenetic: IL1B testBiological: Salivary SamplingDevice: Halitosis measure

Interventions

Ultrasonic periodontal Debridement, with appropriate deviceDEVICE

Dental procedure that includes therapeutic interventions such as scaling to remove calculus and all soft deposits, root planing to eliminate subgingival calculus and smooth the tooth surface, and root débridement to eliminate subgingival biofilm and lightly mineralized deposits.

Lactibiane Buccodental, probioticsPlacebo
Analyzes of periodontopathogenic bacteriaBIOLOGICAL

Collection of plaque, to analyze the bacteria in the pocket

Lactibiane Buccodental, probioticsPlacebo
IL1B testGENETIC

susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)

Lactibiane Buccodental, probioticsPlacebo
Salivary SamplingBIOLOGICAL

Salivette to chew. To analyse salivary microbiota

Lactibiane Buccodental, probioticsPlacebo
Halitosis measureDEVICE

With appropriate device : halimeter

Lactibiane Buccodental, probioticsPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with acute oral lesions or necrotizing ulcerative periodontitis;
  • Patient who has taken antibiotics in the last 3 months, or who has received treatment affecting periodontal tissue in the past month, or on immunosuppressive therapy (ciclosporin), antihypertensive (nyfedipine), antiepileptic (phenytoin), under biotherapy, or under treatment of hyposialie;
  • Patient with a medical history or current pathology that, in the opinion of the investigator, is likely to interfere with the results of the study or to expose him / her to additional risk: unbalanced diabetes, rheumatic fever, disease affecting renal or hepatic function, neurological deficiency, immunological disease;
  • Patient smoking more than 10 cigarettes a day;
  • Patient with known allergy to at least one of Lactibiane Buccodental® ingredients;
  • Pregnant or breastfeeding woman or intending to start a pregnancy within 3 months;
  • a woman who is in a state of childbearing not covered by an active method of contraception;
  • Patient with a psychological or linguistic disability to understand and sign informed consent, or to understand and implement the constraints of the study;
  • Patient under legal protection (tutorship, guardianship) or deprived of his rights following the administrative or judicial decision.
  • Patient not affiliated to a social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Service d'Odontologie

Lyon, Auvergne-Rhône-Alpes, 69007, France

Location

CHU Hôtel Dieu de Nantes

Nantes, Pays de la Loire Region, 44000, France

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Samira Ait Abdellah

    PiLeJe

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

June 13, 2018

Study Start

May 22, 2018

Primary Completion

June 6, 2018

Study Completion

September 7, 2020

Last Updated

January 24, 2022

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)