Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis

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

Study Overview

• Status: Completed
• Conditions: Probiotics, Periodontitis
• Intervention / Treatment: Device: Ultrasonic periodontal Debridement, with appropriate device; Biological: Analyzes of periodontopathogenic bacteria; Genetic: IL1B test; Biological: Salivary Sampling; Device: Halitosis measure

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69007
      • CHU Service d'Odontologie
  • Pays De La Loire
    • Nantes, Pays De La Loire, France, 44000
      • CHU Hôtel Dieu de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criterion:

• Age ≥ 18;
• Patient with moderate to severe chronic periodontitis (mean attachment loss ≥ 3 mm), generalized (more than 30% of sites with loss of attachment), with presence of at least one of three bacterial species the red complex (either Pg, Tf or Td), which, according to the practitioner, may be the result of mechanical treatment (ultrasonic debridement);
• Patient able and willing to participate in the research by complying with the procedures of the protocol especially concerning the consumption of the product under study and having served it by signing a dated informed consent form;

Criteria of non-inclusion:

• 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 participating in another clinical trial, or at the time of exclusion from another clinical trial;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lactibiane Buccodental, probiotics; 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 device; 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.; Biological: Analyzes of periodontopathogenic bacteria; Collection of plaque, to analyze the bacteria in the pocket; Genetic: IL1B test; susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive); Biological: Salivary Sampling; Salivette to chew. To analyse salivary microbiota; Device: Halitosis measure; With appropriate device : halimeter
PLACEBO_COMPARATOR: Placebo; 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 device; 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.; Biological: Analyzes of periodontopathogenic bacteria; Collection of plaque, to analyze the bacteria in the pocket; Genetic: IL1B test; susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive); Biological: Salivary Sampling; Salivette to chew. To analyse salivary microbiota; Device: Halitosis measure; With appropriate device : halimeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean level of clinical attachment (CAL)	Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Quantitative evolution of Tannerella forsythia (Tf) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Quantitative evolution of Treponema denticola (Td) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Quantitative evolution of Prevotella intermedia (Pi) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria	measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria	day -14, day 1, day 45, day 90
Evolution of several oral indices : Pocket depth	pocket depth in millimeters (measured with Florida Probe)	day -14, day 1, day 45, day 90
Evolution of several oral indices : Gingival recession	gingival recession in millimeters (measured with Florida Probe)	day -14, day 1, day 45, day 90
Evolution of several oral indices : Gingival bleeding on probing	gingival bleeding on probing (Florida Probe) in percentage	day -14, day 1, day 45, day 90
Evolution of halitosis	In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter	day -14, day 1, day 45, day 90
Overall clinical course of periodontitis	according to the dentist, in habitual practise	day -14, day 1, day 45, day 90
Safety (tolerance to treatment)	calculated with adverse events that may be observed during study period (descriptif results)	up to a year
Evaluate adherence to treatment	Quick estimation at D+90	up to a year

Collaborators and Investigators

• Sponsor: PiLeJe
• Investigators: Study Director: Samira Ait Abdellah, PiLeJe

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2018
• Primary Completion (ACTUAL): June 6, 2018
• Study Completion (ACTUAL): September 7, 2020

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): June 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: Pil-Clin-BuccP-016; 2017-A02945-48 (OTHER: Number ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No