Probiotics, Periodontitis
Conditions
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
Interventions
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.
Collection of plaque, to analyze the bacteria in the pocket
susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)
Salivette to chew. To analyse salivary microbiota
With appropriate device : halimeter
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean level of clinical attachment (CAL) | up to 3 months | Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Quantitative evolution of Tannerella forsythia (Tf) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Quantitative evolution of Treponema denticola (Td) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Quantitative evolution of Prevotella intermedia (Pi) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Evolution of several oral indices : Pocket depth | day -14, day 1, day 45, day 90 | pocket depth in millimeters (measured with Florida Probe) |
| Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria | day -14, day 1, day 45, day 90 | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| Evolution of several oral indices : Gingival bleeding on probing | day -14, day 1, day 45, day 90 | gingival bleeding on probing (Florida Probe) in percentage |
| Evolution of halitosis | day -14, day 1, day 45, day 90 | In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter |
| Overall clinical course of periodontitis | day -14, day 1, day 45, day 90 | according to the dentist, in habitual practise |
| Safety (tolerance to treatment) | up to a year | calculated with adverse events that may be observed during study period (descriptif results) |
| Evaluate adherence to treatment | up to a year | Quick estimation at D+90 |
| Evolution of several oral indices : Gingival recession | day -14, day 1, day 45, day 90 | gingival recession in millimeters (measured with Florida Probe) |
Countries
France