Probiotics, Periodontitis Clinical Trial
Official title:
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
| Verified date | September 2020 |
| Source | Larena SAS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | September 7, 2020 |
| Est. primary completion date | June 6, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Service d'Odontologie | Lyon | Auvergne-Rhône-Alpes |
| France | CHU Hôtel Dieu de Nantes | Nantes | Pays De La Loire |
| Lead Sponsor | Collaborator |
|---|---|
| PiLeJe |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean level of clinical attachment (CAL) | Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters | up to 3 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Evolution of several oral indices : Pocket depth | pocket depth in millimeters (measured with Florida Probe) | day -14, day 1, day 45, day 90 | |
| Secondary | Evolution of several oral indices : Gingival recession | gingival recession in millimeters (measured with Florida Probe) | day -14, day 1, day 45, day 90 | |
| Secondary | 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 | |
| Secondary | Evolution of halitosis | In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter | day -14, day 1, day 45, day 90 | |
| Secondary | Overall clinical course of periodontitis | according to the dentist, in habitual practise | day -14, day 1, day 45, day 90 | |
| Secondary | Safety (tolerance to treatment) | calculated with adverse events that may be observed during study period (descriptif results) | up to a year | |
| Secondary | Evaluate adherence to treatment | Quick estimation at D+90 | up to a year |