Clinical trial NCT03554187: Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
Official title: Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotics, Periodontitis
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean level of clinical attachment (CAL)
timeFrame: up to 3 months
Secondary outcomes:
measure: Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Quantitative evolution of Tannerella forsythia (Tf) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Quantitative evolution of Treponema denticola (Td) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Quantitative evolution of Prevotella intermedia (Pi) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria
timeFrame: day -14, day 1, day 45, day 90
measure: Evolution of several oral indices : Pocket depth
timeFrame: day -14, day 1, day 45, day 90
measure: Evolution of several oral indices : Gingival recession
timeFrame: day -14, day 1, day 45, day 90
measure: Evolution of several oral indices : Gingival bleeding on probing
timeFrame: day -14, day 1, day 45, day 90
measure: Evolution of halitosis
timeFrame: day -14, day 1, day 45, day 90
measure: Overall clinical course of periodontitis
timeFrame: day -14, day 1, day 45, day 90
measure: Safety (tolerance to treatment)
timeFrame: up to a year
measure: Evaluate adherence to treatment
timeFrame: up to a year
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU Service d'Odontologie
state: Auvergne-Rhône-Alpes
city: Nantes
country: France
facility: CHU Hôtel Dieu de Nantes
state: Pays De La Loire
Study officials:
affiliation: PiLeJe
name: Samira Ait Abdellah
role: STUDY_DIRECTOR
References: