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

PiLeJe

Status: Completed

Conditions: Probiotics, Periodontitis

Treatments: Genetic: IL1B test; Biological: Salivary Sampling; Biological: Analyzes of periodontopathogenic bacteria; Device: Halitosis measure; Device: Ultrasonic periodontal Debridement, with appropriate device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03554187

2017-A02945-48 (Other Identifier)

Pil-Clin-BuccP-016

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

Lactibiane Buccodental, probiotics

Experimental group

Description:

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

Treatment:

Device: Halitosis measure

Device: Ultrasonic periodontal Debridement, with appropriate device

Genetic: IL1B test

Biological: Salivary Sampling

Biological: Analyzes of periodontopathogenic bacteria

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Halitosis measure

Device: Ultrasonic periodontal Debridement, with appropriate device

Genetic: IL1B test

Biological: Salivary Sampling

Biological: Analyzes of periodontopathogenic bacteria