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

NCT ID: NCT03554187

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2020-09-07

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

Conditions

Probiotics, Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Ultrasonic periodontal Debridement, with appropriate device

Intervention Type: 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.

Analyzes of periodontopathogenic bacteria

Intervention Type: BIOLOGICAL

Collection of plaque, to analyze the bacteria in the pocket

IL1B test

Intervention Type: GENETIC

susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)

Salivary Sampling

Intervention Type: BIOLOGICAL

Salivette to chew. To analyse salivary microbiota

Halitosis measure

Intervention Type: DEVICE

With appropriate device : halimeter

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

Group Type: PLACEBO_COMPARATOR

Ultrasonic periodontal Debridement, with appropriate device

Intervention Type: 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.

Analyzes of periodontopathogenic bacteria

Intervention Type: BIOLOGICAL

Collection of plaque, to analyze the bacteria in the pocket

IL1B test

Intervention Type: GENETIC

susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)

Salivary Sampling

Intervention Type: BIOLOGICAL

Salivette to chew. To analyse salivary microbiota

Halitosis measure

Intervention Type: DEVICE

With appropriate device : halimeter

Interventions

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.

Intervention Type: DEVICE

Analyzes of periodontopathogenic bacteria

Collection of plaque, to analyze the bacteria in the pocket

Intervention Type: BIOLOGICAL

IL1B test

susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)

Intervention Type: GENETIC

Salivary Sampling

Salivette to chew. To analyse salivary microbiota

Intervention Type: BIOLOGICAL

Halitosis measure

With appropriate device : halimeter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samira Ait Abdellah

Role: STUDY_DIRECTOR

PiLeJe

Locations

CHU Service d'Odontologie

Lyon, Auvergne-Rhône-Alpes, France

CHU Hôtel Dieu de Nantes

Nantes, Pays de la Loire Region, France

Countries

France

Other Identifiers

2017-A02945-48

Identifier Type: OTHER

Identifier Source: secondary_id

Pil-Clin-BuccP-016

Identifier Type: -

Identifier Source: org_study_id