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OpenTrials
Completed

NCT Number: NCT03554187

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Service d'Odontologie, Lyon, Auvergne-Rhône-Alpes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic periodontal Debridement, with appropriate device

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

Biological

Collection of plaque, to analyze the bacteria in the pocket

IL1B test

Genetic

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

Salivary Sampling

Biological

Salivette to chew. To analyse salivary microbiota

Halitosis measure

Device

With appropriate device : halimeter

Primary outcomes

  1. Mean level of clinical attachment (CAL)

    Time frame: up to 3 months

    Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters

Secondary outcomes

  1. Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  2. Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  3. Quantitative evolution of Tannerella forsythia (Tf) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  4. Quantitative evolution of Treponema denticola (Td) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  5. Quantitative evolution of Prevotella intermedia (Pi) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  6. Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria

    Time frame: day -14, day 1, day 45, day 90

    measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria

  7. Evolution of several oral indices : Pocket depth

    Time frame: day -14, day 1, day 45, day 90

    pocket depth in millimeters (measured with Florida Probe)

  8. Evolution of several oral indices : Gingival recession

    Time frame: day -14, day 1, day 45, day 90

    gingival recession in millimeters (measured with Florida Probe)

  9. Evolution of several oral indices : Gingival bleeding on probing

    Time frame: day -14, day 1, day 45, day 90

    gingival bleeding on probing (Florida Probe) in percentage

  10. Evolution of halitosis

    Time frame: day -14, day 1, day 45, day 90

    In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter

  11. Overall clinical course of periodontitis

    Time frame: day -14, day 1, day 45, day 90

    according to the dentist, in habitual practise

  12. Safety (tolerance to treatment)

    Time frame: up to a year

    calculated with adverse events that may be observed during study period (descriptif results)

  13. Evaluate adherence to treatment

    Time frame: up to a year

    Quick estimation at D+90

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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