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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554187
Enrollment
51
Registered
2018-06-13
Start date
2018-05-22
Completion date
2020-09-07
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Probiotics, Periodontitis

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

Interventions

DEVICEUltrasonic 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.

BIOLOGICALAnalyzes of periodontopathogenic bacteria

Collection of plaque, to analyze the bacteria in the pocket

GENETICIL1B test

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

Salivette to chew. To analyse salivary microbiota

DEVICEHalitosis measure

With appropriate device : halimeter

Sponsors

PiLeJe
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Mean level of clinical attachment (CAL)up to 3 monthsClinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters

Secondary

MeasureTime frameDescription
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Tannerella forsythia (Tf) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Treponema denticola (Td) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Prevotella intermedia (Pi) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Fusobacterium nucleatum (Fn) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Evolution of several oral indices : Pocket depthday -14, day 1, day 45, day 90pocket depth in millimeters (measured with Florida Probe)
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteriaday -14, day 1, day 45, day 90measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Evolution of several oral indices : Gingival bleeding on probingday -14, day 1, day 45, day 90gingival bleeding on probing (Florida Probe) in percentage
Evolution of halitosisday -14, day 1, day 45, day 90In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter
Overall clinical course of periodontitisday -14, day 1, day 45, day 90according to the dentist, in habitual practise
Safety (tolerance to treatment)up to a yearcalculated with adverse events that may be observed during study period (descriptif results)
Evaluate adherence to treatmentup to a yearQuick estimation at D+90
Evolution of several oral indices : Gingival recessionday -14, day 1, day 45, day 90gingival recession in millimeters (measured with Florida Probe)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026