Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A02945-48 | Other Identifier | Number ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactibiane Buccodental, probiotics | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean level of clinical attachment (CAL) | Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria | day -14, day 1, day 45, day 90 |
| Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria |
Not provided
Inclusion criterion:
Criteria of non-inclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samira Ait Abdellah | PiLeJe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Service d'Odontologie | Lyon | Auvergne-Rhône-Alpes | 69007 | France | ||
| CHU Hôtel Dieu de Nantes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria |
| day -14, day 1, day 45, day 90 |
| Quantitative evolution of Tannerella forsythia (Tf) bacteria | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria | day -14, day 1, day 45, day 90 |
| Quantitative evolution of Treponema denticola (Td) bacteria | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria | day -14, day 1, day 45, day 90 |
| Quantitative evolution of Prevotella intermedia (Pi) bacteria | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria | day -14, day 1, day 45, day 90 |
| Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria | measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria | day -14, day 1, day 45, day 90 |
| Evolution of several oral indices : Pocket depth | pocket depth in millimeters (measured with Florida Probe) | day -14, day 1, day 45, day 90 |
| Evolution of several oral indices : Gingival recession | gingival recession in millimeters (measured with Florida Probe) | day -14, day 1, day 45, day 90 |
| Evolution of several oral indices : Gingival bleeding on probing | gingival bleeding on probing (Florida Probe) in percentage | day -14, day 1, day 45, day 90 |
| Evolution of halitosis | In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter | day -14, day 1, day 45, day 90 |
| Overall clinical course of periodontitis | according to the dentist, in habitual practise | day -14, day 1, day 45, day 90 |
| Safety (tolerance to treatment) | calculated with adverse events that may be observed during study period (descriptif results) | up to a year |
| Evaluate adherence to treatment | Quick estimation at D+90 | up to a year |
| Nantes |
| Pays de la Loire Region |
| 44000 |
| France |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided