Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
Not Applicable
Completed
- Conditions
- Probiotics, Periodontitis
- Interventions
- Device: Ultrasonic periodontal Debridement, with appropriate deviceBiological: Analyzes of periodontopathogenic bacteriaGenetic: IL1B testBiological: Salivary SamplingDevice: Halitosis measure
- Registration Number
- NCT03554187
- Lead Sponsor
- PiLeJe
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lactibiane Buccodental, probiotics Ultrasonic periodontal Debridement, with appropriate device 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 Lactibiane Buccodental, probiotics Halitosis measure 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 Ultrasonic periodontal Debridement, with appropriate device 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 Placebo Analyzes of periodontopathogenic bacteria 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 Placebo Halitosis measure 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 Lactibiane Buccodental, probiotics Salivary Sampling 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 Salivary Sampling 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 Lactibiane Buccodental, probiotics Analyzes of periodontopathogenic bacteria 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 Lactibiane Buccodental, probiotics IL1B test 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 IL1B test 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
- Primary Outcome Measures
Name Time Method Mean level of clinical attachment (CAL) up to 3 months Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters
- Secondary Outcome Measures
Name Time Method Quantitative evolution of Prevotella intermedia (Pi) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Evolution of several oral indices : Pocket depth day -14, day 1, day 45, day 90 pocket depth in millimeters (measured with Florida Probe)
Evaluate adherence to treatment up to a year Quick estimation at D+90
Quantitative evolution of Tannerella forsythia (Tf) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Evolution of halitosis day -14, day 1, day 45, day 90 In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Evolution of several oral indices : Gingival bleeding on probing day -14, day 1, day 45, day 90 gingival bleeding on probing (Florida Probe) in percentage
Quantitative evolution of Treponema denticola (Td) bacteria day -14, day 1, day 45, day 90 measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Safety (tolerance to treatment) up to a year calculated with adverse events that may be observed during study period (descriptif results)
Evolution of several oral indices : Gingival recession day -14, day 1, day 45, day 90 gingival recession in millimeters (measured with Florida Probe)
Overall clinical course of periodontitis day -14, day 1, day 45, day 90 according to the dentist, in habitual practise
Trial Locations
- Locations (2)
CHU Hôtel Dieu de Nantes
🇫🇷Nantes, Pays De La Loire, France
CHU Service d'Odontologie
🇫🇷Lyon, Auvergne-Rhône-Alpes, France