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

Not Applicable

Completed

• Conditions: Probiotics, Periodontitis

• 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

Study Timeline

• Study First Submitted: 2018-03-16
• Study Start: 2018-05-22
• Study First Submitted QC: 2018-05-30
• Primary Completion: 2018-06-06
• Study First Posted: 2018-06-13
• Status Verified: 2020-09
• Study Completion: 2020-09-07
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24

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

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 Service d'Odontologie; 🇫🇷 Lyon, Auvergne-Rhône-Alpes, France

CHU Hôtel Dieu de Nantes; 🇫🇷 Nantes, Pays De La Loire, France