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

Primary Purpose

Probiotics, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasonic periodontal Debridement, with appropriate device
Analyzes of periodontopathogenic bacteria
IL1B test
Salivary Sampling
Halitosis measure
Sponsored by
PiLeJe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Probiotics, Periodontitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Service d'Odontologie
  • CHU Hôtel Dieu de Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactibiane Buccodental, probiotics

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean level of clinical attachment (CAL)
Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2018
Last Updated
January 21, 2022
Sponsor
PiLeJe
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1. Study Identification

Unique Protocol Identification Number
NCT03554187
Brief Title
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
Official Title
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
September 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PiLeJe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Probiotics, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactibiane Buccodental, probiotics
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Ultrasonic periodontal Debridement, with appropriate device
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Analyzes of periodontopathogenic bacteria
Intervention Description
Collection of plaque, to analyze the bacteria in the pocket
Intervention Type
Genetic
Intervention Name(s)
IL1B test
Intervention Description
susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)
Intervention Type
Biological
Intervention Name(s)
Salivary Sampling
Intervention Description
Salivette to chew. To analyse salivary microbiota
Intervention Type
Device
Intervention Name(s)
Halitosis measure
Intervention Description
With appropriate device : halimeter
Primary Outcome Measure Information:
Title
Mean level of clinical attachment (CAL)
Description
Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Quantitative evolution of Tannerella forsythia (Tf) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Quantitative evolution of Treponema denticola (Td) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Quantitative evolution of Prevotella intermedia (Pi) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria
Description
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Time Frame
day -14, day 1, day 45, day 90
Title
Evolution of several oral indices : Pocket depth
Description
pocket depth in millimeters (measured with Florida Probe)
Time Frame
day -14, day 1, day 45, day 90
Title
Evolution of several oral indices : Gingival recession
Description
gingival recession in millimeters (measured with Florida Probe)
Time Frame
day -14, day 1, day 45, day 90
Title
Evolution of several oral indices : Gingival bleeding on probing
Description
gingival bleeding on probing (Florida Probe) in percentage
Time Frame
day -14, day 1, day 45, day 90
Title
Evolution of halitosis
Description
In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter
Time Frame
day -14, day 1, day 45, day 90
Title
Overall clinical course of periodontitis
Description
according to the dentist, in habitual practise
Time Frame
day -14, day 1, day 45, day 90
Title
Safety (tolerance to treatment)
Description
calculated with adverse events that may be observed during study period (descriptif results)
Time Frame
up to a year
Title
Evaluate adherence to treatment
Description
Quick estimation at D+90
Time Frame
up to a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samira Ait Abdellah
Organizational Affiliation
PiLeJe
Official's Role
Study Director
Facility Information:
Facility Name
CHU Service d'Odontologie
City
Lyon
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
69007
Country
France
Facility Name
CHU Hôtel Dieu de Nantes
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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