Probiotics, PeriodontitisNCT03554187
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
A study testing Ultrasonic periodontal Debridement, with appropriate device, Analyzes of periodontopathogenic bacteria and IL1B test in people with Probiotics, Periodontitis, run by PiLeJe at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Probiotics, Periodontitis
- What is being tested?
- Ultrasonic periodontal Debridement, with appropriate device, Analyzes of periodontopathogenic bacteria and IL1B test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 22 May 2018to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Service d'Odontologie
Lyon, Auvergne-Rhône-Alpes, 69007
CHU Hôtel Dieu de Nantes
Nantes, Pays de la Loire Region, 44000
About this study
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
- Conditions
- Probiotics, Periodontitis
- Being tested
- Ultrasonic periodontal Debridement, with appropriate device, Analyzes of periodontopathogenic bacteria, IL1B test, Salivary Sampling, Halitosis measure
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic periodontal Debridement, with appropriate deviceDevice
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.
Analyzes of periodontopathogenic bacteriaBiological
Collection of plaque, to analyze the bacteria in the pocket
IL1B testGenetic
susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)
Salivary SamplingBiological
Salivette to chew. To analyse salivary microbiota
Halitosis measureDevice
With appropriate device : halimeter
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Ultrasonic periodontal Debridement, with appropriate device; Biological: Analyzes of periodontopathogenic bacteria; Genetic: IL1B test; Biological: Salivary Sampling; Device: Halitosis measure |
| 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 Receives: Device: Ultrasonic periodontal Debridement, with appropriate device; Biological: Analyzes of periodontopathogenic bacteria; Genetic: IL1B test; Biological: Salivary Sampling; Device: Halitosis measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean level of clinical attachment (CAL)
Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters
Measured: up to 3 months
Secondary outcomes (13)
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Measured: day -14, day 1, day 45, day 90
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria
measured from a non-invasive sample in the parontal pocket. Result expressed in number of bacteria
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day -14, day 1, day 45, day 90
Evolution of several oral indices : Pocket depth
pocket depth in millimeters (measured with Florida Probe)
Measured: day -14, day 1, day 45, day 90
Evolution of several oral indices : Gingival recession
gingival recession in millimeters (measured with Florida Probe)
Measured: 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
Measured: day -14, day 1, day 45, day 90
Evolution of halitosis
In expired breath : Volatil Sulfur Compounds (in ppm) measure with Halimeter
Measured: day -14, day 1, day 45, day 90
Overall clinical course of periodontitis
according to the dentist, in habitual practise
Measured: 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)
Measured: up to a year
Evaluate adherence to treatment
Quick estimation at D+90
Measured: up to a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start22 May 2018
- Primary completion6 Jun 2018
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Probiotics, PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samira Ait Abdellah, Study director, PiLeJe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554187
- Sponsor's protocol ID
- Pil-Clin-BuccP-016
- Other IDs
- 2017-A02945-48
- Status last verified
- Sep 2020
- First submitted
- 16 Mar 2018
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT03554187
- Acronym / sponsor ID
- Pil-Clin-BuccP-016
- Conditions
- Probiotics, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 22 May 2018 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactibiane Buccodental, probiotics | Experimental | Device: Ultrasonic periodontal Debridement, with appropriate device, Biological: Analyzes of periodontopathogenic bacteria, Genetic: IL1B test, Biological: Salivary Sampling, Device: Halitosis measureFor 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 | Device: Ultrasonic periodontal Debridement, with appropriate device, Biological: Analyzes of periodontopathogenic bacteria, Genetic: IL1B test, Biological: Salivary Sampling, Device: Halitosis measureWith 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic periodontal Debridement, with appropriate deviceDental 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. | Device | Lactibiane Buccodental, probiotics, Placebo |
| Analyzes of periodontopathogenic bacteriaCollection of plaque, to analyze the bacteria in the pocket | Biological | Lactibiane Buccodental, probiotics, Placebo |
| IL1B testsusceptibility to periodontal disease (scratch swab onto the tongue) (no invasive) | Genetic | Lactibiane Buccodental, probiotics, Placebo |
| Salivary SamplingSalivette to chew. To analyse salivary microbiota | Biological | Lactibiane Buccodental, probiotics, Placebo |
| Halitosis measureWith appropriate device : halimeter | Device | Lactibiane Buccodental, probiotics, Placebo |
Primary outcome
Mean level of clinical attachment (CAL)
Time frame: up to 3 months
Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters
13 secondary outcomes
Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria
Time frame: day -14, day 1, day 45, day 90
Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria
Time frame: day -14, day 1, day 45, day 90
Quantitative evolution of Tannerella forsythia (Tf) bacteria
Time frame: day -14, day 1, day 45, day 90
Quantitative evolution of Treponema denticola (Td) bacteria
Time frame: day -14, day 1, day 45, day 90
Quantitative evolution of Prevotella intermedia (Pi) bacteria
Time frame: day -14, day 1, day 45, day 90
Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria
Time frame: day -14, day 1, day 45, day 90
Evolution of several oral indices : Pocket depth
Time frame: day -14, day 1, day 45, day 90
Evolution of several oral indices : Gingival recession
Time frame: day -14, day 1, day 45, day 90
Evolution of several oral indices : Gingival bleeding on probing
Time frame: day -14, day 1, day 45, day 90
Evolution of halitosis
Time frame: day -14, day 1, day 45, day 90
Overall clinical course of periodontitis
Time frame: day -14, day 1, day 45, day 90
Safety (tolerance to treatment)
Time frame: up to a year
Evaluate adherence to treatment
Time frame: up to a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samira Ait Abdellah study director
PiLeJe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic periodontal Debridement, with appropriate device, Analyzes of periodontopathogenic bacteria and IL1B test in people with Probiotics, Periodontitis, run by PiLeJe at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean level of clinical attachment (CAL) (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.