PeriodontitisNCT04129684
A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population
A study testing Probiotics in people with Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 880 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Nov 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Patients diagnosed with periodontitis clinically evident according to International Classification of Periodontal Diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length
- Natural teeth remaining in the mouth≥ 14
Who cannot join
- Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension.
- Patients with aggressive periodontitis.
- Patients who received any periodontal treatment in the past 6 months
- Pregnant or lactating women
- Patients who smoke
- Patients in the acute phase of an infectious disease
Show all 10Show fewer
- Patients taking bisphosphonate mediation
- Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months
- Patients allergic to lactate products
- Patients who are deemed uncooperative
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang University, 310002
Yanmin Wu, Doctor, wym731128@126.com
About this study
Official title: A Randomized Single-blind, Parallel-arm Multi-center Clinical Trial to Evaluate the Effectiveness and Safety of Lactobacillus Reuteri for Treatment of Periodontitis in a Chinese Population
The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients.
Read the detailed description
Periodontitis is a chronic inflammatory disease with a prevalence of 80% in Chinese adults, which is the main cause of tooth loss in adults. Periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. In the last decade, probiotics therapy using Lactobacillus Reuteri has been applied for periodontitis patients in European countries. But no evidence has been provided for its effectiveness in a Chinese population. The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. The influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.
- Conditions
- Periodontitis
- Being tested
- Probiotics
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
subgingival delivery and lozenges
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | SRP+BioGaia Prodentis oil drops and lozenges Receives: Other: Probiotics |
| Control group | Placebo comparator | SRP+subgingival delivery of placebo and placebo lozenges Receives: Other: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pocket Probing Depth(PPD)
Distance from the base of the periodontal pocket to the gingival margin(mm)
Measured: at 3 months
Secondary outcomes (5)
Change from baseline in Pocket Probing Depth
Distance from the base of the periodontal pocket to the gingival margin(mm)
Measured: at baseline, 1, 6 months
Change from baseline in Clinical Attachment Level
Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm)
Measured: at baseline, 1, 3 , 6 months
Change from baseline in Rate of Bleeding on Probing
To evaluate the inflammation and bleeding of gingiva (%)
Measured: at baseline, 1, 3 , 6 months
Number of microorganisms in periodontal pockets
To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU)
Measured: at baseline, 1, 3 and 6 months
Contents of inflammatory cytokines in periodontal pockets and blood
To observe the effectiveness of the probiotic on systemic and local inflammation: TNF-α; IL-1β; IL-6; IL-8; IL-10；INF-γ (Pg/ml)
Measured: at baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Dec 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- West China College of Stomatology, Peking University Third Hospital, Hospital of Stomatology, Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129684
- Sponsor's protocol ID
- 2019-1015
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-blind, Parallel-arm Multi-center Clinical Trial to Evaluate the Effectiveness and Safety of Lactobacillus Reuteri for Treatment of Periodontitis in a Chinese Population
- ClinicalTrials.gov ID
- NCT04129684
- Acronym / sponsor ID
- 2019-1015
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- West China College of Stomatology, Peking University Third Hospital, Hospital of Stomatology, Jilin University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 17 Oct 2019 (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.
The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients.
Detailed description
Periodontitis is a chronic inflammatory disease with a prevalence of 80% in Chinese adults, which is the main cause of tooth loss in adults. Periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. In the last decade, probiotics therapy using Lactobacillus Reuteri has been applied for periodontitis patients in European countries. But no evidence has been provided for its effectiveness in a Chinese population. The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. The influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: ProbioticsSRP+BioGaia Prodentis oil drops and lozenges |
| Control group | Placebo comparator | Other: ProbioticsSRP+subgingival delivery of placebo and placebo lozenges |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age
- Patients diagnosed with periodontitis clinically evident according to International Classification of Periodontal Diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length
- Natural teeth remaining in the mouth≥ 14
Key exclusion criteria (10 listed)
- Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension.
- Patients with aggressive periodontitis.
- Patients who received any periodontal treatment in the past 6 months
- Pregnant or lactating women
- Patients who smoke
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 |
|---|---|---|
| Probioticssubgingival delivery and lozenges | Other | Control group, Test group |
Primary outcome
Change From Baseline in Pocket Probing Depth(PPD)
Time frame: at 3 months
Distance from the base of the periodontal pocket to the gingival margin(mm)
5 secondary outcomes
Change from baseline in Pocket Probing Depth
Time frame: at baseline, 1, 6 months
Change from baseline in Clinical Attachment Level
Time frame: at baseline, 1, 3 , 6 months
Change from baseline in Rate of Bleeding on Probing
Time frame: at baseline, 1, 3 , 6 months
Number of microorganisms in periodontal pockets
Time frame: at baseline, 1, 3 and 6 months
Contents of inflammatory cytokines in periodontal pockets and blood
Time frame: at baseline, 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Periodontitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanmin Wu, Doctor (+86 0571-87783607, wym731128@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pocket Probing Depth(PPD) (time frame: at 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 12 May 2020.