Periodontitis
Conditions
Brief 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.
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.
Interventions
OTHERProbiotics
subgingival delivery and lozenges
Sponsors
West China College of Stomatology
Peking University Third Hospital
Hospital of Stomatology, Jilin University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18-65 years of age 2. 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 3. Natural teeth remaining in the mouth≥ 14
Exclusion criteria
1. Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension. 2. Patients with aggressive periodontitis. 3. Patients who received any periodontal treatment in the past 6 months 4. Pregnant or lactating women 5. Patients who smoke 6. Patients in the acute phase of an infectious disease 7. Patients taking bisphosphonate mediation 8. Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months 9. Patients allergic to lactate products 10. Patients who are deemed uncooperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pocket Probing Depth(PPD) | at 3 months | Distance from the base of the periodontal pocket to the gingival margin(mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of microorganisms in periodontal pockets | at baseline, 1, 3 and 6 months | To observe the effectiveness of the probiotic on periodontal microorganisms: P. gingivalis; A. actinomycetemcomitans; T. forsythia; T. denticola; P. intermedia; L. reuteri (CFU) |
| Change from baseline in Pocket Probing Depth | at baseline, 1, 6 months | Distance from the base of the periodontal pocket to the gingival margin(mm) |
| Change from baseline in Clinical Attachment Level | at baseline, 1, 3 , 6 months | Distance from the base of the periodontal pocket to the CEJ or other fixed reference point (mm) |
| Change from baseline in Rate of Bleeding on Probing | at baseline, 1, 3 , 6 months | To evaluate the inflammation and bleeding of gingiva (%) |
| Contents of inflammatory cytokines in periodontal pockets and blood | at baseline, 1, 3 and 6 months | 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) |
Countries
China
Contacts
Primary ContactYanmin Wu, Doctor
Outcome results
None listed