Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients

Study Overview
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Brief Summary
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This study aims to investigate the clinical and microbiological efficacy of Lactobacillus reuteri as an adjunctive therapy to non-surgical periodontal treatment of chronic periodontitis with type 2 diabetes.

Detailed Description
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Periodontitis and diabetes affect the course and outcome of each other. Many studies have shown that for patients with periodontitis, concomitant diabetes can aggravate the destruction of periodontal tissue and accelerate the progression of periodontitis, which is an important risk factor for periodontitis. Affected by diabetes, patients with poor glycemic control have worse periodontal status, and the prognosis of periodontitis treatment is more suspicious. Conversely, periodontitis also affects diabetic status, and periodontitis is associated with dysglycemia, increased insulin resistance, and increased risk of diabetic complications. After periodontal therapy, it is expected to reduce the level of systemic inflammation and ultimately improve glycemic control and overall prognosis of diabetes. However, the treatment of periodontitis with diabetes is still a challenge, and how to improve the prognosis of patients with periodontitis with type 2 diabetes remains to be studied. BioGaia Prodentis is a probiotic chewable tablet containing Lactobacillus reuteri (combination of L. reuteri DSM 17938 and L. reuteri ATCC 5289). Studies have shown that the use of the probiotics has an additional effect on periodontal therapy. However, in the periodontitis patients with type 2 diabetes, whether the use of this probiotic can improve the effect of periodontal therapy, few relevant research have published.

Official Title
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Clinical and Microbiological Efficacy of Lactobacillus Reuteri as an Adjunctive Therapy to Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes: a Randomized Controlled Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 35 to 70 years, type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%, generalized periodontitis (Stage III or IV), no less than 15 teeth Exclusion Criteria: smoking, or quit smoking for less than 5 years; Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.); Received periodontal treatment within 6 months; Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months; Have taken probiotics within 6 months; Prophylactic use of antibiotics is required; Pregnant and lactating women;

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>The participants would use probiotics for 30 days | Dietary Supplement: Probiotics<br>* The participant would receive non-surgical periodontal treatment, after which the participant uses probiotics (BioGaia Prodentis, L. reuteri DSM 17938+L. reuteri ATCC 5289, 0.8g, qn) for another 30 days.<br>|
| Experimental: Control<br>The participants would use not probiotics | Dietary Supplement: Control<br>* The participant does not use probiotics after non-surgical periodontal treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15) | change from baseline to day 90 | 
| Microorganism | measured by 16s rDNA in subgingival plaque and faces | change from baseline to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival index | assessed at four sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, and palatal/lingual) according to the index of Loe and Silness | day 0, 30, 90, 150 | 
| Gingival Recession | The distance from the implant margin to the gingival margin was measured with a periodontal probe | day 0, 30, 90, 150 | 
| Bleeding of Probing | bleeding after periodontal probing | day 0, 30, 90, 150 | 
| Fasting Blood Glucose | Fasting Blood Glucose in blood | day 0, 30, 90, 150 | 
| HbA1c | HbA1c in blood | day 0, 30, 90, 150 | 
| IL-1β、IL-6、TNF-α | IL-1β、IL-6、TNF-α by ELISA in GCF | day 0, 30, 90, 150 |