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

The Dental Hospital of Zhejiang University School of Medicine48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontitis

Interventions

ProbioticsDIETARY_SUPPLEMENT

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.

ControlDIETARY_SUPPLEMENT

The participant does not use probiotics after non-surgical periodontal treatment.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age between 35 to 70 years, 2. type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%, 3. generalized periodontitis (Stage III or IV), 4. no less than 15 teeth Exclusion Criteria: 1. smoking, or quit smoking for less than 5 years; 2. Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.); 3. Received periodontal treatment within 6 months; 4. Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months; 5. Have taken probiotics within 6 months; 6. Prophylactic use of antibiotics is required; 7. Pregnant and lactating women;

Outcomes

Primary Outcomes

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)

Time frame: change from baseline to day 90

Microorganism

measured by 16s rDNA in subgingival plaque and faces

Time frame: change from baseline to day 90

Secondary Outcomes

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