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

The Dental Hospital of Zhejiang University School of Medicine

Status: Not yet enrolling

Conditions: Periodontitis

Treatments: Dietary Supplement: Control; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05275803

DHZhejiangU-2022(025)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Probiotics

Experimental group

Description:

The participants would use probiotics for 30 days

Treatment:

Dietary Supplement: Probiotics

Control

Experimental group

Description:

The participants would use not probiotics

Treatment:

Dietary Supplement: Control