Clinical trial NCT05275803: Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: The Dental Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Probing depth
timeFrame: change from baseline to day 90
measure: Microorganism
timeFrame: change from baseline to day 90
Secondary outcomes:
measure: Gingival index
timeFrame: day 0, 30, 90, 150
measure: Gingival Recession
timeFrame: day 0, 30, 90, 150
measure: Bleeding of Probing
timeFrame: day 0, 30, 90, 150
measure: Fasting Blood Glucose
timeFrame: day 0, 30, 90, 150
measure: HbA1c
timeFrame: day 0, 30, 90, 150
measure: IL-1β、IL-6、TNF-α
timeFrame: day 0, 30, 90, 150
Other outcomes:
Locations:
Study officials:
References: