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

NCT ID: NCT05275803

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2024-05-20

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotics

The participants would use probiotics for 30 days

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_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.

Control

The participants would use not probiotics

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotics

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.

Intervention Type: DIETARY_SUPPLEMENT

Control

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

Intervention Type: DIETARY_SUPPLEMENT

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;

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Peihui Ding

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DHZhejiangU-2022(025)

Identifier Type: -

Identifier Source: org_study_id