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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05275803
• Other study ID #: DHZhejiangU-2022(025)
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: June 2023
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 20, 2024
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• 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.
• Control
The participant does not use probiotics after non-surgical periodontal treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Microorganism	measured by 16s rDNA in subgingival plaque and faces	change from baseline to day 90
Secondary	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
Secondary	Gingival Recession	The distance from the implant margin to the gingival margin was measured with a periodontal probe	day 0, 30, 90, 150
Secondary	Bleeding of Probing	bleeding after periodontal probing	day 0, 30, 90, 150
Secondary	Fasting Blood Glucose	Fasting Blood Glucose in blood	day 0, 30, 90, 150
Secondary	HbA1c	HbA1c in blood	day 0, 30, 90, 150
Secondary	IL-1ß?IL-6?TNF-a	IL-1ß?IL-6?TNF-a by ELISA in GCF	day 0, 30, 90, 150