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

Not Applicable

Not yet recruiting

• Conditions: Periodontitis
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Control

• Registration Number: NCT05275803
• Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-11
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Study Start: 2023-06-08
• Primary Completion: 2023-06-20
• Study Completion: 2024-05-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotics	The participants would use probiotics for 30 days
Control	Control	The participants would use not probiotics

Primary Outcome Measures

Name	Time	Method
Probing depth	change from baseline to day 90	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)
Microorganism	change from baseline to day 90	measured by 16s rDNA in subgingival plaque and faces

Secondary Outcome Measures

Name	Time	Method
Bleeding of Probing	day 0, 30, 90, 150	bleeding after periodontal probing
Fasting Blood Glucose	day 0, 30, 90, 150	Fasting Blood Glucose in blood
HbA1c	day 0, 30, 90, 150	HbA1c in blood
Gingival index	day 0, 30, 90, 150	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
Gingival Recession	day 0, 30, 90, 150	The distance from the implant margin to the gingival margin was measured with a periodontal probe
IL-1β、IL-6、TNF-α	day 0, 30, 90, 150	IL-1β、IL-6、TNF-α by ELISA in GCF