Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients
Primary Purpose
Periodontitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotics
Control
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- age between 35 to 70 years,
- type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%,
- generalized periodontitis (Stage III or IV),
- no less than 15 teeth
Exclusion Criteria:
- smoking, or quit smoking for less than 5 years;
- Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.);
- Received periodontal treatment within 6 months;
- Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months;
- Have taken probiotics within 6 months;
- Prophylactic use of antibiotics is required;
- Pregnant and lactating women;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Probiotics
Control
Arm Description
The participants would use probiotics for 30 days
The participants would use not probiotics
Outcomes
Primary Outcome Measures
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)
Microorganism
measured by 16s rDNA in subgingival plaque and faces
Secondary Outcome Measures
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
Gingival Recession
The distance from the implant margin to the gingival margin was measured with a periodontal probe
Bleeding of Probing
bleeding after periodontal probing
Fasting Blood Glucose
Fasting Blood Glucose in blood
HbA1c
HbA1c in blood
IL-1β、IL-6、TNF-α
IL-1β、IL-6、TNF-α by ELISA in GCF
Full Information
NCT ID
NCT05275803
First Posted
March 2, 2022
Last Updated
June 6, 2023
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05275803
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 8, 2023 (Anticipated)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
The participants would use probiotics for 30 days
Arm Title
Control
Arm Type
Experimental
Arm Description
The participants would use not probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
The participant does not use probiotics after non-surgical periodontal treatment.
Primary Outcome Measure Information:
Title
Probing depth
Description
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)
Time Frame
change from baseline to day 90
Title
Microorganism
Description
measured by 16s rDNA in subgingival plaque and faces
Time Frame
change from baseline to day 90
Secondary Outcome Measure Information:
Title
Gingival index
Description
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
Time Frame
day 0, 30, 90, 150
Title
Gingival Recession
Description
The distance from the implant margin to the gingival margin was measured with a periodontal probe
Time Frame
day 0, 30, 90, 150
Title
Bleeding of Probing
Description
bleeding after periodontal probing
Time Frame
day 0, 30, 90, 150
Title
Fasting Blood Glucose
Description
Fasting Blood Glucose in blood
Time Frame
day 0, 30, 90, 150
Title
HbA1c
Description
HbA1c in blood
Time Frame
day 0, 30, 90, 150
Title
IL-1β、IL-6、TNF-α
Description
IL-1β、IL-6、TNF-α by ELISA in GCF
Time Frame
day 0, 30, 90, 150
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 35 to 70 years,
type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%,
generalized periodontitis (Stage III or IV),
no less than 15 teeth
Exclusion Criteria:
smoking, or quit smoking for less than 5 years;
Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.);
Received periodontal treatment within 6 months;
Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months;
Have taken probiotics within 6 months;
Prophylactic use of antibiotics is required;
Pregnant and lactating women;
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients
We'll reach out to this number within 24 hrs