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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
The Dental Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

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

    First Posted
    March 2, 2022
    Last Updated
    June 6, 2023
    Sponsor
    The Dental Hospital of Zhejiang University School of Medicine
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    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

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