PeriodontitisNCT05275803
Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients
A study testing Probiotics in people with Periodontitis, run by The Dental Hospital of Zhejiang University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
About this study
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
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.
Read the 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
- Being tested
- Probiotics, Control
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary 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.
ControlDietary supplement
The participant does not use probiotics after non-surgical periodontal treatment.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | The participants would use probiotics for 30 days Receives: Dietary Supplement: Probiotics |
| Control | Experimental | The participants would use not probiotics Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: change from baseline to day 90
Microorganism
measured by 16s rDNA in subgingival plaque and faces
Measured: change from baseline to day 90
Secondary outcomes (6)
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
Measured: day 0, 30, 90, 150
Gingival Recession
The distance from the implant margin to the gingival margin was measured with a periodontal probe
Measured: day 0, 30, 90, 150
Bleeding of Probing
bleeding after periodontal probing
Measured: day 0, 30, 90, 150
Fasting Blood Glucose
Fasting Blood Glucose in blood
Measured: day 0, 30, 90, 150
HbA1c
HbA1c in blood
Measured: day 0, 30, 90, 150
IL-1β、IL-6、TNF-α
IL-1β、IL-6、TNF-α by ELISA in GCF
Measured: day 0, 30, 90, 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start8 Jun 2023 (estimated)
- Primary completion20 Jun 2023 (estimated)
- Study completion20 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275803
- Sponsor's protocol ID
- DHZhejiangU-2022(025)
- Status last verified
- Jun 2023
- First submitted
- 2 Mar 2022
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05275803
- Acronym / sponsor ID
- DHZhejiangU-2022(025)
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 8 Jun 2023 (estimated)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 20 May 2024 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsThe participants would use probiotics for 30 days |
| Control | Experimental | Dietary Supplement: ControlThe participants would use not probiotics |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsThe 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. | Dietary supplement | Probiotics |
| ControlThe participant does not use probiotics after non-surgical periodontal treatment. | Dietary supplement | Control |
Primary outcome
Probing depth
Time frame: 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
Time frame: change from baseline to day 90
measured by 16s rDNA in subgingival plaque and faces
6 secondary outcomes
Gingival index
Time frame: day 0, 30, 90, 150
Gingival Recession
Time frame: day 0, 30, 90, 150
Bleeding of Probing
Time frame: day 0, 30, 90, 150
Fasting Blood Glucose
Time frame: day 0, 30, 90, 150
HbA1c
Time frame: day 0, 30, 90, 150
IL-1β、IL-6、TNF-α
Time frame: day 0, 30, 90, 150
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Periodontitis, run by The Dental Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: change from baseline to day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.