Investigational Procedure for Type 2 Diabetes and Gum Disease

No longer recruiting at 5 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sanofi Pasteur, a Sanofi Company

Must not be taking: Anticoagulants, Antibiotics, Immunosuppressants, others

Disqualifiers: Bleeding disorder, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the connection between type 2 diabetes and gum disease. Researchers aim to understand how various biological markers, such as proteins in the blood, link these two conditions. The study divides participants into groups based on diabetes status and gum health to examine their interaction. Individuals with type 2 diabetes, gum disease, or both, for at least six months, may qualify for this study. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of these conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants, systemic antibiotics, immunomodulators, or long-term corticosteroids, you may need to stop them before joining the study.

What prior data suggests that this investigational procedure is safe?

Research has shown that cleaning the teeth and gums, known as periodontal treatment, is safe for people with type 2 diabetes and gum disease. A study with adults who have type 2 diabetes found that this treatment reduced body inflammation after 12 months, indicating that the procedure is generally well-tolerated. The study reported no major side effects, which is reassuring for those considering joining a trial. While the study aims to explore the interaction between diabetes and gum disease, earlier research suggests the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to understanding the link between type 2 diabetes and gum disease. Unlike traditional treatments that address either diabetes or periodontal disease separately, this investigational procedure examines how these conditions might be connected, potentially leading to more comprehensive care strategies. By collecting and analyzing samples like blood, saliva, and plaque, researchers aim to uncover new insights that could lead to innovative, integrated treatment options for people affected by both conditions.

What evidence suggests that this investigational procedure is effective for type 2 diabetes and gum disease?

This trial will investigate an investigational procedure for participants with type 2 diabetes and gum disease. Research has shown that treating gum disease in people with type 2 diabetes can lead to better health. One study found that dental treatment reduced signs of inflammation in people with diabetes over a year. Another study showed that this treatment helped control blood sugar levels for at least three months. Non-surgical treatments, such as deep cleaning of the teeth and gums, have effectively managed gum disease. Overall, these treatments improve both dental health and diabetes management. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This study is for men and women aged 30-70 with a BMI under 40. It's open to those without diabetes or pre-diabetes, as well as those who've had type 2 diabetes for at least six months. Participants can also have varying stages of gum disease but must meet specific criteria based on their hemoglobin A1c levels.

Inclusion Criteria

Body mass index < 40 kg/m2

I am between 30 and 70 years old.

I either have healthy gums, mild/moderate gum disease, or severe gum disease diagnosed recently.

Exclusion Criteria

I have not received any blood products or immune globulins in the last 3 months.

I have had cancer or leukemia in the past year.

I have had a deep dental cleaning in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

1 visit (in-person)

Specimen Collection

Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) are collected from participants

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after specimen collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Procedure

Trial Overview

The trial is investigating how certain biomarkers in the blood and gums interact in people with type 2 diabetes and periodontitis (gum disease). Participants will be divided into nine groups based on their diabetes control and gum disease severity to study these interactions.

How Is the Trial Designed?

Group I: Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes Mellitus Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group II: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group III: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group IV: Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes Mellitus Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group V: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group VI: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group VII: Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes Mellitus Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group VIII: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Group IX: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8 Experimental Treatment 1 Intervention

Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials

429

Recruited

6,140,000+

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Published Research Related to This Trial

In a study of 83 adults with type 2 diabetes and 75 controls, periodontal treatment significantly reduced systemic inflammation markers after 12 months, particularly in those with diabetes and periodontitis.

Individuals with diabetes and periodontitis had higher systemic inflammation levels compared to non-diabetic controls, but after treatment, they experienced a greater reduction in inflammation, highlighting the importance of periodontal care in managing diabetes-related inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of periodontitis reduces systemic inflammation in type 2 diabetes. Preshaw, PM., Taylor, JJ., Jaedicke, KM., et al.[2022]

Non-surgical periodontal treatment (SRP) significantly improved clinical parameters in both individuals with type 2 diabetes (DM2) and systemically healthy (SH) individuals with chronic periodontitis, indicating its efficacy in managing periodontal health.

Despite initial differences in subgingival microbiota composition, both groups showed a reduction in harmful bacteria after SRP, with the DM2 group experiencing a notable decrease in periodontal pathogens, suggesting that SRP can effectively alter the microbial environment in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbiological changes after periodontal therapy in diabetic patients with inadequate metabolic control. Silva-Boghossian, CM., Orrico, SR., Gonçalves, D., et al.[2019]

Non-surgical periodontal treatment significantly improved periodontal health in patients with type 2 diabetes, as evidenced by reductions in plaque index, gingival index, probing depth, and clinical attachment loss over 12 months.

While both mild and moderate-to-severe periodontal disease groups showed improvements in periodontal parameters, there was no significant change in metabolic parameters like glycated hemoglobin or inflammatory markers after treatment, indicating that while periodontal health improved, it did not translate to better metabolic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of periodontal status and effectiveness of non-surgical treatment in patients with type 2 diabetes mellitus in Taiwan for a 1-year period. Auyeung, L., Wang, PW., Lin, RT., et al.[2022]

In a study of over 60,000 patients with type 2 diabetes, those who used metformin had a significantly lower incidence of gingival and periodontal diseases (GPD) compared to non-users, with a hazard ratio of 0.627, indicating a protective effect.

The risk of GPD decreased in a dose-response manner, showing that longer use (around 2 years) and higher cumulative doses of metformin (over 670 grams) were associated with greater reductions in GPD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metformin and risk of gingival/periodontal diseases in diabetes patients: A retrospective cohort study. Tseng, CH.[2022]

Both type-2 diabetic and nondiabetic patients with moderate to severe periodontitis showed significant improvements in clinical parameters such as plaque index, gingival index, and probing depth after nonsurgical periodontal therapy over a 3-month period.

While both groups improved in clinical measures, the diabetic group had a statistically significant reduction in glycated hemoglobin levels, indicating better metabolic control, while lipid profile changes were not significant in the diabetic group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of clinical and metabolic changes after non surgical periodontal treatment of type 2 diabetes mellitus patients: A clinico biochemical study. Kudva, P., Tabasum, ST., Garg, N.[2021]

Nonsurgical periodontal treatment significantly improved the oral microbiota composition in both periodontitis patients with and without type 2 diabetes mellitus (T2DM), leading to increased microbial diversity and a reduction in harmful bacteria.

The treatment not only enhanced periodontal health but also improved glycemic control in patients with T2DM, suggesting that periodontal therapy could be a beneficial adjunct in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral microbiota in periodontitis patients with and without type 2 diabetes mellitus and their shifts after the nonsurgical periodontal therapy. Wang, L., Gao, Z., Zhao, Z., et al.[2023]

In a study of 15 type 2 diabetes patients with periodontitis, periodontal initial therapy significantly reduced levels of glycosylated hemoglobin (HbA1C) and circulating tumor necrosis factor-alpha (TNF-alpha) after 4-6 weeks, indicating improved diabetes control.

The therapy effectively lowered inflammation and blood sugar levels, suggesting that treating periodontal disease may have beneficial effects on managing type 2 diabetes, although it did not significantly change body mass index (BMI) or cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of periodontal initial therapy on circulating TNF-alpha and HbA1C in type 2 diabetes patients with periodontitis]. Yang, PS., Wang, Y., Qi, XM., et al.[2022]

In a study involving 91 diabetic patients with periodontitis, periodontal treatment significantly improved oral health but did not lead to meaningful changes in glycaemic control as measured by HbA1C and fructosamine levels.

The treatment was found to be safe and resulted in a significant improvement in oral health-related quality of life, although there was no overall improvement in general quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of periodontal treatment on diabetic patients: The DIAPERIO randomized controlled trial. Vergnes, JN., Canceill, T., Vinel, A., et al.[2022]

In a study of 88 patients with chronic periodontitis and uncontrolled type 2 diabetes, immediate non-surgical periodontal therapy led to significantly better clinical and metabolic outcomes after 3 months compared to delayed therapy.

The treatment, which included scaling, root planning, and a combination of antibiotics (amoxicillin and metronidazole), not only improved periodontal health but also positively impacted metabolic markers like glycated hemoglobin (HbA1c).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of non-surgical periodontal therapy on glycemic control in diabetic patients: A randomized controlled trial. El-Makaky, Y., Shalaby, HK.[2022]

Citations

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