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LAC-PERIO-GLUCO Study

A Pilot Study on the Effects of Toothpaste Gel and Mouthwash Containing Lactobacillus rhamnosus components Combined with Periodontal Treatment on Periodontitis and Glucose Metabolism - LAC-PERIO-GLUCO Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021260001
Enrollment
23
Registered
2026-04-09
Start date
2026-04-09
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus, periodontitis type 2 diabetes mellitus, periodontitis

Interventions

The principal investigator or co-investigator will obtain written consent to participate in the study and, based on the results of the screening test, will determine eligibility by confirming that the

Sponsors

Waki Hironori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women over 18 years old 2) Patients daignosed with type 2 diabetes 3) Patients with HbA1c of 7.0-10.0% 4) Patients who answered that they had oral symptoms in the Japanese version of the CDC/AAP questionnaire 5) Patients with a probing pocket depth of 4mm or more

Exclusion criteria

Exclusion criteria: 1) Systemic diseases that increase the risk of periodontal disease (e.g., leukemia, AIDS) 2) Smoking 3) Receiving immunosuppressants 4) Receiving steroids 5) Acute illness 6) Pregnancy or breastfeeding 7) Change in diabetes treatment within 10 weeks prior to the start of the study 8) Receiving antibiotics within 12 weeks prior to the start of the study 9) Dental treatment for periodontal disease within 12 weeks prior to the start of the study 10) Daily use of mouthwash 11) Fewer than 11 remaining teeth 12) Periapical lesion 13) Orthodontic treatment

Design outcomes

Primary

MeasureTime frame
Changes in periodontitis indicators (probing pocket depth, gingival index) and glucose metabolism indicators (fasting blood glucose, glycoalbumin, TIR on CGM) before and after the self-care period at week 0 and week 4

Secondary

MeasureTime frame
1) Changes in periodontitis indicators (high-sensitivity CRP, ADCHECK, OHRQL) and glucose metabolism indicators (HbA1c, insulin resistance index, CGM indicators) before and after the self-care period at week 0 and week 4 2) The relationship between changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK) and changes in glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM index) during the self-care period from week 0 to week 4 3) Changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK, OHRQL) and glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM index) before and after the self-care period at week 0 and week 4, stratified by self-care implementation rate 4) Changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK, OHRQL) and glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM indices) before and after dental and oral surgery periodontitis treatment at weeks 4 and 16 5) The relationship between changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK) and changes in glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM indices) during dental and oral surgery periodontitis treatment from week 4 to week 16 6) Changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK, OHRQL) and glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM index) before and after dental oral surgery periodontitis treatment at weeks 4 and 16, stratified by self-care implementation rate. 7) Changes in periodontitis indicators (probing pocket depth, gingival index, high-sensitivity CRP, ADCHECK, OHRQL) a

Contacts

Public ContactHana Akanuma

Akita University Hospital

hanabusa.2121@gmail.com+81-18-884-6769

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026