NIPH Clinical Trials Search

LAC-PERIO-GLUCO Study

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	type 2 diabetes mellitus, periodontitis
Date of first enrollment	09/04/2026
Target sample size	23
Countries of recruitment
Study type	Interventional
Intervention(s)	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 subject meets the inclusion criteria and does not violate any exclusion criteria. Subjects deemed eligible will engage in self-care using probiotics toothpaste Gel and probiotics mouthwash for 16 weeks. At the start of self-care and at the first and second dental and oral surgery treatments, the oral and maxillofacial surgery department will check the self-care status and provide oral hygiene guidance. Starting four weeks after the start of self-care, the oral and maxillofacial surgery department will perform scaling (removal of tartar and plaque that has accumulated on the surface of the teeth and at the gum line) every six weeks. Self-care will continue even after dental and oral surgery treatment begins. There will be no changes to the diabetes treatment from two months before the start of the study until its completion.

Outcome(s)

Primary Outcome

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 Outcome

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) and glucose metabolism indicators (fasting blood glucose, HbA1c, glycoalbumin, insulin resistance index, CGM index) before and after dental and oral surgery periodontitis treatment at weeks 4 and 16, stratified by dental treatment receipt rate 8) 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 the entire period at week 0 and week 16 9) 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 the entire period from week 0 to week 16 10) 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 entire period at week 0 and week 16, stratified by self-care implementation rate. 11) 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 entire period at week 0 and week 16, stratified by dental treatment receipt rate

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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