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Investigation of the Effect of Combined Mouthwash with SP-T Medical Gargle and Scaling on Periodontal Disease

An Open-label, Randomized, Parallel-group, Comparative Study to Investigate the Effect of Combined Mouthwash with SP-T Medical Gargle and Scaling on Periodontal Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs011230038
Enrollment
28
Registered
2023-09-15
Start date
2023-12-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Periodontal disease

Interventions

Combination group: Systema SP-T Medical Gargle is diluted 200 times according to the usage and dosage, rinsed mouth 3 times a day, and continued for 8 weeks. Scaling is performed on all teeth and in p

Sponsors

Saori Tanaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants are patients with periodontal disease who are visiting Hokkaido University Hospital and meet all of the following criteria. 1. Patients aged 18 years old or older. 2. Patients diagnosed with periodontal disease. 3. Patients who have not used mouthwash for more than 6 months. 4. Patients with one or more tooth surfaces with Plaque Index (PlI) of 2 or more and Gingival index (GI) of 2 or higher. 5. Patients who gave consent after sufficient explanation and sufficient understanding before participating in this study.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are excluded from the study. 1. Patients undergoing anticancer drug treatment. 2. Patients receiving immunosuppressants. 3. Patients with a history of hypersensitivity to cetylpyridinium chloride hydrate. 4. Patients who have difficulty rinsing their mouth. 5. Patients with an implantable cardiac pacemaker or implantable cardioverter-defibrillator. 6. Patients with poorly controlled diabetes. 7. Patients receiving antithrombotic therapy. 8. Patients who are pregnant or wish to become pregnant within the observation period. 9. Patients who received antibiotics within 6 months of week 0. 10. Patients who received anti-inflammatory drugs within 4 days of week 0. 11. Patient whose principal/co-investigator judged inappropriate for a study subject.

Design outcomes

Primary

MeasureTime frame
Difference in Gingival Index between both groups after 8 weeks

Secondary

MeasureTime frame
1. Difference between both groups in GI decrease rate before and after treatment 2. Difference between the two groups in the amount of PlI change before and after treatment 3. Difference between the two groups in the amount of change in the ratio of periodontal pathogens to the total number of bacteria in saliva and plaque before and after treatment

Contacts

Public ContactTsutomu Sugaya

Hokkaido University Hospital

crbs2301_sp-tmg@pop.med.hokudai.ac.jp+81-11-706-4266

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026