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

JRCT ID: jRCTs011230038

Registered date:15/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Periodontal disease
• Date of first enrollment: 11/12/2023
• Target sample size: 28
• Study type: Interventional
• Intervention(s): 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 pockets at weeks 0, 2, 4, and 6 using Solfy-F and root planing tip P5.

Outcome(s)

• Primary Outcome: Difference in Gingival Index between both groups after 8 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sugaya Tsutomu