Study about the plasma device to periodontitis

Not Applicable

• Conditions: periodontitis; D055113

• Registration Number: JPRN-jRCTs032190121
• Lead Sponsor: Chigasaki Otohumi

Brief Summary

In primary endpoint, improvement of Gingival Index (GI) was observed in 4 subjects in Step1, 4 subjects in Step2 and 2 subjects in Step3, which showed no clear relationship between irradiation time and GI improvement. On the other hand, in secondary endpoint, improvement of "Probing Depth (PD)" was observed in 1 subject in Step1, 5 subjects in Step2 and 7 subjects in Step3. It is considered that longer irradiation time leads to greater number of subjects with PD improvement.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Study Completion: 2020-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Written informed consent by subject
2. 20 years old or over
3. Clonic periodontitis
4. Existence of more than 2 pathological change parts in the part left

Exclusion Criteria

1. Expecting, Pregnancing, or milk-feeding to her child
2. Smoker
3. Severe oral disease, or severe general disease
4. Acute pathological change in the mouth
5. Inpossible for follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of gingival index as of the treatment end for about 1 week

Secondary Outcome Measures

Name	Time	Method
gingival index during the period of study<br>bleeding on probing<br>plobing depth<br>attachment level<br>plaque index<br>gingival reduction<br>tooth mobility<br>red complex<br>adverse events or device defects