Purpose: Through nationally assigned projects about the development of high value-added food for the prevention and treatment of periodontal disease, the extraction of Ligularia stenocephala and wheat sprout (ELW) was introduced. ELW showed its efficacy in vivo and in vitro. The aim of this clinical study is to determine the efficacy of ELW in prevention and treatment of periodontitis in humans.

Backgrounds:
- Matrix metalloproteinase (MMP) is induced by inflammatory cytokines and plays a significant role in development of periodontal disease. Since its significant role in periodontal disease, various substances have been developed for inhibition of MMPs. Tetracycline is one of the MMP inhibiting antibiotics, but it has limitations in general application to patients.
- There is an over-the-counter medicine for periodontal disease based on unsaponifiable material from saponification of corn. It consists of beta-sitosterol, squalene, carotene tocopherol and more. Beta-sitosterol which is pro-vitamin D is known to be effective for periodontal health, however, there is no sufficient evidence for support. There is controversial that this kind of medicines are just nutrition without any specific efficacy for periodontal health.
- Also, there is another type of over-the counter medicine for periodontal disease, which consists of vitamin E, C and inhibiting materials for inflammation and bleeding. This kind of medicines has limitation that it cannot deal with fundamental causes of periodontal disease. Thus, taking this kind of medicine cannot accomplish periodontal health.
- Most of medicines for periodontal disease are composed of ascorbic acid, herbal extracts or antibiotics like doxycycline and chlorhexidine. They mainly work as anti-inflammatory and anti-microbial. Only a few studies evaluated specific efficacy to periodontal disease

 Supportive Care

- Test group: Extraction of Ligularia stenocephala and wheat sprout (ELW) 300mg capsule (extracted with 50% alcohol), 1 capsule for daily oral intake for 4 weeks
_ Control group: Placebo dextrin 300mg capsule with same shape and color with ELW. 1 capsule for daily oral intake for 4 weeks
Subjects were randomly assigned to test and control group. There was no intervention to subjects without daily oral intake of assigned capsule.

Arm Label

Target Number of Participant

Arm Type

Arm Description

- Test group: Extraction of Ligularia stenocephala and wheat sprout (ELW) 300mg capsule (extracted with 50% alcohol), 1 capsule for daily oral intake for 4 weeks

Arm Label

Target Number of Participant

Arm Type

Arm Description

_ Control group: Placebo dextrin 300mg capsule with same shape and color with ELW. 1 capsule for daily oral intake for 4 weeks

Gender

Age

Description

1) Male or female whose age is in 18~80 years old
2) Subjects who have more than 18 natural teeth
3) Subjects who have sites with probing depth more than 3mm
4) Subjects who have at least two teeth with bleeding on probing in a sextant
5) Subjects who are diagnosed as gingivitis or chronic generalized incipient to moderate periodontitis

1) Subjects who did not sign on a written consent form.
2) Subjects who are pregnant or lactating
3) Subjects who have uncontrolled systemic diseases like severe hypertension and diabetes
4) Subjects who did not enroll in other clinical studies in recent 3 months
5) Subjects who are intaking antiplatelet or anticoagulant or who have hemorrhagic disease
6) Subjects who had cancer in past 5 years.
7) Subjects who had antibiotic therapy in a recent month
8) Subjects who had periodontal treatment in recent six month, except scaling
9) Subjects who have pathologic appearance (e.g: leukoplakia, lichen planus)
10) Subjects who are decide not to be appropriate in clinician's decision
11) Subjects who had allergy in ingredients for medication
12) Subjects who smokes more than 10 cigarrettes / day

Bleeding on probing, Clinical attachment loss

Every visits.

Levels of biomarkers in saliva and gingival crevicular fluid

First visit and last visit

Blood test data

First visit and last visit