A Clinical Trial of the Efficacy and Safety of "Igatan F Capsule"in gingivitis patients or mild to moderate chronic periodontitis patients

A Double-blind, Randomized, Multicenter, Placebo-controlled Exploratory Clinical Trial of the Efficacy and Safety of "Igatan F Capsule"in gingivitis patients or mild to moderate chronic periodontitis patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0001366

Enrollment

100

Registered

2015-01-29

Start date

2014-11-03

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 1. Experimental treatment : IGATAN F Capsule, 1Cap*TID*4weeks oral administration->open extension 4weeks( IGATAN F Capsule) 2. Placebo comparator : Placebo Capsule, 1Cap*TID*4weeks oral admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female of at least 18 years of age but not older than 80 years 2. PD(Probing Depth) 4~6mm 3. Gingivitis patients or mild to moderate chronic periodontitis patients

Exclusion criteria

Exclusion criteria: 1. Severe chronic periodontitis patients 2. History of hypersensitivity to IGATAN F Capsule or any related products 3. Any clinical dental treatment(including scaling) in the previous 1 month before day 1 of this study 4. Females are pregnant or lactating 5. Smoker 6. Volunteers who took an Investigational Product in previous 3months before day 1 of this study

Design outcomes

Primary

Measure	Time frame
Gingival Index	—

Secondary

Measure	Time frame
Plaque Index;Clinical Attachment Level;Bleeding On Probing;Probing Depth;Gingival Enlargement;Gingival Recession;100mm VAS (Visual Analogue Scale);Measure Vital Sign	—

Countries

Korea, Republic of

Contacts

Public ContactJong Chung

Kyung Hee University Dental Hospital

chungjh7@gmail.com+82-2-958-9383

Outcome results