A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis

Official Title
-----------------
A Multi-center, Randomized, Double-Blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of 12-week Treatment of ALH-L1005 600 mg or 1200 mg in Patients With Chronic Periodontitis

Conditions
-----------------
Chronic Periodontitis

Intervention / Treatment
-----------------
* Drug: ALH-L1005 600mg/day
* Drug: ALH-L1005 1,200mg/day
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women ages 18 and over, under 79 years of age Patients diagnosed with chronic periodontitis Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm Patients who are voluntarily participated in clinical trial Exclusion Criteria: History of antibiotic therapy within the 1 month prior to study Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study Subjects who are pregnant/ lactating Smokers Patients who take Anticoagulants or Antiplatelet Agents With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo twice a day | Drug: Placebo<br>* Placebo 4 tablet<br>|
| Experimental: ALH-L1005 600 mg<br>ALH-L1005 300 mg twice a day | Drug: ALH-L1005 600mg/day<br>* ALH-L1005 300mg 2 tablet and placebo 2 tablet<br>|
| Experimental: ALH-L1005 1,200 mg<br>ALH-L1005 600 mg twice a day | Drug: ALH-L1005 1,200mg/day<br>* ALH-L1005 300mg 4 tablet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pocket Depth(PD) | Change in Pocket Depth in Subjects | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pocket Depth(PD) | Change in Pocket Depth in Subjects | baseline, 4 weeks, 8 weeks | 
| Change in Clinical Attachment Level(CAL) | Change in Clinical Attachment Level in Subjects | baseline, 4 weeks, 8 weeks, 12 weeks | 
| Change in Gingival recession(GR) | Change in Gingival recession in Subjects | baseline, 12 weeks | 
| Change in Bleeding on probing(BOP) score | Change in Bleeding on probing score in Subjects | baseline, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
periodontitis