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

Phase 2CompletedNCT04503746

AngioLab, Inc.117 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

117

Conditions

Chronic Periodontitis

Interventions

ALH-L1005 600mg/dayDRUG

ALH-L1005 300mg 2 tablet and placebo 2 tablet

ALH-L1005 1,200mg/dayDRUG

ALH-L1005 300mg 4 tablet

PlaceboDRUG

Placebo 4 tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (1)

AngioLab, Inc.

Daejeon, Daejeon Gwangyeogsi, South Korea

Outcomes

Primary Outcomes

Change in Pocket Depth(PD)

Change in Pocket Depth in Subjects

Time frame: baseline, 12 weeks

Secondary Outcomes

Change in Pocket Depth(PD)

Change in Pocket Depth in Subjects

Time frame: baseline, 4 weeks, 8 weeks

Change in Clinical Attachment Level(CAL)

Change in Clinical Attachment Level in Subjects

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks

Change in Gingival recession(GR)

Change in Gingival recession in Subjects

Time frame: baseline, 12 weeks

Change in Bleeding on probing(BOP) score

Change in Bleeding on probing score in Subjects

Time frame: baseline, 12 weeks

Data from ClinicalTrials.gov

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