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NCT04503746 Clinical Trial

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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04503746
Other study ID # AL102-PDT
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 16, 2020
Est. completion date December 13, 2021

Study information
Verified date August 2022
Source AngioLab, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date December 13, 2021
Est. primary completion date December 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 78 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ALH-L1005 600mg/day
ALH-L1005 300mg 2 tablet and placebo 2 tablet
• ALH-L1005 1,200mg/day
ALH-L1005 300mg 4 tablet
• Placebo
Placebo 4 tablet

Locations
Country Name City State
Korea, Republic of AngioLab, Inc. Daejeon Daejeon Gwangyeogsi

Sponsors (1)
Lead Sponsor Collaborator
AngioLab, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Pocket Depth(PD) Change in Pocket Depth in Subjects baseline, 12 weeks
Secondary Change in Pocket Depth(PD) Change in Pocket Depth in Subjects baseline, 4 weeks, 8 weeks
Secondary Change in Clinical Attachment Level(CAL) Change in Clinical Attachment Level in Subjects baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Change in Gingival recession(GR) Change in Gingival recession in Subjects baseline, 12 weeks
Secondary Change in Bleeding on probing(BOP) score Change in Bleeding on probing score in Subjects baseline, 12 weeks
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