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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Placebo; Drug: ALH-L1005 600mg/day; Drug: ALH-L1005 1,200mg/day

• Registration Number: NCT04503746
• Lead Sponsor: AngioLab, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo twice a day
ALH-L1005 600 mg	ALH-L1005 600mg/day	ALH-L1005 300 mg twice a day
ALH-L1005 1,200 mg	ALH-L1005 1,200mg/day	ALH-L1005 600 mg twice a day

Primary Outcome Measures

Name	Time	Method
Change in Pocket Depth(PD)	baseline, 12 weeks	Change in Pocket Depth in Subjects

Secondary Outcome Measures

Name	Time	Method
Change in Bleeding on probing(BOP) score	baseline, 12 weeks	Change in Bleeding on probing score in Subjects
Change in Gingival recession(GR)	baseline, 12 weeks	Change in Gingival recession in Subjects
Change in Pocket Depth(PD)	baseline, 4 weeks, 8 weeks	Change in Pocket Depth in Subjects
Change in Clinical Attachment Level(CAL)	baseline, 4 weeks, 8 weeks, 12 weeks	Change in Clinical Attachment Level in Subjects

Trial Locations

Locations (1)

AngioLab, Inc.; 🇰🇷 Daejeon, Daejeon Gwangyeogsi, Korea, Republic of