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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

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