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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04503746

Enrollment

117

Registered

2020-08-07

Start date

2020-07-16

Completion date

2021-12-13

Last updated

2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

periodontitis

Brief summary

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

Interventions

DRUGALH-L1005 600mg/day

ALH-L1005 300mg 2 tablet and placebo 2 tablet

DRUGALH-L1005 1,200mg/day

ALH-L1005 300mg 4 tablet

DRUGPlacebo

Placebo 4 tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 78 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Pocket Depth(PD)	baseline, 12 weeks	Change in Pocket Depth in Subjects

Secondary

Measure	Time frame	Description
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
Change in Gingival recession(GR)	baseline, 12 weeks	Change in Gingival recession in Subjects
Change in Bleeding on probing(BOP) score	baseline, 12 weeks	Change in Bleeding on probing score in Subjects

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026