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

AngioLab

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: ALH-L1005 1,200mg/day; Drug: Placebo; Drug: ALH-L1005 600mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT04503746

AL102-PDT

Details and patient eligibility

About

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

Enrollment: 117 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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117 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo twice a day

Treatment:

Drug: Placebo

ALH-L1005 600 mg

Experimental group

Description:

ALH-L1005 300 mg twice a day

Treatment:

Drug: ALH-L1005 600mg/day

ALH-L1005 1,200 mg

Experimental group

Description:

ALH-L1005 600 mg twice a day

Treatment:

Drug: ALH-L1005 1,200mg/day