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

NCT ID: NCT04503746

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2021-12-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 4 tablet

ALH-L1005 600 mg

ALH-L1005 300 mg twice a day

Group Type EXPERIMENTAL

ALH-L1005 600mg/day

Intervention Type DRUG

ALH-L1005 300mg 2 tablet and placebo 2 tablet

ALH-L1005 1,200 mg

ALH-L1005 600 mg twice a day

Group Type EXPERIMENTAL

ALH-L1005 1,200mg/day

Intervention Type DRUG

ALH-L1005 300mg 4 tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALH-L1005 600mg/day

ALH-L1005 300mg 2 tablet and placebo 2 tablet

Intervention Type DRUG

ALH-L1005 1,200mg/day

ALH-L1005 300mg 4 tablet

Intervention Type DRUG

Placebo

Placebo 4 tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AngioLab, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AngioLab, Inc.

Daejeon, Daejeon Gwangyeogsi, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AL102-PDT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.