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Completed

NCT Number: NCT04503746

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

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

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Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AngioLab, Inc.

Daejeon, Daejeon Gwangyeogsi, 34015, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALH-L1005 600mg/day

Drug

ALH-L1005 300mg 2 tablet and placebo 2 tablet

ALH-L1005 1,200mg/day

Drug

ALH-L1005 300mg 4 tablet

Placebo

Drug

Placebo 4 tablet

Primary outcomes

  1. Change in Pocket Depth(PD)

    Time frame: baseline, 12 weeks

    Change in Pocket Depth in Subjects

Secondary outcomes

  1. Change in Pocket Depth(PD)

    Time frame: baseline, 4 weeks, 8 weeks

    Change in Pocket Depth in Subjects

  2. Change in Clinical Attachment Level(CAL)

    Time frame: baseline, 4 weeks, 8 weeks, 12 weeks

    Change in Clinical Attachment Level in Subjects

  3. Change in Gingival recession(GR)

    Time frame: baseline, 12 weeks

    Change in Gingival recession in Subjects

  4. Change in Bleeding on probing(BOP) score

    Time frame: baseline, 12 weeks

    Change in Bleeding on probing score in Subjects

Sponsors and collaborators

Lead sponsor

AngioLab, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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