A phase I study of KDH-136

Exploration of the safety and efficacy of KDH-136 0.3 mg/mL intracanal administration solution when administered to volunteers who have undergone pulpal necrosis (initial treatment) or pulpectomy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230695

Enrollment

Registered

2024-03-12

Start date

2024-03-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Individuals with pulpal necrosis (initial treatment) or those who have undergone pulpectomy.

Interventions

Single dose of KDH-136 or Standard treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Individuals who are able to provide informed consent. (2) Individuals with pulpal necrosis (initial treatment) or those who have undergone pulpectomy.

Exclusion criteria

Exclusion criteria: (1) Individuals whose target tooth meets one of the following criteria: (a) Unable to prevent microleakage into the root canal (b) Presence of fractures (c) Presence of apical destruction (d) Perforation in the pulp floor or root canal wall

Design outcomes

Primary

Measure	Time frame
Safety, Efficacy	—

Contacts

Public ContactContact for clinical trial information

Kowa Dental Health Co.,Ltd.

msdo@kowa.co.jp+81-3-3279-7836

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026