A phase I study of KDH-136

JRCT ID: jRCT2031230695

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Individuals with pulpal necrosis (initial treatment) or those who have undergone pulpectomy.
• Date of first enrollment: 07/03/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Single dose of KDH-136 or Standard treatment

Outcome(s)

• Primary Outcome: Safety, Efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Mitsumasa Nakamura