Dentin Caries
Conditions
Keywords
Wisdom Tooth, Dentin Caries
Brief summary
The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries
Detailed description
The design is a single site, double-blind, randomized study. Phase 2 study to evaluate physiologic dentin regeneration and safety of KH001. The total duration of the study will be approximately 5 to 9 weeks.
Interventions
DRUGKH001
topical application of KH001
DRUGPlacebo
topical application of Water for Injection
Sponsors
HysensBio Co., Ltd
Byoung-Moo Seo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Is between 19 and 35 of age by the time of the screening * Has signed written informed consent in the study * Subject who either have no pain in the affected tooth, or can endure pain until the day of tooth extraction
Exclusion criteria
* Is allergic to the active ingredient or other ingredients used in the investigational product * Have participated in another clinical study within 30 days from screening visit and have a history of administration/application of investigational product/device * Is judged by the investigator as ineligible for participation for other reasens
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of physiological dentin formation | Week 5 | Histological analysis after wisdom tooth extraction by histological analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 9 weeks | The adverse event name, onset date, resolution date, and other relevant details will be recorded until end of visit. |
| Oral soft/hard tissue examination | Up to 9 weeks | Evaluation of oral condition by referring to maximum probing depth. |
Countries
South Korea
Outcome results
None listed