Status:
COMPLETED
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Lead Sponsor:
Sonendo, Inc.
Conditions:
Root Canal Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
Detailed Description
A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal ther...
Eligibility Criteria
Inclusion
- 18 to 75 years of age
- Indicated for root canal therapy
- First or second molar
- Signed informed consent form
Exclusion
- Poor oral hygiene
- Class II or III mobility
- Open or incompletely formed root apices
- Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)
- Previous pulpectomy or root canal therapy
- Note: Additional exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02285595
Start Date
July 1 2014
End Date
December 31 2018
Last Update
January 31 2023
Active Locations (3)
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1
Shahriar Rassoulian, DMD
Aliso Viejo, California, United States, 92656
2
Khang Le, DDS
Santa Ana, California, United States, 92704
3
Stacey Woo, DDS
Whittier, California, United States, 90602