Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy (SUPREME)

Sonendo

Status: Completed

Conditions: Root Canal Therapy

Treatments: Device: Sonendo GentleWave™ System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02285595

CS-06

Details and patient eligibility

About

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.

Full 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 therapy.

All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 75 years of age
• Indicated for root canal therapy
• First or second molar
• Signed informed consent form

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

69 participants in 1 patient group

Sonendo GentleWave™ System

Other group

Description:

The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

Treatment:

Device: Sonendo GentleWave™ System

Sponsor of this trial

Lead Sponsor

Sonendo