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

A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control

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.

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.

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.