Clinical trial NCT02285595: Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Official title: A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Therapy
Lead sponsor: Sonendo, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 therapy.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5
timeFrame: 12 months
measure: Periradicular Diagnosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Shahriar Rassoulian, DMD
state: California
city: Santa Ana
country: United States
facility: Khang Le, DDS
state: California
city: Whittier
country: United States
facility: Stacey Woo, DDS
state: California
Study officials:
affiliation: Sonendo, Inc.
name: Dan Miller
role: STUDY_DIRECTOR
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