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

Not Applicable

Completed

• Conditions: Root Canal Therapy

• Registration Number: NCT02285595
• Lead Sponsor: Sonendo, Inc.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-03
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-07
• Primary Completion: 2017-06-22
• Study Completion: 2018-12-31
• Results First Submitted: 2022-11-03
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Results First Posted: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5	12 months	The periapical index: A scoring system for radiographic assessment of apical periodontitis. Score of 1: Normal. Score of 2: Small changes in bone structure. Score of 3: Changes in bone structure with some mineral loss (bone loss). Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis). Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis).; Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \<3) and absence of clinical signs and symptoms other than tenderness to percussion.; Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.
Periradicular Diagnosis	12 months	Symptomatic Apical Periodontitis: Inflammation, with clinical symptoms. Asymptomatic Apical Periodontitis: Inflammation with apical radiolucent area, does not produce clinical symptoms. Acute Apical Abscess: Inflammation characterized by rapid onset of clinical symptoms and swelling. Chronic Apical Abscess: Inflammation characterized by gradual onset, little or no discomfort, presence of a sinus tract. Condensing Osteitis: Diffuse radiopaque lesion representing a localized bony reaction to inflammation. Healed is defined by absence of a radiographic indication of apical periodontitis (PAI \<3) and absence of clinical signs and symptoms other than tenderness to percussion.; Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.

Trial Locations

Locations (3)

Shahriar Rassoulian, DMD; 🇺🇸 Aliso Viejo, California, United States

Khang Le, DDS; 🇺🇸 Santa Ana, California, United States

Stacey Woo, DDS; 🇺🇸 Whittier, California, United States