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

NCT02285595 | Completed Results

• 1 other identifier: CS-06
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

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.

Conditions

Root Canal Therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5

  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.

  12 months

• Periradicular Diagnosis

  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.

  12 months

Study Arms (1)

Sonendo GentleWave™ System

OTHER

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

Device: Sonendo GentleWave™ System

Interventions

Sonendo GentleWave™ System DEVICE

Sonendo GentleWave™ System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonendo, Inc.: lead

Study Sites (3)

Shahriar Rassoulian, DMD

Aliso Viejo, California, 92656, United States

Location

Khang Le, DDS

Santa Ana, California, 92704, United States

Location

Stacey Woo, DDS

Whittier, California, 90602, United States

Location

Related Publications (68)

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Results Point of Contact

• Title: Director of Clinical Research
• Organization: Sonendo, Inc.

clinical@sonendo.com

9496678036

Study Officials

• Dan Miller

  Sonendo, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 7, 2014
• Study Start: July 1, 2014
• Primary Completion: June 22, 2017
• Study Completion: December 31, 2018
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)