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

Root Canal Therapy Clinical Trial

— SUPREME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285595
• Other study ID #: CS-06
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2023
• Source: Sonendo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 31, 2018
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Root Canal Therapy

Intervention

Device:
• Sonendo GentleWave™ System

Locations

Country	Name	City	State
United States	Shahriar Rassoulian, DMD	Aliso Viejo	California
United States	Khang Le, DDS	Santa Ana	California
United States	Stacey Woo, DDS	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonendo, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (68)

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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