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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonendo GentleWave™ System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Miller | Sonendo, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahriar Rassoulian, DMD | Aliso Viejo | California | 92656 | United States | ||
| Khang Le, DDS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12193268 | Background | Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x. | |
| 12657151 | Background | Peters OA, Peters CI, Schonenberger K, Barbakow F. ProTaper rotary root canal preparation: effects of canal anatomy on final shape analysed by micro CT. Int Endod J. 2003 Feb;36(2):86-92. doi: 10.1046/j.1365-2591.2003.00626.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GentleWave™ Treatment Group | Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GentleWave™ Treatment Group | Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GentleWave™ Treatment Group | Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Sonendo, Inc. | 9496678036 | clinical@sonendo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2015 | Dec 22, 2022 | Prot_SAP_000.pdf |
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| Santa Ana |
| California |
| 92704 |
| United States |
| Stacey Woo, DDS | Whittier | California | 90602 | United States |
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| 11357217 | Background | World Medical Association.. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2. No abstract available. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| PAI Score | Orstavik D., Kerekes K, Ericksen H. M. The periapical index: A scoring system for radiographic assessment of apical periodontitis. Dent Traumatol J 1986;2: 20-34. 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) | One subject had withdrawn from the study prior to data analysis. Healed is defined by absence of a radiographic indication of apical peridontitis (PAI <3) and absence of clinical signs and symptoms other than tenderness to percussion. | Count of Participants | Participants |
|
| Periradicular Diagnosis | AAE Consensus Conference Recommended Diagnostic Terminology, JOE 35(12):1634, 2009. 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. | One patient withdrew prior to data analysis | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
|
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| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
Not provided
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| Acute Apical Abscess |
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| Chronic Apical Abscess |
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| Condensing Osteitis |
|
| Healing Within Normal Limits |
|