Root Canal Therapy
Conditions
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.
Interventions
Sponsors
Sonendo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | GentleWave™ Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| PAI Score PAI Score < 3 | 43 Participants |
| PAI Score PAI Score = 3 | 16 Participants |
| PAI Score PAI Score 4 or 5 | 9 Participants |
| Periradicular Diagnosis Acute Apical Abscess | 2 Participants |
| Periradicular Diagnosis Asymptomatic apical periodontitis | 11 Participants |
| Periradicular Diagnosis Chronic Apical Abscess | 3 Participants |
| Periradicular Diagnosis Condensing Osteitis | 1 Participants |
| Periradicular Diagnosis Healing within normal limits | 0 Participants |
| Periradicular Diagnosis Normal periradicular tissue | 12 Participants |
| Periradicular Diagnosis Symptomatic apical periodontitis | 39 Participants |
| Race/Ethnicity, Customized Race of Participants Asian | 8 Participants |
| Race/Ethnicity, Customized Race of Participants Black/ African American | 3 Participants |
| Race/Ethnicity, Customized Race of Participants Caucasian | 20 Participants |
| Race/Ethnicity, Customized Race of Participants Hispanic | 36 Participants |
| Race/Ethnicity, Customized Race of Participants Other | 2 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GentleWave™ Treatment Group | Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 | PAI Score < 3 | 51 Participants |
| GentleWave™ Treatment Group | Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 | PAI Score = 3 | 3 Participants |
| GentleWave™ Treatment Group | Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 | PAI Score 4 or 5 | 0 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.
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GentleWave™ Treatment Group | Periradicular Diagnosis | Normal Apical Tissue | 40 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Acute Apical Abscess | 0 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Condensing Osteitis | 0 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Symptomatic Apical Periodontitis | 0 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Asymptomatic Apical Periodontitis | 0 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Chronic Apical Abscess | 0 Participants |
| GentleWave™ Treatment Group | Periradicular Diagnosis | Healing Within Normal Limits | 14 Participants |