Trial Outcomes & Findings for Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy (NCT NCT02285595)

Last Updated: 2023-01-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

12 months

Results posted on

2023-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	69
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	14
Overall Study Withdrawal by Subject	1

Baseline Characteristics

One subject had withdrawn from the study prior to data analysis.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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GentleWave™ Treatment Group n=69 Participants Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Age, Categorical <=18 years	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=69 Participants
Age, Categorical >=65 years	1 Participants n=69 Participants
Sex: Female, Male Female	37 Participants n=69 Participants
Sex: Female, Male Male	32 Participants n=69 Participants
Race/Ethnicity, Customized Race of Participants · Asian	8 Participants n=69 Participants
Race/Ethnicity, Customized Race of Participants · Black/ African American	3 Participants n=69 Participants
Race/Ethnicity, Customized Race of Participants · Caucasian	20 Participants n=69 Participants
Race/Ethnicity, Customized Race of Participants · Hispanic	36 Participants n=69 Participants
Race/Ethnicity, Customized Race of Participants · Other	2 Participants n=69 Participants
PAI Score PAI Score < 3	43 Participants n=68 Participants • 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.
PAI Score PAI Score = 3	16 Participants n=68 Participants • 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.
PAI Score PAI Score 4 or 5	9 Participants n=68 Participants • 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.
Periradicular Diagnosis Normal periradicular tissue	12 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Healing within normal limits	0 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Symptomatic apical periodontitis	39 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Asymptomatic apical periodontitis	11 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Acute Apical Abscess	2 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Chronic Apical Abscess	3 Participants n=68 Participants • One patient withdrew prior to data analysis
Periradicular Diagnosis Condensing Osteitis	1 Participants n=68 Participants • One patient withdrew prior to data analysis

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	GentleWave™ Treatment Group n=54 Participants Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 PAI Score = 3	3 Participants
Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 PAI Score 4 or 5	0 Participants
Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 PAI Score < 3	51 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GentleWave™ Treatment Group n=54 Participants Participants were given Sonendo GentleWave System Root Canal Treatment to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
Periradicular Diagnosis Normal Apical Tissue	40 Participants
Periradicular Diagnosis Symptomatic Apical Periodontitis	0 Participants
Periradicular Diagnosis Asymptomatic Apical Periodontitis	0 Participants
Periradicular Diagnosis Acute Apical Abscess	0 Participants
Periradicular Diagnosis Chronic Apical Abscess	0 Participants
Periradicular Diagnosis Condensing Osteitis	0 Participants
Periradicular Diagnosis Healing Within Normal Limits	14 Participants

Adverse Events

GentleWave™ Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

Sonendo, Inc.

Phone: 9496678036

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place