Root Canal TherapySUPREMENCT02285595

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

A study testing Sonendo GentleWave™ System in people with Root Canal Therapy, run by Sonendo, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Root Canal Therapy
What is being tested?: Sonendo GentleWave™ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 3 sitesUnited States
Study dates: Jul 2014to 31 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Shahriar Rassoulian, DMD
Aliso Viejo, California, 92656
Khang Le, DDS
Santa Ana, California, 92704
Stacey Woo, DDS
Whittier, California, 90602

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Root Canal Therapy
Being tested: Sonendo GentleWave™ System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sonendo GentleWave™ SystemDevice

Study groups in NCT02285595
Study group	Role	What they receive
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. Receives: Device: Sonendo GentleWave™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201431 Dec 2018

First posted7 Nov 2014 (estimated)
Study startJul 2014
Primary completion22 Jun 2017
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (68)Papers the sponsor has linked to this study.
Other trials for Root Canal TherapyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02285595
Sponsor's protocol ID: CS-06
Acronym: SUPREME
Status last verified: Jan 2023
First submitted: 3 Nov 2014
Last updated: 31 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
Individual data sharing: No

Publications

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.
PubMed 12193268
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.
PubMed 12657151
Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.
PubMed 11471648
McGurkin-Smith R, Trope M, Caplan D, Sigurdsson A. Reduction of intracanal bacteria using GT rotary instrumentation, 5.25% NaOCl, EDTA, and Ca(OH)2. J Endod. 2005 May;31(5):359-63. doi: 10.1097/01.don.0000145035.85272.7c.
PubMed 15851929
Hulsmann M, Schade M, Schafers F. A comparative study of root canal preparation with HERO 642 and Quantec SC rotary Ni-Ti instruments. Int Endod J. 2001 Oct;34(7):538-46. doi: 10.1046/j.1365-2591.2001.00431.x.
PubMed 11601772
Vaudt J, Bitter K, Neumann K, Kielbassa AM. Ex vivo study on root canal instrumentation of two rotary nickel-titanium systems in comparison to stainless steel hand instruments. Int Endod J. 2009 Jan;42(1):22-33. doi: 10.1111/j.1365-2591.2008.01489.x.
PubMed 19125977
Wilcox LR, Roskelley C, Sutton T. The relationship of root canal enlargement to finger-spreader induced vertical root fracture. J Endod. 1997 Aug;23(8):533-4. doi: 10.1016/S0099-2399(97)80316-0.
PubMed 9587326
Wu MK, R'oris A, Barkis D, Wesselink PR. Prevalence and extent of long oval canals in the apical third. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jun;89(6):739-43. doi: 10.1067/moe.2000.106344.
PubMed 10846130
Jafarzadeh H, Abbott PV. Ledge formation: review of a great challenge in endodontics. J Endod. 2007 Oct;33(10):1155-62. doi: 10.1016/j.joen.2007.07.015. Epub 2007 Sep 4.
PubMed 17889681
Cohen S., Burns R. C. Pathways of the pulp. 8th ed. St Louis: Mosby, 2002.
Kapalas A, Lambrianidis T. Factors associated with root canal ledging during instrumentation. Endod Dent Traumatol. 2000 Oct;16(5):229-31. doi: 10.1034/j.1600-9657.2000.016005229.x.
PubMed 11202887
Harty FJ, Parkins BJ, Wengraf AM. Success rate in root canal therapy. A retrospective study of conventional cases. Br Dent J. 1970 Jan 20;128(2):65-70. doi: 10.1038/sj.bdj.4802429. No abstract available.
PubMed 5270224
Namazikhah MS, Mokhlis HR, Alasmakh K. Comparison between a hand stainless-steel K file and a rotary NiTi 0.04 taper. J Calif Dent Assoc. 2000 Jun;28(6):421-6.
PubMed 11324127
Greene KJ, Krell KV. Clinical factors associated with ledged canals in maxillary and mandibular molars. Oral Surg Oral Med Oral Pathol. 1990 Oct;70(4):490-7. doi: 10.1016/0030-4220(90)90217-g.
PubMed 2216387
Gutmann J. L., Dumsha T. C., Lovdahl P. E., Hovland E. J. Problem Solving in Endodontics (3rd ed.). St. Louis: Mosby, 1997.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
Active, not recruitingPhase 2
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Cancer of the Cervix, Vulvar Cancer
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis

All Root Canal Therapy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02285595
Acronym / sponsor ID: SUPREME / CS-06
Conditions: Root Canal Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Sonendo, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014 (actual)
Primary completion: 22 Jun 2017 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 7 Nov 2014 (estimated)
Results: Posted 31 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sonendo GentleWave™ System	Other	Device: Sonendo GentleWave™ SystemThe Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sonendo GentleWave™ System	Device	Sonendo GentleWave™ System

Primary outcome

Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 31 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GentleWave™ Treatment Group	69	54

Primary outcome: Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5

Time frame: 12 months. Count of participants. Unit: Participants

Measure	GentleWave™ Treatment Group n = 54
PAI Score < 3	51
PAI Score = 3	3
PAI Score 4 or 5	0

Primary outcome: Periradicular Diagnosis

Time frame: 12 months. Count of participants. Unit: Participants

Measure	GentleWave™ Treatment Group n = 54
Normal Apical Tissue	40
Symptomatic Apical Periodontitis	0
Asymptomatic Apical Periodontitis	0
Acute Apical Abscess	0
Chronic Apical Abscess	0
Condensing Osteitis	0
Healing Within Normal Limits	14

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GentleWave™ Treatment Group	0 of 69 (0%)	0 of 69 (0%)	0 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12193268Peters 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.
Background: PubMed 12657151Peters 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.
Background: PubMed 11471648Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.
Background: PubMed 15851929McGurkin-Smith R, Trope M, Caplan D, Sigurdsson A. Reduction of intracanal bacteria using GT rotary instrumentation, 5.25% NaOCl, EDTA, and Ca(OH)2. J Endod. 2005 May;31(5):359-63. doi: 10.1097/01.don.0000145035.85272.7c.
Background: PubMed 11601772Hulsmann M, Schade M, Schafers F. A comparative study of root canal preparation with HERO 642 and Quantec SC rotary Ni-Ti instruments. Int Endod J. 2001 Oct;34(7):538-46. doi: 10.1046/j.1365-2591.2001.00431.x.
Background: PubMed 19125977Vaudt J, Bitter K, Neumann K, Kielbassa AM. Ex vivo study on root canal instrumentation of two rotary nickel-titanium systems in comparison to stainless steel hand instruments. Int Endod J. 2009 Jan;42(1):22-33. doi: 10.1111/j.1365-2591.2008.01489.x.
Background: PubMed 9587326Wilcox LR, Roskelley C, Sutton T. The relationship of root canal enlargement to finger-spreader induced vertical root fracture. J Endod. 1997 Aug;23(8):533-4. doi: 10.1016/S0099-2399(97)80316-0.
Background: PubMed 10846130Wu MK, R'oris A, Barkis D, Wesselink PR. Prevalence and extent of long oval canals in the apical third. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jun;89(6):739-43. doi: 10.1067/moe.2000.106344.
Background: PubMed 17889681Jafarzadeh H, Abbott PV. Ledge formation: review of a great challenge in endodontics. J Endod. 2007 Oct;33(10):1155-62. doi: 10.1016/j.joen.2007.07.015. Epub 2007 Sep 4.
BackgroundCohen S., Burns R. C. Pathways of the pulp. 8th ed. St Louis: Mosby, 2002.
Background: PubMed 11202887Kapalas A, Lambrianidis T. Factors associated with root canal ledging during instrumentation. Endod Dent Traumatol. 2000 Oct;16(5):229-31. doi: 10.1034/j.1600-9657.2000.016005229.x.
Background: PubMed 5270224Harty FJ, Parkins BJ, Wengraf AM. Success rate in root canal therapy. A retrospective study of conventional cases. Br Dent J. 1970 Jan 20;128(2):65-70. doi: 10.1038/sj.bdj.4802429. No abstract available.
Individual participant dataSharing planned: No

Related trials for Root Canal Therapy

Active, not recruitingPhase 3
Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer
Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma
Active, not recruitingPhase 2
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Cancer of the Cervix, Vulvar Cancer
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
Not yet recruiting
Comparison of Postoperative Pain After Root Canal Treatment Using Hand-Held vs Rotary ProTaper Files: A Randomized Controlled Trial
Symptomatic Irreversible Pulpitis (SIP), Symptomatic Apical Periodontitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dan Miller study director

Sonendo, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sonendo GentleWave™ System in people with Root Canal Therapy, run by Sonendo, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5 (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285595, which also lists 68 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.