Symptomatic Irreversible PulpitisNCT04552132

Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

A study testing Multisonic vs Sonic activation of irrigants in people with Symptomatic Irreversible Pulpitis and Apical Periodontitis, run by St. Louis University at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Symptomatic Irreversible Pulpitis, Apical Periodontitis
What is being tested?: Multisonic vs Sonic activation of irrigants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2020to 16 Mar 2022
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.

Who cannot join

Minors
Pregnant women
Prisoners
Persons unable to adequately provide informed consent
Non-restorable teeth
Patients unable to sit in the dental chair for 3 hours

Show all 12Show fewer

Patients with compromised cardiac health requiring less than .08mg epinephrine
Patients with a pacemaker
Patients where Ibuprofen and Acetaminophen are contraindicated
Patients unable to swallow pills
Patients with pain originating somewhere other than the tooth in question
Patients having taken analgesics within previous 6 hours

Trial locations and contacts

1 site in 1 country.

United States1 site

Saint Louis University Center for Advanced Dental Education
St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator

Patients with painful molars will be randomly assigned to 2 different groups: GentleWave and EndoActivator. The root canals will be completed using identical protocols except in the mode of delivery and activation of irrigation (using either the GentleWave or EndoActivator). Postoperative pain and pain pill consumption will be measured for the 4 days following their root canal using a Visual Analog Scale and Pain Pill Log, respectively. The alternative hypothesis is that patients undergoing treatment using the GentleWave will experience less pain postoperatively and will consume fewer pain pills.

A 12-month follow up with exam and radiographs will be completed to evaluate healing.

Conditions: Symptomatic Irreversible Pulpitis, Apical Periodontitis
Being tested: Multisonic vs Sonic activation of irrigants
Medical subject headings: Periapical Periodontitis

What participants receive

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

Multisonic vs Sonic activation of irrigantsDevice
Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.

Study groups in NCT04552132
Study group	Role	What they receive
GentleWave	Experimental	Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo. Receives: Device: Multisonic vs Sonic activation of irrigants
EndoActivator	Active comparator	Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona. Receives: Device: Multisonic vs Sonic activation of irrigants

What is being measured

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

24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 24 hours post-operative
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 24 hr postoperatively
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 48 hours post-operative
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 48 hours post-operative
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 72 hour post-operative
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 72 hours post-operative
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 96 hours post-operative
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Measured: 96 hours post-operative
Cone Beam Computed Tomography (CBCT) Healing Assessment
Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op.
Measured: 12 month recall
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report
Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters.
Measured: 12-month recall

Secondary outcomes (2)

Pain Pill Consumption for Patients Seen From 09/2021-06/2021
Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.
Measured: Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.
Pain Pill Consumption for Patients Seen From 07/2021-03/2022
Patients will be given 16 tabs of 600mg Ibuprofen and 16 tabs of 650mg Acetaminophen with instructions to take 1 pill every 6 hours as needed for pain. Patients will be given a Pain Pill Log to record each time they take a pill. The total number of pills consumed will be tabulated for each patient.
Measured: Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.

Timeline

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

30 Sep 202016 Mar 2022

First posted17 Sep 2020
Study start30 Sep 2020
Primary completion16 Mar 2022
Study completion16 Mar 2022

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.
Other trials for Symptomatic Irreversible PulpitisStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04552132
Sponsor's protocol ID: 31359
Status last verified: May 2023
First submitted: 13 Sep 2020
Last updated: 15 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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All Symptomatic Irreversible Pulpitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Pain and Healing of Molar Root Canal Teeth Using GentleWave vs. EndoActivator
ClinicalTrials.gov ID: NCT04552132
Acronym / sponsor ID: 31359
Conditions: Symptomatic Irreversible Pulpitis, Apical Periodontitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: St. Louis UniversityUniversity, hospital or other
Study start: 30 Sep 2020 (actual)
Primary completion: 16 Mar 2022 (actual)
Study completion: 16 Mar 2022 (actual)
First posted: 17 Sep 2020 (actual)
Results: Posted 15 Jun 2023

Clinical summary

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

A 12-month follow up with exam and radiographs will be completed to evaluate healing.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GentleWave	Experimental	Device: Multisonic vs Sonic activation of irrigantsPatients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.
EndoActivator	Active comparator	Device: Multisonic vs Sonic activation of irrigantsPatients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.

Key exclusion criteria (12 listed)

Minors
Pregnant women
Prisoners
Persons unable to adequately provide informed consent
Non-restorable teeth

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
Multisonic vs Sonic activation of irrigantsEnergy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.	Device	EndoActivator, GentleWave

Primary outcome

24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Time frame: 24 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Time frame: 24 hr postoperatively
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Time frame: 48 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Time frame: 48 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
72 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Time frame: 72 hour post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
72 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Time frame: 72 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
96 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021
Time frame: 96 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
96 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022
Time frame: 96 hours post-operative
Postoperative Pain will be measured by the patient placing a mark that they feel best represents their level of pain on a 100mm Visual Analog Scale with 'No Pain' on the left (at 0) and 'Worst Pain Possible' on the right (at 100).
Cone Beam Computed Tomography (CBCT) Healing Assessment
Time frame: 12 month recall
Each tooth root was classified as healed (no periapical radiolucency), healing (periapical radiolucency educed in size), or diseased (periapical radiolucency same size or larger). Pre-operative vs. post-operative periapical health evaluated using radiographs to compare the size of periapical radiolucencies present pre-op vs post-op.
Clinical Tooth Healing Classification Based on Clinical Examination and Patient Report
Time frame: 12-month recall
Teeth were classified as being clinically successful if the patient had no symptoms other than mild tenderness to percussion. Teeth were classified as failures if outside these parameters.

2 secondary outcomes

Pain Pill Consumption for Patients Seen From 09/2021-06/2021
Time frame: Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.
Pain Pill Consumption for Patients Seen From 07/2021-03/2022
Time frame: Patient to record on the Pain Pill Log each time that they take a pain pill during the 4 days following their root canal treatment.

Results and safety

Results posted to the registry on 15 Jun 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	31	26
EndoActivator	32	29

Primary outcome: 24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021

Time frame: 24 hours post-operative. Mean (Standard Deviation). Unit: score on a scale

Measure	GentleWave n = 12	EndoActivator n = 15
Value	14.75 (17.91)	16.23 (27.93)

GentleWave vs EndoActivator: p = 0.63, Fisher Exact

Population analysed: Participants seen from 09/2020-06/2021 that completed and returned their paperwork.

Primary outcome: 24 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022

Time frame: 24 hr postoperatively. Mean (Standard Deviation). Unit: score on a scale

Measure	GentleWave n = 14	EndoActivator n = 14
Value	12.86 (18.65)	17.00 (18.69)

GentleWave vs EndoActivator: p = 1.00, Fisher Exact

Population analysed: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

Primary outcome: 48 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021

Time frame: 48 hours post-operative. Mean (Standard Deviation). Unit: score on a scale

Measure	GentleWave n = 12	EndoActivator n = 15
Value	12.58 (18.71)	11.73 (19.58)

GentleWave vs EndoActivator: p = 0.63, Fisher Exact

Population analysed: Participants seen from 09/2020-06/2021 that completed and returned their paperwork

Primary outcome: 48 Hour Postoperative Pain for Patients Seen From 07/2021-03/2022

Time frame: 48 hours post-operative. Mean (Standard Deviation). Unit: score on a scale

Measure	GentleWave n = 14	EndoActivator n = 14
Value	6.86 (12.35)	10.07 (11.49)

GentleWave vs EndoActivator: p = 1.00, Fisher Exact

Population analysed: Participants seen from 07/2021-03/2022 that completed and returned their paperwork

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 10 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GentleWave	0 of 31 (0%)	0 of 31 (0%)	0 of 31
EndoActivator	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Symptomatic Irreversible Pulpitis

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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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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.

David Bingham, DDS principal investigator

Resident at the Center for Advanced Dental Education

Brian Judd, DDS principal investigator

Resident at the Center for Advanced Dental Education

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

Questions about this trial

What is this clinical trial studying?

A study testing Multisonic vs Sonic activation of irrigants in people with Symptomatic Irreversible Pulpitis and Apical Periodontitis, run by St. Louis University at 1 site 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 1 inclusion and 12 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 15 Jun 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?

24 Hour Postoperative Pain for Patients Seen From 09/2020-06/2021 (time frame: 24 hours post-operative). The study lists 10 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 NCT04552132.

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 15 Jun 2023.