Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-03-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Symptomatic Irreversible Pulpitis Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GentleWave

Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.

Group Type EXPERIMENTAL

Multisonic vs Sonic activation of irrigants

Intervention Type DEVICE

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

EndoActivator

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.

Group Type ACTIVE_COMPARATOR

Multisonic vs Sonic activation of irrigants

Intervention Type DEVICE

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

Interventions

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Multisonic vs Sonic activation of irrigants

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• 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.

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes