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OpenTrials
Completed

NCT Number: NCT04552132

Postoperative Pain and Healing in Teeth Treated With GentleWave or 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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis Apical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis University Center for Advanced Dental Education

St Louis, Missouri, 63104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multisonic vs Sonic activation of irrigants

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 17, 2020
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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