search
Back to results

Occurrence of Post-op Pain Following Gentlewave

Primary Purpose

Root Canal Infection, Endodontic Disease, Endodontic Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gentlewave
Standard Endodontic Protocol
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The target population of the study includes patients needing endodontic treatment in the University of Minnesota Graduate Endodontics clinic, ages 18+. Vulnerable populations that will be included in the study are members of the military and those individuals from an undervalued or disenfranchised social group.

Exclusion Criteria:

  • Patients with teeth that have root apices in the maxillary sinus, teeth with immature root apices, and teeth with insufficient coronal tooth structure will be excluded. For the purposes of this study children, pregnant women, prisoners, and adults lacking the capacity to consent will be excluded.

Sites / Locations

  • University of Minnesota, School of Dentistry Department of Graduate Endodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard Protocol (Control) Group

Gentlewave Treatment Group

Arm Description

Patients will be given a VAS scale to record their highest level of pain 6 hrs prior to treatment. The standard endodontic protocol will be followed. The same VAS scale from pretreatment will be used to record pain level at 6, 24, 72, and 168 hours post-treatment.

Patients will be given a VAS scale to record their highest level of pain 6 hrs prior to treatment. The standard endodontic protocol will be followed through working length verification. For the Gentlewave treatment group, each canal will be shaped to a canal size of 20.06 and to 0.5 - 1mm short of the apical terminus. An occlusal platform will be prepared using the Kool-dam material recommended by Sonendo. The Gentlewave system will be held on the tooth by the clinician and will cycle through five minutes of 3% sodium hypochlorite, two minutes of 8% EDTA, and a final rinse of distilled water. Canals will be obturated with root canal sealer and gutta-percha. The same VAS scale from pretreatment to take home and asked to record their level of pain at 6, 24, 72, and 168 hours post-treatment.

Outcomes

Primary Outcome Measures

Level of Post-operative Pain (2018-2019)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2018-2019)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2018-2019)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2018-2019)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2020-2021)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2020-2021)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2020-2021)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Level of Post-operative Pain (2020-2021)
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2018
Last Updated
January 19, 2023
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT03635515
Brief Title
Occurrence of Post-op Pain Following Gentlewave
Official Title
Post-operative Pain Following Treatment Using the Gentlewave System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical study that will investigate the occurrence of post-operative discomfort following the use of the Gentlewave System for root canal disinfection and irrigation. Assessment of discomfort level will be via a visualized analog pain scale.
Detailed Description
Once a tooth reaches a level of inflammation where healing can no longer occur or when the pulp space begins to go through necrosis, root canal treatment is indicated. The goal of root canal therapy is to clean, shape, disinfect, and obturate all canal systems within the tooth. Schilder's mechanical and biological objectives for cleaning and shaping includes: preparing a continuous tapering root canal funnel from access to apex, cross-sectional diameters should be wider at every point as you move coronally, the preparation should occupy as may planes as presented by the original canal and should follow the shape of the original canal, the apical foramen should remain in it is original spatial relationship to bone and to root surface, the apical opening should be kept as small as practical in all cases, complete cleaning and shaping in one appointment, procedures should be confined to the roots themselves, necrotic debris should not be forced beyond the foramina, all tissues should be removed from root canal space, and sufficient space for intracanal medicaments and irrigation should be created. Traditionally, the standard protocol for cleaning and shaping is completed using multiple hand or rotary files. Siqueira discovered that the factors that are commonly responsible for post-operative or interappointment pain include mechanical preparation and obturation beyond the apex, bacterial insults not present in the primary infection, and chemical extrusion of irrigant materials beyond the apex. Post-operative pain can occur hours to days following root canal procedures. Irrigation dissolves organic material and kills microbes. It also helps prevent the binding of instruments, improves the cutting effectiveness of files, dissolves tissue, and cools the instrument and tooth. The most common endodontic irrigant is sodium hypochlorite. Sodium hypochlorite is an alkaline fluid with a pH of approximately 11-12. It hydrolyzes proteins and causes hemolysis of red blood cells which leads to the dissolution of vital, as well as necrotic tissue. Upon contact of organic debris, hypochlorus acid forms which disrupts bacterial metabolism by oxidizing the sulfhydryl group of bacterial enzymes. The purpose of this study is to determine whether a new treatment modality for cleaning and disinfecting the root canal system will significantly affect the occurrence and severity of post-operative pain. Patients will be randomly divided into two groups, control and research. The control group will have the standard root canal procedure. The research group will have a root canal treatment that includes irrigation and disinfection with the Gentlewave system, thus eliminating the need for multiple rotatory files and multiple irrigation steps. Patients will be asked to complete a visual analog pain scale rating for pretreatment pain, as well as the same visual assessment scale for pain 6, 24, 72, & 168 hours following treatment. The results of the study should show that following Gentlewave treatment patients will experience less severe post-operative pain, if any at all. The findings should support a treatment modality that retains tooth structure while completely removing necrotic debris and bacteria, as well as causing minimal to no post-operative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection, Endodontic Disease, Endodontic Inflammation, Post-Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be asked to indicate their peak pain level in the twenty-four hours prior to the appointment using a visual analog scale (VAS). The VAS scale will consist of a 100mm line where 0 equals 'no pain' and 100 equals the 'worst pain imaginable'. Patients will be divided into one of two treatment groups, either standard cleaning protocol or Gentlewave irrigation. Patient demographics, anesthesia, cleaning and shaping instruments, irrigation technique, and obturation method and material will be recorded, along with the number of appointments, extent of treatment rendered, and the occurrence of over-instrumentation or overfill of obturation material. Once obturation is completed, patients will be given the same VAS scale to take home and asked to record their level of pain at 6, 24, 72, and 168 hours post-treatment.
Masking
Participant
Masking Description
Participants will not know which study arm/intervention group they will be assigned to.
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Protocol (Control) Group
Arm Type
Active Comparator
Arm Description
Patients will be given a VAS scale to record their highest level of pain 6 hrs prior to treatment. The standard endodontic protocol will be followed. The same VAS scale from pretreatment will be used to record pain level at 6, 24, 72, and 168 hours post-treatment.
Arm Title
Gentlewave Treatment Group
Arm Type
Active Comparator
Arm Description
Patients will be given a VAS scale to record their highest level of pain 6 hrs prior to treatment. The standard endodontic protocol will be followed through working length verification. For the Gentlewave treatment group, each canal will be shaped to a canal size of 20.06 and to 0.5 - 1mm short of the apical terminus. An occlusal platform will be prepared using the Kool-dam material recommended by Sonendo. The Gentlewave system will be held on the tooth by the clinician and will cycle through five minutes of 3% sodium hypochlorite, two minutes of 8% EDTA, and a final rinse of distilled water. Canals will be obturated with root canal sealer and gutta-percha. The same VAS scale from pretreatment to take home and asked to record their level of pain at 6, 24, 72, and 168 hours post-treatment.
Intervention Type
Device
Intervention Name(s)
Gentlewave
Intervention Description
The Gentlewave system from Sonendo is a FDA cleared root canal irrigation device that uses broad spectrum acoustic energy, internally degassed distilled water, 3% NaOCl, and 8% EDTA to allow for a more thorough cleaning within the tooth. The fluids work to remove necrotic tissue, debris, biofilm, and bacteria while leaving dentin intact and preserving tooth structure. The Gentlewave irrigation replaces the NaOCl ultrasonic activation and EDTA steps of the standard endodontic protocol. Use of the Gentlewave system is contraindicated in teeth with immature apices, teeth with insufficient coronal structure, and teeth with root apices extending into the maxillary sinus.
Intervention Type
Procedure
Intervention Name(s)
Standard Endodontic Protocol
Intervention Description
The tooth will be sufficiently anesthetized with local anesthetic. The tooth will be rubber dam isolated. The pulp chamber will be accessed removing all caries, defective restorations, and defective crowns. EAL and radiographs will be used to determine the working length of each canal, all canals will be cleaned and shaped using rotary files to at least a size 25.04 canal size to within 0.5 to 1 mm of the apical terminus. Between each file 5.25% NaOCl will be used to disinfect and clear the canals of debris. A final passive ultrasonic activation of NaOCl will be done for 30 seconds per canal. Each canal will then soak in 17% EDTA for 1 minute, rinsed in 5.25% NaOCl, and finally undergo a final rinse of 95% ethanol. Canals will be obturated with root canal sealer and gutta-percha.
Primary Outcome Measure Information:
Title
Level of Post-operative Pain (2018-2019)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
6 hours
Title
Level of Post-operative Pain (2018-2019)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
24 hours
Title
Level of Post-operative Pain (2018-2019)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
72 hours
Title
Level of Post-operative Pain (2018-2019)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
168 hours
Title
Level of Post-operative Pain (2020-2021)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
6 hours
Title
Level of Post-operative Pain (2020-2021)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
24 hours
Title
Level of Post-operative Pain (2020-2021)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
72 hours
Title
Level of Post-operative Pain (2020-2021)
Description
To determine whether treatment with the Gentlewave system will significantly change the level of post-operative pain following endodontic treatment as measured by the VAS scale. Pain measurements were made using a 0-100 VAS- NRS. The '0' mark represented 'no pain' and the '100' mark represented 'the worst pain imaginable'. Scores 0-19 represented low pain, 20-39 was mild pain, 40-59 was moderate pain, 60-79 was high pain, and 80-100 was very high or severe pain. For this study, scores in the very high range were considered severe pain.
Time Frame
168 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The target population of the study includes patients needing endodontic treatment in the University of Minnesota Graduate Endodontics clinic, ages 18+. Vulnerable populations that will be included in the study are members of the military and those individuals from an undervalued or disenfranchised social group. Exclusion Criteria: Patients with teeth that have root apices in the maxillary sinus, teeth with immature root apices, and teeth with insufficient coronal tooth structure will be excluded. For the purposes of this study children, pregnant women, prisoners, and adults lacking the capacity to consent will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Ordinola Zapata, DDS, MS, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota, School of Dentistry Department of Graduate Endodontics
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan on sharing IPD
Citations:
PubMed Identifier
4522570
Citation
Schilder H. Cleaning and shaping the root canal. Dent Clin North Am. 1974 Apr;18(2):269-96. No abstract available.
Results Reference
background
Citation
Peters OA, Peters CI, Basrani B. Cleaning and shaping the root canal system. In: Hargreaves KM, Berman LH, EDS. Cohen's pathway of the pulp. 11th ed. St. Louis: Mosby, Inc. 2016: 209-279
Results Reference
background
PubMed Identifier
12823700
Citation
Siqueira JF Jr. Microbial causes of endodontic flare-ups. Int Endod J. 2003 Jul;36(7):453-63. doi: 10.1046/j.1365-2591.2003.00671.x.
Results Reference
background
PubMed Identifier
22505897
Citation
Gotler M, Bar-Gil B, Ashkenazi M. Postoperative pain after root canal treatment: a prospective cohort study. Int J Dent. 2012;2012:310467. doi: 10.1155/2012/310467. Epub 2012 Mar 15.
Results Reference
background
PubMed Identifier
24651335
Citation
Haapasalo M, Shen Y, Wang Z, Gao Y. Irrigation in endodontics. Br Dent J. 2014 Mar;216(6):299-303. doi: 10.1038/sj.bdj.2014.204.
Results Reference
background
PubMed Identifier
22152617
Citation
Dutner J, Mines P, Anderson A. Irrigation trends among American Association of Endodontists members: a web-based survey. J Endod. 2012 Jan;38(1):37-40. doi: 10.1016/j.joen.2011.08.013. Epub 2011 Sep 21.
Results Reference
background
Citation
Hulsmann M, Rodig T, Nordemeyer S. Complications during root canal irrigation. Endod Topics; 16: 27-63
Results Reference
background
PubMed Identifier
18081810
Citation
Pontes F, Pontes H, Adachi P, Rodini C, Almeida D, Pinto D Jr. Gingival and bone necrosis caused by accidental sodium hypochlorite injection instead of anaesthetic solution. Int Endod J. 2008 Mar;41(3):267-70. doi: 10.1111/j.1365-2591.2007.01340.x. Epub 2007 Dec 10.
Results Reference
background
Citation
Sonendo. The Gentlewave system procedure guide. 2017
Results Reference
background
PubMed Identifier
11552152
Citation
Mattscheck DJ, Law AS, Noblett WC. Retreatment versus initial root canal treatment: factors affecting posttreatment pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Sep;92(3):321-4. doi: 10.1067/moe.2001.115135.
Results Reference
background
PubMed Identifier
15230906
Citation
Menhinick KA, Gutmann JL, Regan JD, Taylor SE, Buschang PH. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Int Endod J. 2004 Aug;37(8):531-41. doi: 10.1111/j.1365-2591.2004.00836.x.
Results Reference
background
PubMed Identifier
29336878
Citation
Sigurdsson A, Garland RW, Le KT, Rassoulian SA. Healing of Periapical Lesions after Endodontic Treatment with the GentleWave Procedure: A Prospective Multicenter Clinical Study. J Endod. 2018 Mar;44(3):510-517. doi: 10.1016/j.joen.2017.12.004. Epub 2018 Jan 12.
Results Reference
background

Learn more about this trial

Occurrence of Post-op Pain Following Gentlewave

We'll reach out to this number within 24 hrs