- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635515
Occurrence of Post-op Pain Following Gentlewave
Post-operative Pain Following Treatment Using the Gentlewave System
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota, School of Dentistry Department of Graduate Endodontics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Protocol (Control) Group
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.
|
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.
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Active Comparator: Gentlewave Treatment Group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Post-operative Pain (2018-2019)
Time Frame: 6 hours
|
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. |
6 hours
|
Level of Post-operative Pain (2018-2019)
Time Frame: 24 hours
|
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. |
24 hours
|
Level of Post-operative Pain (2018-2019)
Time Frame: 72 hours
|
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. |
72 hours
|
Level of Post-operative Pain (2018-2019)
Time Frame: 168 hours
|
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. |
168 hours
|
Level of Post-operative Pain (2020-2021)
Time Frame: 6 hours
|
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. |
6 hours
|
Level of Post-operative Pain (2020-2021)
Time Frame: 24 hours
|
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. |
24 hours
|
Level of Post-operative Pain (2020-2021)
Time Frame: 72 hours
|
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. |
72 hours
|
Level of Post-operative Pain (2020-2021)
Time Frame: 168 hours
|
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. |
168 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of post-operative pain
Time Frame: 6, 24, 72, and 168 hours
|
To determine the severity of pain, should it occur, based on a Visual Analog Scale for pain assessment.
The scale will range from 0 to 100 mm, higher scores representing a worst or more severe outcome.
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6, 24, 72, and 168 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- Schilder H. Cleaning and shaping the root canal. Dent Clin North Am. 1974 Apr;18(2):269-96. No abstract available.
- 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
- 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.
- 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.
- 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.
- Hulsmann M, Rodig T, Nordemeyer S. Complications during root canal irrigation. Endod Topics; 16: 27-63
- 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.
- Sonendo. The Gentlewave system procedure guide. 2017
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DENT-2018-26373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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