Clinical trial NCT03635515: Occurrence of Post-op Pain Following Gentlewave
Official title: Post-operative Pain Following Treatment Using the Gentlewave System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Canal Infection
Endodontic Disease
Endodontic Inflammation
Post-Operative Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Level of Post-operative Pain (2018-2019)
timeFrame: 6 hours
measure: Level of Post-operative Pain (2018-2019)
timeFrame: 24 hours
measure: Level of Post-operative Pain (2018-2019)
timeFrame: 72 hours
measure: Level of Post-operative Pain (2018-2019)
timeFrame: 168 hours
measure: Level of Post-operative Pain (2020-2021)
timeFrame: 6 hours
measure: Level of Post-operative Pain (2020-2021)
timeFrame: 24 hours
measure: Level of Post-operative Pain (2020-2021)
timeFrame: 72 hours
measure: Level of Post-operative Pain (2020-2021)
timeFrame: 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Dentistry Department of Graduate Endodontics
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ronald Ordinola Zapata, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sonendo. The Gentlewave system procedure guide. 2017
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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.
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