Root Canal Infection, Endodontic Disease, Endodontic Inflammation, Post-Operative Pain
Conditions
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.
Interventions
DEVICEGentlewave
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.
PROCEDUREStandard Endodontic Protocol
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know which study arm/intervention group they will be assigned to.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Post-operative Pain (2018-2019) | 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. |
| Level of Post-operative Pain (2020-2021) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Standard Endodontic Protocol: 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. | 38 |
| 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.
Gentlewave: 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. | 38 |
| Total | 76 |
Baseline characteristics
| Characteristic | Standard Protocol (Control) Group | Gentlewave Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 28 Participants | 56 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
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.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2018-2019) | 23.2 score on VAS scale | Standard Deviation 25.38 |
| Gentlewave Treatment Group | Level of Post-operative Pain (2018-2019) | 11.56 score on VAS scale | Standard Deviation 9.94 |
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2018-2019) | 19.33 score on VAS scale | Standard Deviation 21.46 |
| Gentlewave Treatment Group | Level of Post-operative Pain (2018-2019) | 7.78 score on VAS scale | Standard Deviation 10.88 |
Primary
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.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2018-2019) | 13.11 score on VAS scale | Standard Deviation 18.56 |
| Gentlewave Treatment Group | Level of Post-operative Pain (2018-2019) | 5 score on VAS scale | Standard Deviation 7.28 |
Primary
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.
Time frame: 168 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2018-2019) | 5.22 score on VAS scale | Standard Deviation 10.46 |
| Gentlewave Treatment Group | Level of Post-operative Pain (2018-2019) | 2.78 score on VAS scale | Standard Deviation 7.32 |
Primary
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.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2020-2021) | 22 score on VAS scale |
| Gentlewave Treatment Group | Level of Post-operative Pain (2020-2021) | 24 score on VAS scale |
Primary
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2020-2021) | 25 score on VAS scale |
| Gentlewave Treatment Group | Level of Post-operative Pain (2020-2021) | 21 score on VAS scale |
Primary
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.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2020-2021) | 17 score on VAS scale |
| Gentlewave Treatment Group | Level of Post-operative Pain (2020-2021) | 15 score on VAS scale |
Primary
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.
Time frame: 168 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Protocol (Control) Group | Level of Post-operative Pain (2020-2021) | 8 score on VAS scale |
| Gentlewave Treatment Group | Level of Post-operative Pain (2020-2021) | 6 score on VAS scale |