Trial Outcomes & Findings for Occurrence of Post-op Pain Following Gentlewave (NCT NCT03635515)
NCT ID: NCT03635515
Last Updated: 2023-02-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
6 hours
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Protocol (Control) Group
n=38 Participants
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.
|
Gentlewave Treatment Group
n=38 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=38 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=38 Participants
|
28 Participants
n=38 Participants
|
56 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=38 Participants
|
10 Participants
n=38 Participants
|
20 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=38 Participants
|
18 Participants
n=38 Participants
|
36 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=38 Participants
|
20 Participants
n=38 Participants
|
40 Participants
n=76 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 6 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=20 Participants
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.
|
Gentlewave Treatment Group
n=20 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2018-2019)
|
23.2 score on VAS scale
Standard Deviation 25.38
|
11.56 score on VAS scale
Standard Deviation 9.94
|
PRIMARY outcome
Timeframe: 24 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=18 Participants
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.
|
Gentlewave Treatment Group
n=18 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2018-2019)
|
19.33 score on VAS scale
Standard Deviation 21.46
|
7.78 score on VAS scale
Standard Deviation 10.88
|
PRIMARY outcome
Timeframe: 72 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=18 Participants
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.
|
Gentlewave Treatment Group
n=18 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2018-2019)
|
13.11 score on VAS scale
Standard Deviation 18.56
|
5 score on VAS scale
Standard Deviation 7.28
|
PRIMARY outcome
Timeframe: 168 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=18 Participants
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.
|
Gentlewave Treatment Group
n=18 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2018-2019)
|
5.22 score on VAS scale
Standard Deviation 10.46
|
2.78 score on VAS scale
Standard Deviation 7.32
|
PRIMARY outcome
Timeframe: 6 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=20 Participants
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.
|
Gentlewave Treatment Group
n=20 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2020-2021)
|
22 score on VAS scale
Interval 13.0 to 30.0
|
24 score on VAS scale
Interval 15.0 to 33.0
|
PRIMARY outcome
Timeframe: 24 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=20 Participants
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.
|
Gentlewave Treatment Group
n=20 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2020-2021)
|
25 score on VAS scale
Interval 16.0 to 34.0
|
21 score on VAS scale
Interval 12.0 to 30.0
|
PRIMARY outcome
Timeframe: 72 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=20 Participants
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.
|
Gentlewave Treatment Group
n=20 Participants
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.
|
|---|---|---|
|
Level of Post-operative Pain (2020-2021)
|
17 score on VAS scale
Interval 9.0 to 26.0
|
15 score on VAS scale
Interval 6.0 to 23.0
|
PRIMARY outcome
Timeframe: 168 hoursTo 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.
Outcome measures
| Measure |
Standard Protocol (Control) Group
n=20 Participants
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.
|
Gentlewave Treatment Group
n=20 Participants
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.
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Level of Post-operative Pain (2020-2021)
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8 score on VAS scale
Interval 0.0 to 16.0
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6 score on VAS scale
Interval 0.0 to 14.0
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Adverse Events
Standard Protocol (Control) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gentlewave Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ronald Ordinola Zapata DDS, MS, PhD
University of Minnesota
Phone: (612) 624-9900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place