Trial Outcomes & Findings for A First in Human Study to Compare Feasibility of Inertial Cavitation Irrigation to SNI in Root Canal Treatment. (NCT NCT05374434)

Results Overview

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

6 hours

Results posted on

2024-07-25

Participant Flow

A total of 10 participants who met all inclusion criteria and no exclusion criteria were randomized at 1 site to treatment between May 10, 2022 and May 31, 2022.

Subjects were randomized 1:1 on Study Day 0 to receive treatment either by manual irrigation with sodium hypochlorite NaOCl or by inertial cavitation-generating device.

Participant milestones

Participant milestones
Measure	Conventional Irrigation Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.	Total n=10 Participants Total of all reporting groups
Age, Customized Mean age of participants	29.8 years STANDARD_DEVIATION 13.8 • n=5 Participants	26.8 years STANDARD_DEVIATION 6.61 • n=5 Participants	28.3 years STANDARD_DEVIATION 10.3 • n=10 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=5 Participants	5 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=5 Participants	5 Participants n=10 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	5 Participants n=5 Participants	5 Participants n=5 Participants	10 Participants n=10 Participants

PRIMARY outcome

Timeframe: 6 hours

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Outcome measures

Outcome measures
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Clinical Postoperative Pain	30.5 score on a scale Standard Deviation 10.6	20.6 score on a scale Standard Deviation 21.25

PRIMARY outcome

Timeframe: 24 hours

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Outcome measures

Outcome measures
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Clinical Postoperative Pain	15.7 score on a scale Standard Deviation 8.36	21.2 score on a scale Standard Deviation 18.6

PRIMARY outcome

Timeframe: 48 hours

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Outcome measures

Outcome measures
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Clinical Postoperative Pain	10.94 score on a scale Standard Deviation 8.82	12 score on a scale Standard Deviation 16.43

PRIMARY outcome

Timeframe: 72 hours

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Outcome measures

Outcome measures
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Clinical Postoperative Pain	10.4 score on a scale Standard Deviation 10.32	12 score on a scale Standard Deviation 16.43

PRIMARY outcome

Timeframe: 1 week

Pain intensity levels were graded using Visual Analog Scale (VAS). This scale is a horizontal 100 mm bar, marked in every 10mm with two ends. One end (0) indicated "no pain" and the other end (100) indicated "worst pain possible". Categorization of pain scores is as follows: 0-4 mm = No Pain, 5-44 mm = Mild Pain, 45-74 mm = Moderate Pain, 75-100 mm = severe pain.

Outcome measures

Outcome measures
Measure	Conventional Irrigation n=5 Participants Root canal cleaning will be performed by manual irrigation with sodium hypochlorite NaOCl solution. Conventional irrigation: The participant will be treated by manual irrigation with sodium hypochlorite NaOCl.	Inertial Cavitation n=5 Participants Root canal cleaning will be performed by inertial cavitation-generating device. Inertial cavitation: The participant will be treated by inertial cavitation-generating device, that generates hydraulic cavitation to clean root canals deeper and more effectively than other existing systems.
Clinical Postoperative Pain	11.58 score on a scale Standard Deviation 16.2	4 score on a scale Standard Deviation 8.94

Adverse Events

Conventional Irrigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inertial Cavitation

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

Mark Bispinghoff

Lumendo

Phone: +41 44 589 68 02

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place