Trial Outcomes & Findings for Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions (NCT NCT06204887)
NCT ID: NCT06204887
Last Updated: 2025-12-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
One year from the beginning of the study
Results posted on
2025-12-24
Participant Flow
Of 97 enrolled participants, 70 met inclusion criteria and randomized to irrrigation protocols.
Participant milestones
| Measure |
Manual Dynamic Activation
Manual dynamic activation: The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
|
Passive Ultrasonic Activation
Passive ultrasonic activation: A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
|
Laser Activation
Laser activation: A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
|
Non-activated Control
No activation protocol was applied during irrigation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
15
|
20
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
6
|
Reasons for withdrawal
| Measure |
Manual Dynamic Activation
Manual dynamic activation: The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
|
Passive Ultrasonic Activation
Passive ultrasonic activation: A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
|
Laser Activation
Laser activation: A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
|
Non-activated Control
No activation protocol was applied during irrigation.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
1
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Manual Dynamic Activation
n=14 Participants
Manual dynamic activation: The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
|
Passive Ultrasonic Activation
n=14 Participants
Passive ultrasonic activation: A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
|
Laser Activation
n=14 Participants
Laser activation: A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
|
Non-activated Control
n=14 Participants
No activation protocol was applied during irrigation.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.071 Years
n=14 Participants
|
38 Years
n=14 Participants
|
41.928 Years
n=14 Participants
|
37.073 Years
n=14 Participants
|
37.768 Years
n=56 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
8 Participants
n=14 Participants
|
4 Participants
n=14 Participants
|
22 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
10 Participants
n=14 Participants
|
34 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
56 participants
n=56 Participants
|
|
Pre-operative lesion volumes
|
193.936 mm3
STANDARD_DEVIATION 29.441 • n=14 Participants
|
158.343 mm3
STANDARD_DEVIATION 40.275 • n=14 Participants
|
168.371 mm3
STANDARD_DEVIATION 37.904 • n=14 Participants
|
172.2 mm3
STANDARD_DEVIATION 41.707 • n=14 Participants
|
173.212 mm3
STANDARD_DEVIATION 37.331 • n=56 Participants
|
PRIMARY outcome
Timeframe: One year from the beginning of the study3D volumes pre-operatively and at the end of 1 year were measured using the segmentation technique by slicing the image at 0.09 mm intervals. The borders of the lesion were determined with gray scale. The defined volume boundaries were automatically filled by bubbles until the entire defect was filled completely. If necessary, manual correction was applied at this stage of lesion volume measurements, allowing for small individual additions or subtractions. At the end, the well-defined size of the lesion could be visualized in 3D. After finishing the process, the software depicted the exact volume of the defects in mm3.The volume data were compared with the preoperative CBCT measurements in each case. The primary healing of the periapical tissues was assessed, volume changes were measured, and the long-term outcomes of the procedures were compared using percentage of the lesion volume change.
Outcome measures
| Measure |
Manual dynamic activation
n=14 Participants
Manual dynamic activation: The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
|
Passive ultrasonic activation
n=14 Participants
Passive ultrasonic activation: A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
|
Laser activation
n=14 Participants
Laser activation: A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
|
Non-activated Control
n=14 Participants
No activation protocol was applied during irrigation.
|
|---|---|---|---|---|
|
Percentage Change in Lesion Volume at 12-months Follow-up
|
80.429 percent change
Standard Deviation 28.294
|
85.429 percent change
Standard Deviation 8.635
|
86.929 percent change
Standard Deviation 23.332
|
74.571 percent change
Standard Deviation 36.515
|
PRIMARY outcome
Timeframe: One year from the beginning of the studyOutcome measures
| Measure |
Manual dynamic activation
n=14 Participants
Manual dynamic activation: The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.
|
Passive ultrasonic activation
n=14 Participants
Passive ultrasonic activation: A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.
|
Laser activation
n=14 Participants
Laser activation: A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.
|
Non-activated Control
n=14 Participants
No activation protocol was applied during irrigation.
|
|---|---|---|---|---|
|
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Enlarged
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Unchanged
|
2 participant
|
0 participant
|
1 participant
|
3 participant
|
|
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Totally healed
|
3 participant
|
1 participant
|
4 participant
|
3 participant
|
|
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Reduced
|
9 participant
|
13 participant
|
9 participant
|
8 participant
|
Adverse Events
Manual Dynamic Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Ultrasonic Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Laser Activation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-activated Control
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place