Effect of Irrigation Activation on Periapical Healing
Conditions
Keywords
Irrigation activation, periapical healing
Brief summary
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.
Detailed description
The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up. A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values were statistically analyzed with the Wilcoxon test.
Interventions
PROCEDUREManual 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.
PROCEDUREPassive 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.
PROCEDURELaser 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.
Sponsors
Recep Tayyip Erdogan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients having single root mandibular teeth * Patients the diagnosis of chronic apical periodontitis, * Periapical index score of 3 and above, * Patients having good oral hygiene
Exclusion criteria
* Patients with systemic diseases (diabetes, hypertension, chronic liver disease, coagulation disorders), * Patients with bone metabolism disease and/or * Patients using drugs that affect bone metabolism (such as steroids, bisphosphonates) * Patients with a history of radiotherapy * Pregnant patients * Teeth with mobility of 2 or more, periodontal pocket depth of 5 mm or more, generalized chronic periodontitis, internal and external resorption, and/or vertical and horizontal root fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Lesion Volume at 12-months Follow-up | One year from the beginning of the study | 3D 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. |
| Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | One year from the beginning of the study | — |
Countries
Turkey (Türkiye)
Participant flow
Pre-assignment details
Of 97 enrolled participants, 70 met inclusion criteria and randomized to irrrigation protocols.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 14 |
| 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. | 14 |
| Non-activated Control No activation protocol was applied during irrigation. | 14 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 | 1 | 6 |
Baseline characteristics
| Characteristic | Manual Dynamic Activation | Passive Ultrasonic Activation | Laser Activation | Non-activated Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 34.071 Years | 38 Years | 41.928 Years | 37.073 Years | 37.768 Years |
| Pre-operative lesion volumes | 193.936 mm3 STANDARD_DEVIATION 29.441 | 158.343 mm3 STANDARD_DEVIATION 40.275 | 168.371 mm3 STANDARD_DEVIATION 37.904 | 172.2 mm3 STANDARD_DEVIATION 41.707 | 173.212 mm3 STANDARD_DEVIATION 37.331 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Turkey | 14 participants | 14 participants | 14 participants | 14 participants | 56 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 8 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 6 Participants | 10 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up
Time frame: One year from the beginning of the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manual dynamic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Totally healed | 3 participant |
| Manual dynamic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Reduced | 9 participant |
| Manual dynamic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Unchanged | 2 participant |
| Manual dynamic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Enlarged | 0 participant |
| Passive ultrasonic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Reduced | 13 participant |
| Passive ultrasonic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Unchanged | 0 participant |
| Passive ultrasonic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Enlarged | 0 participant |
| Passive ultrasonic activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Totally healed | 1 participant |
| Laser activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Unchanged | 1 participant |
| Laser activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Reduced | 9 participant |
| Laser activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Enlarged | 0 participant |
| Laser activation | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Totally healed | 4 participant |
| Non-activated Control | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Enlarged | 0 participant |
| Non-activated Control | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Reduced | 8 participant |
| Non-activated Control | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Totally healed | 3 participant |
| Non-activated Control | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Unchanged | 3 participant |
Primary
Percentage Change in Lesion Volume at 12-months Follow-up
3D 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.
Time frame: One year from the beginning of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual dynamic activation | Percentage Change in Lesion Volume at 12-months Follow-up | 80.429 percent change | Standard Deviation 28.294 |
| Passive ultrasonic activation | Percentage Change in Lesion Volume at 12-months Follow-up | 85.429 percent change | Standard Deviation 8.635 |
| Laser activation | Percentage Change in Lesion Volume at 12-months Follow-up | 86.929 percent change | Standard Deviation 23.332 |
| Non-activated Control | Percentage Change in Lesion Volume at 12-months Follow-up | 74.571 percent change | Standard Deviation 36.515 |
p-value: <0.05Kruskal-Wallis