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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual dynamic activation | Experimental |
| |
| Passive ultrasonic activation | Experimental |
| |
| Laser activation | Experimental |
| |
| Non-activated Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual dynamic activation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One year from the beginning of the study |
| Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | One year from the beginning of the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahter Şanal Çıkman | Recep Tayyip Erdogan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan University | Rize | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38878107 | Derived | Dogan MU, Aricioglu B, Kose TE, Cikman AS, Oksuzer MC. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376. doi: 10.1007/s00784-024-05758-4. |
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Of 97 enrolled participants, 70 met inclusion criteria and randomized to irrrigation protocols.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Non-activated Control | No activation protocol was applied during irrigation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent change | One year from the beginning of the study |
|
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Death, serious adverse events, and other(non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The follow-up period of the study was 1 year, which may have limited our ability to obtain definitive evidence of lesion changes in the long term.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahter Şanal Çıkman | Recep Tayyip Erdogan University | 05069293341 | ahter.sanalcikman@erdogan.edu.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2024 | May 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2024 | May 17, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 16, 2024 | May 13, 2025 | ICF_002.pdf |
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| Passive ultrasonic activation | Procedure | 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 | Procedure | 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. |
|
| 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. |
| BG002 | 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. |
| BG003 | Non-activated Control | No activation protocol was applied during irrigation. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pre-operative lesion volumes | Mean | Standard Deviation | mm3 |
|
| 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Non-activated Control | No activation protocol was applied during irrigation. |
|
|
|
| Primary | Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up | Posted | Number | participant | One year from the beginning of the study |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Non-activated Control | No activation protocol was applied during irrigation. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Male |
|
| Reduced |
|
| Unchanged |
|
| Enlarged |
|