Clinical Investigation of the Effectiveness of Laser-activated Photoacoustic Flow in One-visit Revision of Teeth With Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
The main objective of the clinical randomized study is to examine the effectiveness laser-activated irrigation (LAI) on the removal of intracanal microorganisms and the healing of an inflammatory periapical lesion of a tooth after a one-visit revision of teeth with apical periodontitis.
The main questions are:
- Does LAI reduces the occurrence of postoperative pain, compared with sonic-activated irrigation?
- Is antimicrobial efficacy of LAI greater than the antimicrobial efficacy of sonic-activated irrigation?
- Is periapical lesion healing after LAI application better than after sonic-activated irrigation?
Researcher will compare LAI and sonic-activated irrigation in patients with signs and symptoms of chronic apical periodontitis requiring revision. Participants will be assigned to two experimental groups depending on the final root canal disinfection protocol. Postoperative pain will be assessed via a questionnaire that participants will receive after the treatment and which they will complete over a period of seven days. Microbiological samples will be collected from the root canal and real-time PCR analysis will be performed to evaluate antimicrobial efficacy. Assessment of periapical lesion healing will be performed by comparing CBCT scans obtained before the treatment and one year after.
详细描述
Introduction:
Endodontic treatment of teeth involves thorough mechanical removal of microorganisms, necrotic and infected pulp tissue, and chemical disinfection of the endodontic space. Due to the complex morphology of the endodontic space, which includes lateral canals, isthmuses, and apical bifurcations, more than a third of the root canal remains untreated after mechanical treatment, so chemical disinfection is an indispensable addition to mechanical treatment. The work of instruments in the root canal creates a residual layer on the canal walls, and dentin debris created by instrumentation accumulates in the irregularities of the canal and serves as an ideal refuge for remaining bacteria. In addition, the residual layer on the dentin walls can prevent the penetration of irrigant and filler into the dentinal tubules. Therefore, abundant irrigation with irrigant is essential for removing dentin chips from the root canal, but also the residual layer from its walls.
Ultrasonic and laser-activated disinfection are increasingly used to improve the depth of penetration of the irrigant used and thus reduce persistent periradicular inflammation. However a systematic review from 2023 that laser-activated disinfection is significantly better at reducing the number of microorganisms and removing residual layer and dentine debris compared to ultrasonically activated disinfection. It is believed that laser-activated disinfection improves the effectiveness of irrigant in disinfecting the endodontic space by creating secondary cavitations through expansion and subsequent implosion of the liquid. Er:YAG lasers use laser energy to create acoustic waves that move the irrigant and thus improve its flow inside the root canal, which is especially true for the PIPS technique (photon-induced photoacoustic streaming). It is shown that laser-activated disinfection, in vitro, can reduce the number of bacteria in infected canals by 99.5%. Modalities of the Er:YAG laser, such as SWEEPS (shock wave enhanced emission photoacoustic streaming) and SSP (super short pulse), create a precise concentration of shock waves during irrigation, which enable the washing agent to penetrate deeper into the lateral canals and microscopic tubules, thereby increasing the effectiveness of disinfection. Because of the above, SWEEPS/SSP modalities have significant advantages during endodontic treatment, especially in teeth with complicated root canal morphology.
However, although in vitro studies show that laser-activated irrigation (LAI) is superior to other methods in removing intracanal microorganisms, there are still very few clinical studies. Clinical studies show that the healing of periapical lesions after one year on single-rooted teeth and premolars is the same for all irrigation techniques. However, a higher percentage of healing has also been reported when using the SWEEPS modality. It is also emphasized the need for additional research that would study the effectiveness of LAI in multi-rooted teeth, considering their more pronounced morphology of the endodontic space, on which pulsed laser modalities could be more effective.
There is also increasing emphasis on the use of cone-beam computed tomography (CBCT) in future studies to assess prognostic factors affecting the outcome of root canal treatment. Periapical radiographs show a more favorable outcome of healing of periapical lesions compared to CBCT, which significantly affects the correct assessment of treatment success. The ESE guidelines recommend clinical and radiographic follow-up for at least one year after endodontic treatment, with the patient's radiation dose as low as possible to achieve the desired level of diagnosis. The use of CBCT with ethical approval is justified in the clinical use of small CBCT scans for research purposes: to evaluate treatment with new protocols, disinfection techniques, which will provide a more objective treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •teeth tender to percussion, palpation
- •teeth that have a sinus tract and swelling
- •a chronic periapical lesion greater than 5 mm in diameter based on the initial X-ray
- •previous endodontic treatment and root canal filling that is inadequate according to clinical criteria (filling, overfilling, non-homogeneous root canal filling, unfilled root canals)
排除标准
- •immunocompromised patients
- •pregnant women
- •teeth with a periodontal pocket depth greater than 3 mm
- •teeth with signs and symptoms of vertical fracture
- •teeth that cannot be restored or prosthetically provided after endodontic treatment
- •use of antibiotic therapy within the last month
- •diagnosis of acute apical abscess
研究组 & 干预措施
SSP modality of Er:YAG laser activated irrigation
In group 1, irrigant in the final irrigation protocol will be activated by a radial laser attachment (diameter: 400 µm) of an Er:YAG laser (Fotona, Ljubljana, Slovenia). The laser settings will be: SSP mode, pulse energy 20 mJ, frequency 15 Hz, pulse duration 50 µs according to the factory settings of the Er:YAG laser for laser-activated disinfection and according to the endodontic space disinfection protocol (23).
干预措施: Laser activated irrigation (Device)
Sound-activated irrigation (Smart Lite Pro EndoActivator, DentsplySirona)
In group 2, each irrigant in the final irrigation protocol will be activated by the polymer tip of the sonic irrigation device. The tip will be placed 2 mm from the working length of the canal. The activation time will be 30 s for NaOCL, 60 s for EDTA and 30 s for NaOCl.
干预措施: Sound-activated irrigation (Device)
结局指标
主要结局
Postoperative pain
时间窗: From day 1 after treatment to 7 days postoperatively
Following single-visit revision performed with different irrigation activation techniques, occurance, duration and intensity of postoperative pain will be assessed via a questionnaire. A score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity.
Radiographic healing of periapical lesions
时间窗: At the 12-month
The healing analysis of the lesion will be performed by volumetric assessment using the ITK-SNAP software. Calculation and volumetric assessment in mm3 will be performed with ITK-SNAP with additional shaping, manual adjustment and transfer. In multi-rooted teeth, the defect will be displayed as the sum of individual periapical processes. All processes smaller than twice the thickness of the periodontal ligament will be counted as 0 mm3, or complete healing.
次要结局
- Microbiological efficiency(At the baseline)
研究者
Domagoj Kunčić
Dr. Domagoj Kunčić
University of Zagreb
