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临床试验/NCT05718596
NCT05718596已完成不适用

The Antimicrobial Efficacy of Sweeps Laser Compared to Ultrasonically Activated Irrigation and Needle Irrigation in Posterior Teeth With Apical Periodontitis: A Clinical Study

Seyda Ersahan, DDS, PhD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
the sequence analysis of 16S rRNA genes by the Sanger sequencing

研究概览

简要总结

Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different irrigation activation methods [ Sweeps laser and PUI group ] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. 30 patients with apical periodontitis (one tooth each) were randomly allocated into two groups according to the used (n=15, for each): the Sweeps laser group (A) or the vdw ultra group (B). Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.

详细描述

Eligibility criteria The study population consisted of 30 patients (aged 19-66 years) presenting to the endodontic clinic at Istanbul Medipol University Dental School, for nonsurgical endodontic treatment of teeth with apical periodontitis lesions. 30 teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions were included in this study. BT lab branded ELISA Kits (Shangai, China) were used to measure IL-1Beta levels. Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm. Teeth with apical periodontitis had required treatment. Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm. Exclusion criteria were also applied, as follows: teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.

Root canal treatment procedures and sampling Rubber dam and an aseptic technique were used throughout the endodontic retreatment. After plaque removal and rubber dam isolation, the operative field was cleaned with 3% hydrogen peroxide and disinfected with 2.5% NaOCl solution. Then, all coronal restorations, posts and carious defects were removed and access preparation was completed when the root canal filling was properly exposed. Afterwards, the tooth (including the pulp chamber), clamp, and adjacent rubber dam were once again disinfected with 2.5% NaOCl, followed by inactivation with 10% sodium thiosulfate in order to avoid interference with bacteriological sampling. Sterility control samples (SR1) were taken from the tooth surface with a sterile Omni Swab (Whatman FTA, Sigma-Aldrich) with an ejectable head. Paper points were transferred to cryotubes containing phosphate buffered saline (PBS) solution stored at -20°C. In each case, a single root canal was sampled in order to confine the microbial evaluation to a single ecological environment. In multirooted teeth, the root with the periapical lesion was selected. If there were periapical lesions in all roots, the wider canal was selected.

The working length (WL) was established 1-mm short of the apical foramen with an apex locator (Raypex6; VDW GmbH, Munich, Germany), and then periapical radiographs were taken to ensure that all filling material was removed. Irrigation with sterile saline solution was performed in order to remove any remaining materials and to moisten the canal prior to sample collection. Next, the canal was left filled with saline, and a small hand instrument was placed at the WL and used to gently file the canal walls. An initial microbiologic sample (S1) was taken from the root canal with sterile paper points consecutively placed at the WL. Three sterile paper points were inserted into the root canal for sampling. Each paper point was left in the canal for about 1 minute. Both the paper points and the endodontic hand instrument, without the handle, were transferred to cryotubes containing 300 μl of PBS solution stored at -20°C. The samples were transferred to genetic analysis laboratory for further analysis in cold chain.

Root canals were prepared by using the ProTaper Next; Dentsply-Sirona, Ballaigues, İsviçre files and irrigated with 2.5% NaOCl. The canals were apically enlarged to size 35 (AS35) at the working length. Between each instrument change, the root canal was irrigated with 5 ml of 2.5% NaOCl solution by using 30-gauge side-vented needle, which was placed 1 to 2 mm short of working length. Hence, a total of 30 mL of the irrigating solution was used. After instrumentation was completed, the smear layer was removed with 2 mL 17% EDTA, which was left in the canal for 3 min, followed by 2.5% NaOCl. The root canal was dried with sterile paper points and flushed with 2 ml of 10% sodium thiosulfate for 1 min to inactivate the NaOCl solution. Next, a sample (S2) was taken from the canals as described for S1. Following this, the NaOCl was agitated/activated as described below.

Sweeps group: The SWEEPS fiber tip (25 µs ultra-short dual pulse mode-Auto SWEEPS mode) was inserted into the Er:YAG laser source (2,940 nm, 20 mJ per pulse, 15 Hz, 0.3 W power, and 50 µs pulse frequency). The SWEEPS tip placed in the access cavity was kept in a stable position, and activation was performed in the SWEEPS mode using the same method with the same amount of irrigation solutions described for the PIPS group.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions.
  • Teeth with lesion apical periodontitis
  • Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
  • The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
  • Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm.

排除标准

  • teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth >4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.

结局指标

主要结局

the sequence analysis of 16S rRNA genes by the Sanger sequencing

时间窗: hrough study completion, an average of 1 year

次要结局

未报告次要终点

研究者

发起方
Seyda Ersahan, DDS, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seyda Ersahan, DDS, PhD

The Antimicrobial Efficacy of Sweeps Laser Compared to Ultrasonically Activated Irrigation and Needle Irrigation in Posterior Teeth With Apical Periodontitis: A Clinical Study

Istanbul Medipol University Hospital

研究点 (1)

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