Pain Reduction After One-visit Root Canal Treatment Using Two Cold Irrigating Protocols in Teeth With Vital Pulps.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
研究概览
简要总结
The goal of this clinical research was to relate the incidence of post-endodontic pain after one-visit root canal treatment using two cold protocols of irrigation. Methodology: All 240 patients had upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons detected with only vital pulps (symptomatic or asymptomatic condition). Of the sample of 240 teeth, were selected to different manner to irrigate. Reciproc instruments were used with a micro motor (VDW, Munich Germany). Final irrigation with cold (6oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
详细描述
RCT was done in one-visit. Topical anesthetic (Anestesia Topica, Astra Mexico) was applied before infiltration. Patients received 2 carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In circumstances in which additional anesthesia was required, intra-ligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the solution was injected by slow and gradual local infiltration. For the lower teeth, 1 of the carpules was used for an inferior alveolar nerve block and the other 1 for a gentle labial infiltration near the tooth to be treated.
Rubber dam was placed and the tooth was clean with 5.25% NaOCl. Preparation of the access cavity was achieved using sterile # 331 bur (Dentsply Int, York, PA), with high-speed and refrigeration. 5.25% NaOCl was employed to disinfect the coronal access. The canals were cautiously probed with #10 K-type file (Flex-R files, Moyco/Union Broach, York PA, USA).
17% EDTA (Roth International, Chicago, IL) irrigant was administered at the entrance of the canals. Working length was established with a #15 k-file and the Root ZX electronic apex locator (J Morita, Irvine CA, USA), and confirmed radiographically (Schick Technologies, NY, USA). Cervical and middle thirds of the canal was flared with a K3XF 25/10 rotary instrument (Kerr Endo, Orange County, CA) at 500 rpm. The root canal was flushed with 3 mL 5.25% sodium hypochlorite (NaOCl). A glide path to the WL was then established.
Preparations of the canals were completed with an electric motor (VDW Silver Motor, VDW, Munich Germany). Torque and rotation were predetermined for each reciproc instrument, and were used in continuous reciprocating mode.
Dentinal remains were removed from the instrument with a sterile gauze, immediately to the instrument change after two-three pull in-and-pull out (pecking) movements (Reciproc) following the manufacturers' recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Certified endodontist (3) trained in the procedures, devices, and irrigating systems investigated took part in the research. All experts tracked a pre-established procedure for Reciproc instrument systems and cryotherapy.
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
- 是
入选标准
- •absence of radiographic sign of apical pathosis and a diagnosis of irreversible pulpitis (IP) and vital pulp established by affirmative response to hot and cold examinations.
- •Thermal pulp examination was achieved by the corresponding author, and radiographic analysis was established by 3 certified endodontists.
- •Clinical requirements were established on the next conditions: 1) The purposes and necessities of the research were spontaneously accepted. 2) Clinical Management was pointed to patients in physical and mental well- being. 3) All teeth had vital pulps and absence of apical periodontitis. 4) Positive thermal stimulation with EndoIce (Hygenic Corp, Akron, OH). 5) Teeth with enough coronal structure for rubber dam isolation. 6) No root canal therapy done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started.
排除标准
- •the necessity for retreatment
- •pregnancy
- •impossibility to obtain patient's approval
- •patients who didn't complete inclusion necessities for the research
- •a history of medication for chronic pain or those compromising the immune response
- •patients younger than 18 years and the existence of mishaps or difficulties during RCT (calcified canals, impracticality of achieving Apical patency).
- •Root fractures
研究组 & 干预措施
Group A. Cold Protocol with 6 oC
Use of 20 mL cold (6 oC) sterile saline solution.
After the clinical procedure cryotherapy was applied. 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
干预措施: For the Group A. Applied Cryotherapy at 6 oC (Procedure)
Group B. Cold Protocol with 2.5 oC
Use of 20 mL cold (2.5 oC) sterile saline solution
After the procedure cryotherapy was applied. 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
干预措施: For the Group B. Applied Cryotherapy at 2.5 oC (Procedure)
CG. Room temperature Protocol
Use of 20 mL (at room temperature) sterile saline solution
The group will receive irrigant at room temperature. 5mL of 17% EDTA and 20 mL of sterile saline usingmetallic micro-cannula included in the Endo Vac System for five minutes.
干预措施: Control Group (CG). Applied irrigant at room temperature (Procedure)
结局指标
主要结局
Evaluate the post-endodontic pain after one-visit after the root canal treatment with reciprocating NiTi system.
时间窗: 24 hours to 72 hours
Pain was evaluated after 24, 48 and 72 hrs after instrumentation with reciproc NiTi instruments, the 80 canals were flushed with cold irrigants (6 and 2.5 oC). According to the VAS table provided to the participants
次要结局
- Evaluate the Use of intracanal cryotherapy on post-endodontic pain after single-visit RC.(24 hours to 72 hours)
研究者
Jorge Paredes Vieyra
DDS, MsC, PhD
Universidad Autonoma de Baja California