Reduction of Post-endodontic Pain After Single-visit RCT Using Three Irrigating Regimens.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs.
研究概览
简要总结
The goal of this research was to relate the occurrence of post-endodontic pain after single-visit RCT using there irrigating regime. Methodology: All 216 patients had upper or lower molar, premolar or anterior teeth selected for conventional RCT for prosthetic reasons detected with only vital pulps. Of the sample of 216 teeth, were selected to just one method for instrumentation and different manner to irrigate. All instruments were used with a micro motor (VDW, Munich Germany). Reciproc instruments. Final irrigation with cold (8oC, 2.5 oC and room temperature 17% EDTA and saline solution served as a lubricants.
详细描述
Two hundred and sixteen of 245 patients (119 women and 97 men) aged 18-65 years were referred and incorporated in this research while 29 were excluded as not meeting the inclusion criteria. All patients presented with a vital upper or lower molar, premolar or anterior teeth selected for conventional root canal treatment for prosthetic reasons.
Patients rejecting to join the study or rejecting, single-visit root canal treatment, consuming analgesics or NSAIDs were excluded too. All participants were informed on the goals, risks and strategy of the study, and written informed consent permissions were gained previous their enrollment.
Random Selection of instrumentation groups. An investigator who had not contributed in the study made the randomization arrangement using a computer random table generator (www.random.org). Each patient receive a consecutive number. A total of 216 patients met the inclusion requirements and were incorporated in the study. Of the sample of 216 teeth, 72 were randomly assigned to the one of the 3 irrigating methods. Treatment was performed by 3 experienced endodontists; each prepared 72 teeth, 24 per method.
Treatment Protocol All patients were anesthetized with two carpules of articaine 2% with epinephrine 1:200,000 (Septodont, Saint-Maur des-Fosses, France). In cases in which supplemental anesthesia was needed, intraligamental anesthesia (2 mL articaine 2%) was administered. For the upper teeth, the 2 carpules were administered by gradual infiltration in the buccal vestibule. For the lower teeth, 1.5 of the carpules was used for an inferior alveolar nerve block and the other 1.5 for a gentle buccal infiltration around the tooth to be treated.
After absolute isolation using rubber dam, the tooth was disinfected with 5.25% NaOCl. Preparation of the access cavity was performed using # 331 bur (Dentsply International, York, PA), with high-speed and water cooling. 5.25% NaOCl was used to clean the coronal cavity. The root canals were carefully probed with #10 K-type hand files (Flex-R files, Moyco/Union Broach, York PA, USA).
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 endodontists trained in the procedures, devices, and 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 periodontitis and a diagnosis of irreversible pulpitis (IP) 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 RCT done before the research. 7) No painkillers or antibiotics used 7 days' prior the clinical events started
排除标准
- •Exclusion parameters were:
- •the necessity for retreatment
- •gravidity
- •impossibility to obtain patient's approval
- •patients who didn't complete inclusion necessities
- •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 AP in any can
研究组 & 干预措施
Group A
The R25 (size 25/ .08) instrument was used in thin and curved root canals, and R40 files (40/ .06) were used in wide root canals. Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length.
After the procedure cryotherapy will be applied as follows:
Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes
干预措施: Applied saline solution at 8oC (Cryotherapy ) (Procedure)
Group B
Canals were prepared as in group A, Patients assigned to this group receive (application of criotherapy)
A final irrigation will be applied with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes. was applied. as follows:
Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes
干预措施: Applied saline solution at 2.5 oC (Cryotherapy group) (Procedure)
Control Group (CG)
The R25 (size 25/ .08) instrument was used in thin and curved root canals, and R40 files (40/ .06) were used in wide root canals. Three in-and-out pecking motions were used with an amplitude of not more than 3 mm until reaching the estimated working length. Reciproc instruments were used in one tooth only (single use).
The group will receive the irrigant solution at room temperature. as follows:
they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
干预措施: Applied saline solution at room temperature (No cryotherapy) (Procedure)
结局指标
主要结局
Evaluate the post-endodontic pain after 24 hrs,48 and 72 hrs.
时间窗: 24 hours to 72 hours
Post-endodontic pain was evaluated after root canal treatment in order to identify in 216 patients: none, mild or severe pain.
次要结局
- Evaluate the effect of intracanal cryotherapy on post-endodontic pain after root canal treatment.(24 hours to 72 hours)
研究者
Jorge Paredes Vieyra
Chairman of Post graduate Programs in Dentistry
Universidad Autonoma de Baja California