Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment in Molars With Pulpal Disease. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- postoperative pain intensity using numerical rating scale
研究概览
简要总结
The aim of this clinical study is to evaluate the influence of apical patency concept implementation upon postoperative pain following root canal treatment in a single visit approach in molars with pulpal disease.
详细描述
All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.
Canals will be scouted using manual patency file in a watch winding maneuver and then coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device. Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #20/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). In Gp A, apical patency will be maintained till obturation using electronic apex locator confirmed radiographically while in Gp B apical patency will not be maintained. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient age between 18-60 years old.
- •Both males and females will be included.
- •All patients are in a good health without systemic condition.
- •The offending tooth is a molar.
- •The offending molar is indicated for root canal treatment.
- •One molar for every patient.
- •All patients will sign an informed consent.
排除标准
- •The offending tooth has previous attempt of pulp therapy or root canal treatment.
- •The patient showing any clinical or radiographic evidence of periapical pathosis.
- •Patients received analgesics or systemic antibiotic prior to treatment.
- •Immunocompromised patients.
- •Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
- •History of cancer with radio or chemotherapy.
- •Offending molar with mobility score ≥
- •Offending molar with pocket depth ≥6mm.
- •Immature molars.
- •Nonodontogenic pain.
- •Patients with more than one tooth requiring endodontic intervention.
结局指标
主要结局
postoperative pain intensity using numerical rating scale
时间窗: after 48 hours after root canal treatment
postoperative pain after root canal treatment
次要结局
未报告次要终点
研究者
Heba Elasfouri
Associate professor
Cairo University