Comparison of Calcium Hydroxide and Diclofenac Sodium as Intracanal Medicaments on Periapical Healing: A Fractal Analysis Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Periapical Lesion Healing
研究概览
简要总结
This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.
详细描述
Removal of Previous Root Canal Filling All stages of the root canal procedure are to be performed by a single endodontist with seven years of clinical experience. Local anesthesia is to be achieved with supraperiosteal infiltration of 4% articaine containing 1:100,000 epinephrine (Ultracain D-S; Sanofi, Paris, France). The tooth is to be isolated with a rubber dam, and canal access is to be achieved through a conventional access cavity. The filling material in the access cavity is to be removed using a water-cooled diamond fissure bur.
Root filling material is to be removed using ProTaper Universal Retreatment files operated at 500 rpm. D1 (30/0.09), D2 (25/0.08), and D3 (20/0.07) files are to be used in the coronal, middle, and apical thirds, respectively. Apical patency is to be verified, and the master apical file (MAF) is to be used up to the working length, which is to be determined when the electronic apex locator (Morita Root ZX, Tokyo, Japan) displays "0.0" and confirmed radiographically.
The MAF is to be selected according to the canal volume, and canal preparation is to be completed. Retreatment is to be considered complete when no residual filling material is observed radiographically.
Medication Application and Randomization Patients are to be randomly assigned into two groups (Ca(OH)₂ and DCS) using block randomization technique (allocation ratio 1:1) via www.randomizer.org. The intracanal medicaments are to be prepared by an independent clinician not involved in the study. Both the operator and the patient are to be blinded to the type of medicament used. The medicaments will have similar appearance, color, and consistency to maintain blinding.
Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.
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)
盲法说明
Patients are to be randomly assigned into two groups (Ca(OH)₂ and DCS) using a four-block randomization technique (allocation ratio 1:1) via www.randomizer.org. The intracanal medicaments are to be prepared by an independent clinician not involved in the study. Both the operator and the patient are to be blinded to the type of medicament used. The medicaments will have similar appearance, color, and consistency to maintain blinding.
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
- •The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥
- •Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality.
- •The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment.
排除标准
- •Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study.
- •Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.
研究组 & 干预措施
Diclofenac sodium
1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water.
After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point.
干预措施: Diclofenac sodium (Procedure)
Calcium hydroxide
1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point.
干预措施: Diclofenac sodium (Procedure)
结局指标
主要结局
Periapical Lesion Healing
时间窗: 1 year
The primary outcome is to be the reduction in periapical lesion volume, which will be assessed by fractal analysis of periapical radiographs obtained before treatment and at the 12-month follow-up.
次要结局
未报告次要终点
研究者
Merve Sari
Assistant Professor
Mustafa Kemal University