Evaluation of the Effects of Root Canal Sealers on Postoperative Pain and Radiographic Healing in Patients With Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)
研究概览
简要总结
This clinical study evaluated whether different root canal sealers influence postoperative pain and early periapical healing in patients with apical periodontitis. A total of 72 adult patients with single-rooted teeth diagnosed with chronic apical periodontitis received standardized root canal treatment and were randomly assigned to one of three commonly used sealers: AH Plus, MTA Fillapex, or Sealapex.
Postoperative pain was recorded using a verbal pain rating scale immediately after treatment and at 24 and 72 hours. Periapical healing was assessed at baseline and after six months using periapical radiographs and cone-beam computed tomography (CBCT).
The purpose of this study was to determine whether the type of root canal sealer affects patient comfort after treatment and the early healing of periapical tissues. Understanding these outcomes may help clinicians choose appropriate materials and better inform patients about expected pain and healing after root canal therapy.
详细描述
This study was designed as a single-center, randomized, controlled clinical trial to compare the effects of three different root canal sealers on postoperative pain and radiographic periapical healing in patients with apical periodontitis.
A total of 72 patients aged 18-65 years with single-rooted anterior or premolar teeth diagnosed with chronic apical periodontitis were enrolled. Patients with systemic diseases beyond ASA I-II status, previous endodontic treatment, root fractures, severe canal curvature, open apices, or recent use of antibiotics or analgesics were excluded to ensure standardization.
After obtaining informed consent, participants were randomly allocated into three equal groups according to the sealer used for root canal obturation: Sealapex (calcium hydroxide-based sealer), MTA Fillapex (MTA-containing salicylate resin-based sealer), or AH Plus (epoxy resin-based sealer). All root canal treatments were performed in a single visit under rubber dam isolation by the same experienced endodontist to eliminate inter-operator variability.
Root canals were prepared using a standardized nickel-titanium instrumentation system and irrigated with sodium hypochlorite and EDTA according to a uniform protocol. Obturation was completed using the lateral condensation technique with gutta-percha and the assigned sealer. Permanent composite restorations were placed after obturation.
Postoperative pain was assessed using the Verbal Rating Scale (VRS) immediately after treatment and at 24 and 72 hours. Patients were instructed not to use analgesics unless severe pain occurred.
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
- Single (Outcomes Assessor)
盲法说明
Radiographic and CBCT images were anonymized and evaluated by independent examiners who were blinded to the intervention groups.
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
- 否
入选标准
- •Adults aged 18 to 65 years
- •Patients diagnosed with apical periodontitis
- •Presence of a single-rooted anterior or premolar tooth with a radiographically visible periapical lesion
- •Systemically healthy individuals classified as ASA I or ASA II
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Teeth with root fractures, external resorption, or open apices
- •Calcified canals or severely curved root canals (>30°)
- •Periodontal pocket depth greater than 3 mm
- •Pregnancy
- •Use of antibiotics or analgesics within the previous 7 days
- •History of previous endodontic treatment or retreatment in the study tooth
- •Presence of systemic conditions that could affect healing
研究组 & 干预措施
Sealapex Group
Participants received standardized single-visit root canal treatment using Sealapex as the root canal sealer during obturation.
干预措施: Root Canal Treatment With Sealapex (Procedure)
MTA Fillapex Group
Participants received standardized single-visit root canal treatment using MTA Fillapex as the root canal sealer during obturation.
干预措施: Root Canal Treatment With MTA Fillapex (Procedure)
AH Plus Group
Participants received standardized single-visit root canal treatment using AH Plus as the root canal sealer during obturation.
干预措施: Root Canal Treatment With AH Plus (Procedure)
结局指标
主要结局
Postoperative Pain Intensity Assessed by Verbal Rating Scale (VRS)
时间窗: Immediately after treatment, 24 hours, and 72 hours after root canal treatment
Postoperative pain intensity was evaluated using the Verbal Rating Scale (VRS). Patients were asked to verbally rate their pain according to the following categories: 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain.
次要结局
- Periapical Healing Assessed by Cone-Beam Computed Tomography (CBCT)(Baseline and 6 months after treatment)
- Periapical Healing Assessed by Periapical Index (PAI)(Baseline and 6 months after treatment)
研究者
Aliye Kamalak
Associate Professor
Kahramanmaras Sutcu Imam University