Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain

Официальное название

Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain in Adults With Asymptomatic Apical Periodontitis

Обзор

This study aims to compare the effect of calcium-based bioceramic sealer and resin-based sealer on postoperative pain in adult patients with asymptomatic apical periodontitis undergoing root canal treatment. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not experience pain. A total of 60 patients will be randomly assigned to receive root canal treatment with either the bioceramic sealer (Group A) or the resin-based sealer (Group B). Pain after treatment will be measured using a 0-10 Numeric Pain Rating Scale at 4, 24, and 48 hours post-treatment. The highest pain score reported will determine whether the treatment is considered a success (no or mild/moderate pain) or failure (severe pain). The results of this study will provide evidence on which sealer is associated with less postoperative pain, helping clinicians make informed decisions about root canal filling materials.

Подробное описание

This randomized controlled clinical trial aims to compare calcium-based bioceramic sealer and resin-based sealer in root canal treatment for adult patients with asymptomatic apical periodontitis. Asymptomatic apical periodontitis is a condition where the tissue around the tip of the tooth root is inflamed or shows a lesion on X-ray, but the patient does not feel pain.

A total of 60 patients aged 18-55 years will be recruited at the Department of Operative Dentistry, Fatima Memorial Hospital, Lahore. Eligible patients will have non-vital teeth with fully formed roots and periapical lesions classified as PAI scores 2-4. Patients with systemic diseases, periodontally compromised teeth, or complications during treatment will be excluded.

Patients will be randomly assigned to two groups: Group A will receive root canal obturation using bioceramic sealer, and Group B will receive resin-based sealer. The treatment procedure involves standard root canal cleaning and shaping, irrigation, and obturation using a single-cone technique with Gutta-percha.

Postoperative pain will be assessed using a Numeric Pain Rating Scale (0-10) at 4, 24, and 48 hours after obturation. The highest pain score reported across these time points will determine the outcome. Pain levels will be classified as: None (0), Mild (1-3), Moderate (4-7), or Severe (8-10). Patients with severe pain (8-10) will be considered treatment failures, while all others will be considered treatment successes.

Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables, and Chi-square tests will compare postoperative pain between groups. The study aims to provide evidence on which sealer results in less postoperative pain, supporting better clinical decision-making in endodontics.

Вмешательства

• Процедура Resin-based sealer obturation technique
  Root canal obturation using resin based sealer with single cone GP technique. Canals prepared and irrigated as above. Pain recorded at 4, 24, and 48 hours post-obturation using NPRS.
• Процедура Bioceramic sealer obturation
  Participants in this group will undergo root canal obturation using a calcium silicate based bioceramic sealer with a single-cone gutta percha technique. After standard canal preparation and irrigation with 2.5% sodium hypochlorite, the canals will be dried with paper points. The bioceramic sealer will be applied using a lentulospiral or directly coated on the master gutta-percha cone. A matched-taper gutta-percha cone will then be inserted to full working length. The canal orifice will be seale

Первичные конечные точки

• Postoperative pain [Срок оценки: 4, 24, and 48 hours after root canal obturation.]

Критерии участия

Inclusion Criteria:Age 18-55 years.

• Both genders.
• Teeth diagnosed with asymptomatic apical periodontitis.
• Teeth are asymptomatic (no pain on percussion or palpation).
• Non-vital pulp (no response on Electric Pulp Testing).
• Teeth with fully formed apices.
• Teeth with Periapical Index (PAI) scores 2-4 on radiographs.

Критерии исключения

• Medically compromised patients (e.g., those with immunosuppressive or systemic diseases, or on medications that may affect healing).
• Patients who refuse to participate or are unable to communicate their symptoms (e.g., due to psychological disorders).
• Teeth where full working length cannot be reached.
• Periodontally compromised teeth (probing depth >4 mm).
• Complications during treatment (e.g., separation of a file, ledging).
• Overfilling (filling beyond the radiographic apex) or short filling (>2 mm from the radiographic apex).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Fatima Memorial Hospital — Lahore

Идентификаторы

NCT: NCT07256691 · FMH-13/06/2025-IRB-1673

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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