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

Fatima Memorial Hospital

Status: Enrolling

Conditions: Asymptomatic Apical Periodontitis

Treatments: Procedure: Resin-based sealer obturation technique; Procedure: Bioceramic sealer obturation

Study type: Interventional

Funder types: Other

Identifiers

NCT07256691

FMH-13/06/2025-IRB-1673

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Bioceramic Sealer Group

Experimental group

Description:

Patients in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS).

Treatment:

Procedure: Bioceramic sealer obturation

Resin-Based Sealer Group

Experimental group

Description:

Patients in this group will receive root canal obturation using resin-based sealer with gutta-percha. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS).

Treatment:

Procedure: Resin-based sealer obturation technique