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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asymptomatic Apical Periodontitis
• Intervention / Treatment: Procedure: Bioceramic sealer obturation; Procedure: Resin-based sealer obturation technique

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shehryar Khan, Bachelor Of Dental SURGERY; Phone Number: +92 336 9892535; Email: shehryar_jadun@yahoo.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • Fatima Memorial Hospital
      • Contact: SHEHRYAR KHAN SHEHRYAR KHAN, BACHELOR OF DENTAL SURGERY; Phone Number: +923369892535; Email: shehryar_jadun@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioceramic Sealer Group; 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).	Procedure: 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 sealed with a temporary or permanent restoration. Postoperative pain will be assessed at 4, 24, and 48 hours using the Numeric Pain Rating Scale (NPRS).
Experimental: Resin-Based Sealer Group; 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).	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Pain intensity will be measured using the Numeric Pain Rating Scale (0-10). The highest score among the three time points will determine outcome. Scores 0-7 are considered successful; 8-10 indicate failure.	4, 24, and 48 hours after root canal obturation.

Collaborators and Investigators

• Sponsor: Fatima Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Bioceramic sealer; Resin-based sealer
• Other Study ID Numbers: FMH-13/06/2025-IRB-1673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD shared will include demographic information, clinical findings, pain scores, and treatment details for each patient.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No