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

NCT07256691 | Recruiting

• 1 other identifier: FMH-13/06/2025-IRB-1673
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asymptomatic Apical Periodontitis

Keywords

Bioceramic sealer; Resin-based sealer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Bioceramic Sealer Group

EXPERIMENTAL

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

Resin-Based Sealer Group

EXPERIMENTAL

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

Interventions

Resin-based sealer obturation technique PROCEDURE

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.

Resin-Based Sealer Group

Bioceramic sealer obturation PROCEDURE

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).

Bioceramic Sealer Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fatima Memorial Hospital: lead

Study Sites (1)

Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Central Study Contacts

Shehryar Khan, Bachelor Of Dental SURGERY

CONTACT

+92 336 9892535; shehryar_jadun@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study where both the participant and the care provider (dentist performing the root canal treatment) are blinded to the type of sealer used. Additionally, the outcome assessor (person recording postoperative pain levels) is also blinded to the sealer material used. The sealers are coded and labeled in a way that prevents both the provider and participant from identifying which material is being used during the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)