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NCT Number: NCT07256691

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatima Memorial Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

SHEHRYAR KHAN SHEHRYAR KHAN, BACHELOR OF DENTAL SURGERY

CONTACT

[email protected]

+923369892535

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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).

Primary outcomes

  1. Postoperative pain

    Time frame: 4, 24, and 48 hours after root canal obturation.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shehryar Khan, Bachelor Of Dental SURGERY

CONTACT

[email protected]

+92 336 9892535

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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