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

NCT ID: NCT07256691

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asymptomatic Apical Periodontitis

Keywords

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Bioceramic sealer Resin-based sealer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Resin-based sealer obturation technique

Intervention Type 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 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).

Group Type EXPERIMENTAL

Bioceramic sealer obturation

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatima Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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SHEHRYAR KHAN

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fatima Memorial Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Shehryar Khan, Bachelor Of Dental SURGERY

Role: CONTACT

Phone: +92 336 9892535

Email: [email protected]

Facility Contacts

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SHEHRYAR KHAN SHEHRYAR KHAN, BACHELOR OF DENTAL SURGERY

Role: primary

Other Identifiers

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FMH-13/06/2025-IRB-1673

Identifier Type: -

Identifier Source: org_study_id