Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Resin-based sealer obturation technique, Bioceramic sealer obturation.
- Who it may be relevant to
- Registry conditions: Asymptomatic Apical Periodontitis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Calcium-Based Bioceramic Sealer and Resin-Based Sealer on Postoperative Pain in Adults With Asymptomatic Apical Periodontitis
Overview
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
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.
Interventions
- 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. - 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 seale
Primary outcome measures
- Postoperative pain [Time frame: 4, 24, and 48 hours after root canal obturation.]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Fatima Memorial Hospital — Lahore
Identifiers
NCT: NCT07256691 · FMH-13/06/2025-IRB-1673