Postoperative Pain After Root Canal Obturation Using Bioceramic and Calcium Hydroxide Sealers (BCvsCaOH)

HITEC-Institute of Medical Sciences

Status: Enrolling

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Procedure: CeraSeal Bioceramic Sealer; Procedure: Sealapex Calcium Hydroxide Sealer

Study type: Interventional

Funder types: Other

Identifiers

NCT07410780

HITEC-IMS-ENDO-RCT-2025

Details and patient eligibility

About

This study is designed to find out how different root canal sealers affect pain after root canal treatment. We are comparing two types of dental sealers: bioceramic sealer and calcium hydroxide sealer.

Participants who need root canal treatment will receive one of these sealers as part of their standard dental care. After the procedure, they will be asked to report any pain they experience for a few days.

The information from this study will help dentists choose sealers that may reduce post-treatment pain and improve patient comfort after root canal therapy.

Full description

This randomized controlled clinical trial is designed to evaluate postoperative pain following root canal obturation using two different endodontic sealers: a bioceramic (calcium silicate-based) sealer and a calcium hydroxide-based sealer. Postoperative pain is a common complication of root canal therapy and may influence patient satisfaction as well as perceived treatment success. The physical and chemical properties of root canal sealers may contribute to postoperative discomfort through their interaction with periapical tissues.

The study will be conducted at the Department of Operative Dentistry, HITEC-IMS Dental College over a period of six months to 1 year following institutional approval. A total sample size of 50 participants will be enrolled and randomly allocated into two parallel groups using a lottery method, with 25 participants assigned to each group. A single-blind design will be maintained, in which participants will be unaware of the sealer used.

All clinical procedures will be performed in a single visit by the same operator to minimize procedural variability. Following diagnosis and confirmation of pulp vitality, standard endodontic treatment will be carried out under local anesthesia and rubber dam isolation. Canal preparation will be performed using hand and nickel-titanium rotary instruments. Irrigation will be carried out using sodium hypochlorite and EDTA solutions, followed by saline as the final rinse. Canals will be dried using sterile paper points.

Obturation will be performed using a single-cone technique with a matching-taper gutta-percha cone coated with the assigned sealer. Participants in the experimental groups will receive either a bioceramic sealer or a calcium hydroxide-based sealer. Access cavities will be restored with glass ionomer cement, and occlusal reduction will be performed to minimize postoperative discomfort due to occlusal trauma. No postoperative medications will be prescribed.

Postoperative pain will be evaluated using a Visual Analog Scale (VAS) at predefined time intervals following obturation. Analgesic intake, if any, will also be recorded to support accurate interpretation of pain outcomes.

Collected data will be entered into a spreadsheet and analyzed using statistical software. Comparative analysis of postoperative pain scores between the two groups at different time intervals will be performed using appropriate statistical tests.

Participant confidentiality will be maintained throughout the study. All collected data will be anonymized and used exclusively for research purposes.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-40 years
• Single-rooted permanent teeth
• Teeth diagnosed with symptomatic irreversible pulpitis
• Normal periapical condition on radiographic examination or periodontal ligament (PDL) space widening
• Restorable teeth

Exclusion criteria

• Patients with systemic conditions that could alter the course of treatment
• Teeth with immature root development
• Teeth with necrotic pulp
• Teeth exhibiting root resorption
• Teeth with calcified root canals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Bioceramic Sealer Group

Experimental group

Description:

Participants in this group will receive root canal obturation using bioceramic (calcium silicate-based) sealer (CeraSeal) following standard endodontic procedures. After proper anesthesia and rubber dam isolation, the canals will be prepared, irrigated, and dried. A single-cone obturation technique will be used to place the sealer and gutta-percha. The cavities will be sealed with glass ionomer cement, and patients will record postoperative pain using the Visual Analog Scale (VAS) at 12, 24, 48, and 72 hours.

Treatment:

Procedure: CeraSeal Bioceramic Sealer

Calcium Hydroxide Sealer

Experimental group

Description:

Participants in this group will receive root canal obturation using calcium hydroxide-based sealer (Sealapex) following the same standard endodontic procedures as Arm 1. Postoperative pain will be measured using the VAS at 12, 24, 48, and 72 hours.

Treatment:

Procedure: Sealapex Calcium Hydroxide Sealer