Influence of Sealer Composition on Post-Endodontic Pain

NCT07767084 | Recruiting DMC

• 1 other identifier: Post-Endodontic Pain
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life. The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.

Conditions

Post Endodontic Pain

Outcome Measures

Primary Outcomes (1)

• Post Endodontic Pain Intensity

  Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups

  7 days

Study Arms (3)

Group A (Calcium Hydroxide-based Sealer: Sealapex):

ACTIVE COMPARATOR

About 22 cases will be subjected to: 1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement. 2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated. 3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique. 4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument. 5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline.

Procedure: Calcium Hydroxide-based Sealer

Group B (Bioceramic Sealer: Well-Root):

ACTIVE COMPARATOR

About 22 cases will be subjected to: 1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer. 2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion. 3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation. 4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier. 5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline.

Procedure: Calcium Hydroxide-based Sealer

Group C (Resin-based Sealer: ADSEAL):

ACTIVE COMPARATOR

About 22 cases will be subjected to: 1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application. 2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length. 3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation. 4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation. 5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer.

Procedure: Calcium Hydroxide-based Sealer

Interventions

Calcium Hydroxide-based Sealer PROCEDURE

to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.

Also known as: Bioceramic Sealer and Resin-based Sealer

Group A (Calcium Hydroxide-based Sealer: Sealapex):; Group B (Bioceramic Sealer: Well-Root):; Group C (Resin-based Sealer: ADSEAL):

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requiring primary root canal treatment.
• Patients with acute irreversible pulpitis.
• Patients in good general health

You may not qualify if:

• Patients with systemic diseases affecting pain perception or healing.
• Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
• Pregnant or lactating women.
• Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Endodontics Department Faculty of Dentistry

Minya, Egypt

RECRUITING

Study Officials

• Dalia Ali Ahmed Moukarab, Professor

  Professor and Head of the Endodontics Department, Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

Nourhan Rabie Ahmed Ahmed, B.D.S

CONTACT

+201148809567; nourhan.rabie93@gmail.com

Dalia Ali Ahmed Moukarab, Professor

CONTACT

+201068121523; dalia.mokarab@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at department of Endodontics, Faculty of Dentistry

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 14, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-04

Locations

EG (1)