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NCT Number: NCT07388368

Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers

This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Force Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

Location contact

Pooja Kumari

CONTACT

[email protected]

03133422793

About this study

  • The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).

All root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.

At the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.

Postoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Patients of age group 18 to 60 years
  • Healthy patients with ASA class 1 and 2
  • Patients of both genders
  • Teeth diagnosed as symptomatic irreversible pulpitis
  • Single as well as multirooted teeth

Exclusion criteria

  • Teeth with calcified or previously treated canals
  • Immunocompromised or mentally handicapped patients
  • Pregnant or lactating mothers
  • Teeth with periodontal probing depths of 5 mm or more
  • Cracked or un restorable teeth
  • Teeth where root canal instrumentation could not reach within 2 mm of the radiographic apex

Treatment and study plan

Tricalcium silicate sealar

Drug

Ceraseal (bioceramic sealer) - assigned to Group 2

Other names: CeraSeal sealer, bioceramic sealer, calcium silicate sealer

Resin Based sealer

Drug

Endoplus (resin-based sealer) - assigned to Group 1

Other names: Endoplus sealer, resin sealer, gutta-percha sealer

Primary outcomes

  1. Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)

    Time frame: 24 hours, 72 hours and 7 days

    Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.

Study contacts

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

Pooja Kumari

CONTACT

[email protected]

03133422793

Sponsors and collaborators

Lead sponsor

Armed Forces Institute of Dentistry, Pakistan

Other

Registry information

Official study title

A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

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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