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

Armed Forces Institute of Dentistry, Pakistan

Status

Not yet enrolling

Conditions

Pain

Treatments

Drug: Tricalcium silicate sealar

Drug: Resin based sealer

Study type

Interventional

Funder types

Other

Identifiers

NCT07388368

Protocol-001

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment

118 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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