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Do Root Canal Sealers Cause Pain After Treatment? A Clinical Trial Comparing Three Sealers

Comparative Evaluation Of Post Operative Pain On Unintentional Extrusion Of Three Different Root Canal Sealers Periapically: A Ramdomised Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097854
Enrollment
200
Registered
2025-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K04- Diseases of pulp and periapical tissues

Interventions

Intervention1: Group 1 Biceramic Sealer: The single visit root canal treatment will be done and after cleaning and shaping the root canals will be obdurated with bioceramic sealer. Intervention2: Grou

Sponsors

Anuj Bhardwaj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Two hundred consecutive patients aged 18 65 years will be screened for eligibility. Participants with a clinical diagnosis of symptomatic irreversible pulpitis, with or without clinical signs of apical periodontitis, involving a maxillary or mandibular first molar with fully developed roots and no radiographic evidence of a periapical lesion will be included. Pulp sensibility will be assessed using a cold test (Endo-Ice, Hygienic, Akron, OH, USA) and an electric pulp tester. A preoperative periapical radiograph will be obtained using radiovisiography (RVG; Vatech India, New Delhi, India).

Exclusion criteria

Exclusion criteria: Non-vital teeth defined as a negative response to thermal stimulation (with Endo-Ice) and verified by the absence of bleeding in the access cavity preparation (see below) will be one exclusion criterion. Prior endodontic retreatment, second or third molars, or teeth with a specific intent for root canal treatment will be excluded. Teeth with periapical radiolucency, root resorption, immature or open apices, root caries, or extensive structural loss decided non-restorable will be excluded. Teeth exhibiting pathologic mobility, complex root anatomy, and patient-related exclusion criteria will also be excluded. Participants who do not wish to comply, those who have taken analgesics and/or anti-inflammatories (steroidal or nonsteroidal) within the prior twelve hours, pregnant or breastfeeding individuals, those with uncontrolled systemic disease, and participants outside the trial s adult age range (younger than eighteen years or older than sixty-five years) will be excluded as part of the exclusion criteria.

Design outcomes

Primary

MeasureTime frame
The main outcome will be the severity of postoperative pain, measured on a visual analogue scale (VAS) ranging from 0-100 millimetres. Patients will be given a take-home VAS to help the outcome assessor obtain postoperative pain levels in their questionnaires.Timepoint: Immediate 12 hours 24 hours 72 hours and 1 week

Secondary

MeasureTime frame
Incidence of postoperative flare-up defined as severe pain and/or swelling requiring unscheduled care or intra-canal intervention.Timepoint: Seven days after treatment.

Countries

India

Contacts

Public ContactAnuj Bhardwaj

College of Dental Sciences & Hospital

dranuj_84@yahoo.co.in7898540222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026