Comparative Evaluation Of Post Operative Pain On Unintentional Extrusion Of Three Different Root Canal Sealers Periapically: A Ramdomised Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Anuj Bhardwaj
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
This clinical trial will investigate postoperative pain associated with unintentional periapical extrusion of three types of root canal sealers: a bioceramic, an MTA-based, and a resin-based sealer. Adult patients will be enrolled for primary endodontic treatment of first molars that could be completed in single visit. After providing informed consent, patients will be randomized to a parallel group using concealed allocation. Clinicians will be blinded to the randomization assignment while completing the protocol. Each patient will receive treatment consisting of consistent, obturation by warm vertical compaction to a standardized size. If sealer extrusion occurs, it will be documented via radiograph. The primary outcome will be postoperative pain, assessed on a 100-mm visual analog scale at 6, 24, 48, and 72 hours after treatment. Secondary outcomes will include the analgesics taken, flare-ups, and visits to urgent care. Intention-to-treat analyses will compare pain trajectories and peak pain using mixed models and contrasts across groups. In total, this study aims to determine whether differences in sealer chemistry will have a significant impact on early postoperative pain if periapical extrusion occurs and provide further consideration on sealers most appropriate for patient comfort and clinical utility.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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.
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.
Outcomes
Primary Outcomes
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.
Time Frame: Immediate | 12 hours | 24 hours | 72 hours | and | 1 week
Secondary Outcomes
- Incidence of postoperative flare-up—defined as severe pain and/or swelling requiring unscheduled care or intra-canal intervention.(Seven days after treatment.)
Investigators
Anuj Bhardwaj
College of Dental Sciences & Hospital