Postoperative Pain After Single-Cone Root Canal Obturation Using Three Sealers

N/AActive Not RecruitingNCT07434141

Tehran University of Medical Sciences75 enrolled

Overview

The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment. The main questions this study aims to answer are: Does the type of root canal sealer affect the intensity of pain after treatment? Does the type of sealer influence the number of analgesic tablets taken by participants? How does pain change over time after treatment with different sealers? Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain. Participants will: Receive root canal treatment using one of the study sealers Report their pain intensity at specific time points after treatment Record the number of analgesic tablets taken during the follow-up period

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Symptomatic Irreversible Pulpitis (SIP)Symptomatic Irreversible Pulpitis With Apical Peridontitis

Interventions

Endoseal TCSPROCEDURE

Bioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment

NeosealerPROCEDURE

Fast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment

AH PlusPROCEDURE

Epoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 60 years * Adequate oral and dental hygiene * Prolonged positive response to cold test and electric pulp testing * Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular) * Pulp exposure during caries removal accompanied by severe and profuse hemorrhage * No radiographic evidence of periapical lesions * Teeth with adequate restorative potential * Absence of periodontal disease Exclusion Criteria: * Teeth that are non-restorable * Presence of endodontic-periodontal (endo-perio) lesions * Teeth with radiographic evidence of periapical lesions * Teeth with internal or external root resorption * Patients with systemic diseases classified as ASA II or higher * Patients with a history of migraine * Teeth with over-obturation or under-obturation greater than 2 mm from the radiographic apex * Patients taking anti-anxiety medications * Procedural duration exceeding two hours * Known allergy to materials used in root canal treatment, including local anesthetics

Outcomes

Primary Outcomes

Post-Endodontic Pain Intensity

Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain intensity (worse outcome). Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment. The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome

Time frame: Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment

Secondary Outcomes

Analgesic Consumption

Total number of analgesic tablets consumed by participants during the first 48 hours after treatment

Time frame: Within 48 hours post-treatment