Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
Conditions
Keywords
Post endodontic pain, Symptomatic irreversible pulpitis, Single cone obturation
Brief summary
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
Interventions
PROCEDUREEndoseal TCS
Bioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment
PROCEDURENeosealer
Fast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment
PROCEDUREAH Plus
Epoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Endodontic Pain Intensity | Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Consumption | Within 48 hours post-treatment | Total number of analgesic tablets consumed by participants during the first 48 hours after treatment |
Countries
Iran
Contacts
PRINCIPAL_INVESTIGATORShole Ghabraei, Professor
Tehran university of medical science, school of dentistry
PRINCIPAL_INVESTIGATORHadi Assadian, Assistant Professor
Tehran university of medical science, school of dentistry
Outcome results
None listed