Post Operative Sensitivity of MTA Obturation
Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study
1 other identifier
observational
54
1 country
1
Brief Summary
The aim of this study was to investigate the difference in postoperative pain caused by different root canal sealers in patients with irreversible pulpitis symptoms and no apical lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedJanuary 2, 2026
December 1, 2025
10 months
December 22, 2024
December 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day postoperative pain after root canal treatment
At the end of the visit, patients were educated to record their postoperative pain level by assigning a number between 0 and 10 using the numerical rating scale (NRS) chart. They were categorized into four: 0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-10=severe pain. The patients were asked to record their pain level preoperatively, at 6, 12, and 24 h, and daily for up to 7 days, and return it to he investigators at a specific time.
7 days
Study Arms (3)
powder-liquid MTA
The root canal will be filled with MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.
Putty MTA
The root canal will be filled with putty MTA at the end of the first session and patients will fill out a post-op pain form for 1 week.
Epoxy resin sealer
The root canal will be filled with epoxy resin sealer and gutta-percha at the end of the first session and patients will fill out a post-op pain form for 1 week.
Interventions
MTA is primarily composed of tricalcium silicate, dicalcium silicate, bismuth oxide (for radiopacity), and small amounts of calcium sulfate. MTA is highly biocompatible, making it suitable for use in the root canal system and areas in close contact with tissues.
Eligibility Criteria
Systemically healthy patients between the ages of 18-65
You may qualify if:
- asymptomatic tooth with delayed positive response to thermal tests and electric pulp tests
- large pulp perforation during caries removal,
- inflamed pulp in which bleeding could not be controlled within 5 min,
- periodontally healthy mature mandibular first or second molar tooth.
You may not qualify if:
- patients if they were diabetic, immunocompromised, pregnant,
- had a positive history of antibiotic use during the past 1 month,
- required antibiotic prophylaxis
- used analgesic within 7 days prior to the beginning of treatment,
- were allergic to the materials used during root canal treatment,
- if the bleeding could be controlled within 5 min and vital pulp treatment could be performed,
- the tooth had negative response to vitality tests and/or was symptomatic,
- had an associated periapical lesion visible on a radiograph,
- needed a post-core or was planned to serve as prosthetic support,
- had a calcified root canal and internal or external root resorption,
- had tooth with open apex
- mandibular third molars
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University Faculty of Dentistry
Kayseri, 38000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 22, 2024
First Posted
January 28, 2025
Study Start
January 30, 2025
Primary Completion
December 1, 2025
Study Completion
December 15, 2025
Last Updated
January 2, 2026
Record last verified: 2025-12