- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795282
Post Operative Sensitivity of MTA Obturation
December 27, 2025 updated by: Ayşe Tuğba Eminsoy Avcı, TC Erciyes University
Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kayseri, Turkey (Türkiye), 38000
- Erciyes University Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Systemically healthy patients between the ages of 18-65
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
7-day postoperative pain after root canal treatment
Time Frame: 7 days
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2025
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
December 22, 2024
First Submitted That Met QC Criteria
January 25, 2025
First Posted (Actual)
January 28, 2025
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 27, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Stomatognathic Diseases
- Postoperative Complications
- Pathologic Processes
- Tooth Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Dental Pulp Diseases
- Tooth, Nonvital
- Amino Acids, Peptides, and Proteins
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Guanine
- Hypoxanthines
- Purinones
- Purines
- Glutamates
- Amino Acids, Acidic
- Amino Acids
- Amino Acids, Dicarboxylic
- Pemetrexed
Other Study ID Numbers
- AAvci
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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