Dental Pulp DiseaseNCT06795282
Post Operative Sensitivity of MTA Obturation
An observational study of Dental Pulp Disease and Endodontically Treated Teeth, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Disease, Endodontically Treated Teeth, Endodontic Disease
- What is being tested?
- MTA
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2025to 15 Dec 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Systemically healthy patients between the ages of 18-65
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry
Kayseri, 38000
About this study
Official title: 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.
- Being tested
- MTA
- Keywords
- MTA, Post-op pain, Epoxy resin sealer, putty MTA
- Medical subject headings
- Dental Pulp Diseases, Tooth, Nonvital, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MTA | |
| 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. Receives: Drug: MTA | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start30 Jan 2025
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Tuğba Eminsoy Avcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795282
- Sponsor's protocol ID
- AAvci
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Eminsoy Avci AT, Yavuz B, Karakaya B, Ustun Y, Aslan T. The effect of three different root canal filling materials on postoperative pain in teeth with irreversible pulpitis: a randomized clinical trial. BMC Oral Health. 2026 May 7;26(1):1204. doi: 10.1186/s12903-026-08525-x.
PubMed 42098797
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Different Root Canal Filling Materials Used in Single-Session Root Canal Treatment on Postoperative Pain: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06795282
- Acronym / sponsor ID
- AAvci
- Keywords
- MTA, Post-op pain, Epoxy resin sealer, putty MTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| powder-liquid MTA | – | Drug: MTAThe 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 | – | Drug: MTAThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Systemically healthy patients between the ages of 18-65
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTAMTA 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. | Drug | Putty MTA, powder-liquid MTA |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Derived from this study: PubMed 42098797Eminsoy Avci AT, Yavuz B, Karakaya B, Ustun Y, Aslan T. The effect of three different root canal filling materials on postoperative pain in teeth with irreversible pulpitis: a randomized clinical trial. BMC Oral Health. 2026 May 7;26(1):1204. doi: 10.1186/s12903-026-08525-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Disease and Endodontically Treated Teeth, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day postoperative pain after root canal treatment (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.