Post-operative PainNCT05923619
Evaluation of Post-operative Pain After Total Pulpotomy and Root Canal Treatment
A study testing Total pulpotomy and Root canal treatment in people with Post-operative Pain and Pulpitis - Irreversible, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare post-operative pain following total pulpotomy (TP) and root canal treatment (RCT) in mature molar teeth with severe symptoms indicative of irreversible pulpitis. To compare the traditional pulpitis classification with the Wolters system in evaluating post-operative pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Pulpitis - Irreversible
- What is being tested?
- Total pulpotomy and Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2023to 13 Oct 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Standard periodontal pocket depth and mobility,
- Deep/extreme deep caries (periapical radiography),
- Diagnosed with moderate and severe pulpitis according to the Wolters classification,
- Had a positive response to the cold test,
- Mandibular first and second molar teeth with completed root development.
Who cannot join
- Patients who had received antibiotic therapy in the last three months or used non-steroidal anti-inflammatory drugs within the last twelve hours,
- Patients with diabetes or immunosuppressive disease or pregnancy,
- Teeth that cannot be restored or require post-core,
- Sinus tract or abscess,
- Did not respond to pulp sensitivity test (cold test),
- Teeth with no exposed pulp after non-selective caries removal.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
Hatay, Antakya, 31000
About this study
Official title: Comparison of Post-operative Pain After Total Pulpotomy and Root Canal Treatment in Mature Molars According to New and Traditional Classification of Pulpitis: A Randomized Controlled Trial
The aim of this study was to compare post-operative pain following total pulpotomy (TP) and root canal treatment (RCT) in mature molar teeth with severe symptoms indicative of irreversible pulpitis. To compare the traditional pulpitis classification with the Wolters system in evaluating post-operative pain.
Materials and Methods: Sixty-four mature mandibular molar with symptomatic vital pulps in patients aged 18-60 years were included and were classified according to the Wolters (moderate/severe pulpitis) and the traditional pulpitis classification (reversible/irreversible pulpitis). The teeth randomly divided into 2 groups. RCT was performed, using standardized protocols. TP was performed to the level of the canal orifices, and haemostasis was achieved with 2.5% NaOCl. 3 mm layer of MTA was placed as the pulpotomy agent. The treated teeth were restored with glass ionomer cement followed by composite. Pain was recorded 6, 12, 24, 48, 72 hours and 7 days after treatment. The data collected were statistically analyzed
Read the detailed description
The literature does not contain any studies comparing the effects of TP and RCT procedures on post-operative pain in mature molar teeth diagnosed with irreversible pulpitis and severe symptoms. Therefore, this study evaluated the effect of pre-operative and intra-operative variables and the treatment method on post-operative pain.
Patient evaluation and treatment procedure
As a result of clinical and radiographic examination, the teeth were classified both according to American Association of Endodontists (AAE) and as proposed by Wolters. The presence/absence of percussion was noted. Pre-operative pain levels were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories:
No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm). After inferior alveolar nerve block anesthesia was performed with local anesthetic (adrenaline 4% Articaine, 1:100,000), the tooth was isolated with a rubber dam. The isolated area was cleaned using a cotton pellet wetted first with 3% hydrogen peroxide and then 2% chlorhexidine. The entire caries was removed non-selectively using a high-speed diamond bur under water coolant followed by a sterile round steel bur in a slow handpiece. After the pulp exposure was clinically confirmed, the patient was assigned to the TP or RCT group. Randomization was performed using online software with a four-block size block randomization technique to ensure even distribution between the groups (www.randomizer.org). The clinician could not be blinded due to the stages of treatment.
Both patients were prescribed 400 mg of ibuprofen following treatment and asked to use it if necessary. They were informed to consult the clinic in case of severe post-operative pain that was not relieved by analgesics. All participants were administered a questionnaire form based on HP VAS, which could show their pain and analgesic intake after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and seven days. Patients were asked to fill in the form. Patients were invited for clinical examination one week after treatment, and follow-up appointments were scheduled for three months, six months, and one year for patients who were observed to be asymptomatic.
- Conditions
- Post-operative Pain, Pulpitis - Irreversible
- Being tested
- Total pulpotomy, Root canal treatment
- Keywords
- irreversibl pulpitis, mineral trioxide aggregate, post-operative pain, total pulpotomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total pulpotomyProcedure or surgery
Total pulpotomy procedures explained in arm descriptions.
Root canal treatmentProcedure or surgery
Root canal treatment procedures explained in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Total pulpotomy | Experimental | The coronal pulp tissue was completely removed with a high-speed sterile carbide bur under abundant water coolant. A cotton pellet moistened with 2.5% sodium hypochlorite was used to achieve hemostasis. Following the achievement of hemostasis, an average of 3 mm thick MTA material (Angelus, Londrina, PR, Brazil) was used to cover the pulp chamber. In the same session, the pulp chamber was closed with approximately 2 mm thick flowable glass ionomer cement (Glass Liner, WP), and coronal restoration was completed with composite filling (Estelıte® Sıgma Quıck, Tokuyama). Receives: Procedure: Total pulpotomy |
| Root canal treatment | Active comparator | The working length was determined using a 15 K type file and apex locator (Morita Root ZX, Tokyo, Japan) and checked by radiography. The chemomechanical preparation was completed using the R25 (Resiproc, VDW, Munich, Germany) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, at the WL. During the chemomechanical preparation, the root canals were irrigated with 2.5% NaOCl after every three pecking motions; and total volume of NaOCl was 10 ml. In the final irrigation, the root canal was irrigated with 5 ml 17% Ethylene diamine tetraacetic acid (EDTA), for 1 minute, following with 2 ml distilled water. Following the retention of 5 ml of 2.5% NaOCl in the root canal for 1 minute, 5 ml of distilled used to neutralize the effect of NaOCl in the root canal.Tthe root canals were filled with the lateral condensation using epoxy-resin-based sealer (AH Plus, Dentsply DeTrey GmbH, Konstanz, Germany). Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories:
No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start13 Jan 2023
- Primary completion6 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sari, Mustafa Kemal University
- Investigators
- Merve Sarı, DDS, Principal investigator, Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal UniversityKoray Yılmaz, Study director, Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923619
- Sponsor's protocol ID
- 2308
- Status last verified
- Apr 2024
- First submitted
- 16 Jun 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sabeti M, Huang Y, Chung YJ, Azarpazhooh A. Prognosis of Vital Pulp Therapy on Permanent Dentition: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Nov;47(11):1683-1695. doi: 10.1016/j.joen.2021.08.008. Epub 2021 Sep 1.
PubMed 34478787Levin LG, Law AS, Holland GR, Abbott PV, Roda RS. Identify and define all diagnostic terms for pulpal health and disease states. J Endod. 2009 Dec;35(12):1645-57. doi: 10.1016/j.joen.2009.09.032.
PubMed 19932339Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.
PubMed 22099859Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
PubMed 35152464Careddu R, Duncan HF. A prospective clinical study investigating the effectiveness of partial pulpotomy after relating preoperative symptoms to a new and established classification of pulpitis. Int Endod J. 2021 Dec;54(12):2156-2172. doi: 10.1111/iej.13629. Epub 2021 Sep 26.
PubMed 34490637Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
PubMed 28776717Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.
PubMed 28836288Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
PubMed 35226769Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
PubMed 29061359Sari M, Yilmaz K, Ozyurek T. Postoperative pain after total pulpotomy and root canal treatment in mature molars according to the new and traditional classifications of pulpitis: a prospective, randomized controlled trial. BMC Oral Health. 2024 Sep 12;24(1):1075. doi: 10.1186/s12903-024-04836-z.
PubMed 39266985
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Pain After Total Pulpotomy and Root Canal Treatment in Mature Molars According to New and Traditional Classification of Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05923619
- Acronym / sponsor ID
- 2308
- Conditions
- Post-operative Pain, Pulpitis - Irreversible
- Keywords
- irreversibl pulpitis, mineral trioxide aggregate, post-operative pain, total pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 28 Jun 2023 (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 compare post-operative pain following total pulpotomy (TP) and root canal treatment (RCT) in mature molar teeth with severe symptoms indicative of irreversible pulpitis. To compare the traditional pulpitis classification with the Wolters system in evaluating post-operative pain.
Materials and Methods: Sixty-four mature mandibular molar with symptomatic vital pulps in patients aged 18-60 years were included and were classified according to the Wolters (moderate/severe pulpitis) and the traditional pulpitis classification (reversible/irreversible pulpitis). The teeth randomly divided into 2 groups. RCT was performed, using standardized protocols. TP was performed to the level of the canal orifices, and haemostasis was achieved with 2.5% NaOCl. 3 mm layer of MTA was placed as the pulpotomy agent. The treated teeth were restored with glass ionomer cement followed by composite. Pain was recorded 6, 12, 24, 48, 72 hours and 7 days after treatment. The data collected were statistically analyzed
Detailed description
The literature does not contain any studies comparing the effects of TP and RCT procedures on post-operative pain in mature molar teeth diagnosed with irreversible pulpitis and severe symptoms. Therefore, this study evaluated the effect of pre-operative and intra-operative variables and the treatment method on post-operative pain.
Patient evaluation and treatment procedure
As a result of clinical and radiographic examination, the teeth were classified both according to American Association of Endodontists (AAE) and as proposed by Wolters. The presence/absence of percussion was noted. Pre-operative pain levels were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories:
No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm). After inferior alveolar nerve block anesthesia was performed with local anesthetic (adrenaline 4% Articaine, 1:100,000), the tooth was isolated with a rubber dam. The isolated area was cleaned using a cotton pellet wetted first with 3% hydrogen peroxide and then 2% chlorhexidine. The entire caries was removed non-selectively using a high-speed diamond bur under water coolant followed by a sterile round steel bur in a slow handpiece. After the pulp exposure was clinically confirmed, the patient was assigned to the TP or RCT group. Randomization was performed using online software with a four-block size block randomization technique to ensure even distribution between the groups (www.randomizer.org). The clinician could not be blinded due to the stages of treatment.
Both patients were prescribed 400 mg of ibuprofen following treatment and asked to use it if necessary. They were informed to consult the clinic in case of severe post-operative pain that was not relieved by analgesics. All participants were administered a questionnaire form based on HP VAS, which could show their pain and analgesic intake after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and seven days. Patients were asked to fill in the form. Patients were invited for clinical examination one week after treatment, and follow-up appointments were scheduled for three months, six months, and one year for patients who were observed to be asymptomatic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total pulpotomy | Experimental | Procedure: Total pulpotomyThe coronal pulp tissue was completely removed with a high-speed sterile carbide bur under abundant water coolant. A cotton pellet moistened with 2.5% sodium hypochlorite was used to achieve hemostasis. Following the achievement of hemostasis, an average of 3 mm thick MTA material (Angelus, Londrina, PR, Brazil) was used to cover the pulp chamber. In the same session, the pulp chamber was closed with approximately 2 mm thick flowable glass ionomer cement (Glass Liner, WP), and coronal restoration was completed with composite filling (Estelıte® Sıgma Quıck, Tokuyama). |
| Root canal treatment | Active comparator | Procedure: Root canal treatmentThe working length was determined using a 15 K type file and apex locator (Morita Root ZX, Tokyo, Japan) and checked by radiography. The chemomechanical preparation was completed using the R25 (Resiproc, VDW, Munich, Germany) file in the mesial root canals and the R25, R40, and R50 files in the distal root canals, respectively, at the WL. During the chemomechanical preparation, the root canals were irrigated with 2.5% NaOCl after every three pecking motions; and total volume of NaOCl was 10 ml. In the final irrigation, the root canal was irrigated with 5 ml 17% Ethylene diamine tetraacetic acid (EDTA), for 1 minute, following with 2 ml distilled water. Following the retention of 5 ml of 2.5% NaOCl in the root canal for 1 minute, 5 ml of distilled used to neutralize the effect of NaOCl in the root canal.Tthe root canals were filled with the lateral condensation using epoxy-resin-based sealer (AH Plus, Dentsply DeTrey GmbH, Konstanz, Germany). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Standard periodontal pocket depth and mobility,
- Deep/extreme deep caries (periapical radiography),
- Diagnosed with moderate and severe pulpitis according to the Wolters classification,
- Had a positive response to the cold test,
- Mandibular first and second molar teeth with completed root development.
Key exclusion criteria (6 listed)
- Patients who had received antibiotic therapy in the last three months or used non-steroidal anti-inflammatory drugs within the last twelve hours,
- Patients with diabetes or immunosuppressive disease or pregnancy,
- Teeth that cannot be restored or require post-core,
- Sinus tract or abscess,
- Did not respond to pulp sensitivity test (cold test),
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 |
|---|---|---|
| Total pulpotomyTotal pulpotomy procedures explained in arm descriptions. | Procedure or surgery | Total pulpotomy |
| Root canal treatmentRoot canal treatment procedures explained in arm descriptions. | Procedure or surgery | Root canal treatment |
Primary outcome
post-operative pain
Time frame: 1 week
Pre-operative and post-operative pain scores were determined according to the Heft-Parker Visual Analog Scale (HP VAS), which consisted of a 10 mm long horizontal line where numerical values were divided into visual categories. Patients were instructed to score their pain with a value on the HP VAS. The presence or absence of pain was classified according to 4 categories: No pain (level 1, 0), Mild pain (level 2, 1-3 mm), Moderate pain (level 3, 4-6mm), Severe pain (level 4, 7-10 mm).
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 16 Apr 2024.
- Background: PubMed 34478787Sabeti M, Huang Y, Chung YJ, Azarpazhooh A. Prognosis of Vital Pulp Therapy on Permanent Dentition: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Nov;47(11):1683-1695. doi: 10.1016/j.joen.2021.08.008. Epub 2021 Sep 1.
- Background: PubMed 19932339Levin LG, Law AS, Holland GR, Abbott PV, Roda RS. Identify and define all diagnostic terms for pulpal health and disease states. J Endod. 2009 Dec;35(12):1645-57. doi: 10.1016/j.joen.2009.09.032.
- Background: PubMed 22099859Ricucci D, Russo J, Rutberg M, Burleson JA, Spangberg LS. A prospective cohort study of endodontic treatments of 1,369 root canals: results after 5 years. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):825-42. doi: 10.1016/j.tripleo.2011.08.003.
- Background: PubMed 35152464Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.
- Background: PubMed 34490637Careddu R, Duncan HF. A prospective clinical study investigating the effectiveness of partial pulpotomy after relating preoperative symptoms to a new and established classification of pulpitis. Int Endod J. 2021 Dec;54(12):2156-2172. doi: 10.1111/iej.13629. Epub 2021 Sep 26.
- Background: PubMed 28776717Wolters WJ, Duncan HF, Tomson PL, Karim IE, McKenna G, Dorri M, Stangvaltaite L, van der Sluis LWM. Minimally invasive endodontics: a new diagnostic system for assessing pulpitis and subsequent treatment needs. Int Endod J. 2017 Sep;50(9):825-829. doi: 10.1111/iej.12793. No abstract available.
- Background: PubMed 28836288Parirokh M, Torabinejad M, Dummer PMH. Mineral trioxide aggregate and other bioactive endodontic cements: an updated overview - part I: vital pulp therapy. Int Endod J. 2018 Feb;51(2):177-205. doi: 10.1111/iej.12841. Epub 2017 Sep 21.
- Background: PubMed 35226769Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.
- Background: PubMed 29061359Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
- Derived from this study: PubMed 39266985Sari M, Yilmaz K, Ozyurek T. Postoperative pain after total pulpotomy and root canal treatment in mature molars according to the new and traditional classifications of pulpitis: a prospective, randomized controlled trial. BMC Oral Health. 2024 Sep 12;24(1):1075. doi: 10.1186/s12903-024-04836-z.
- Individual participant dataSharing planned: No
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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.
Merve Sarı, DDS principal investigator
Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
Koray Yılmaz study director
Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total pulpotomy and Root canal treatment in people with Post-operative Pain and Pulpitis - Irreversible, run by Mustafa Kemal 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 5 inclusion and 6 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 16 Apr 2024. 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?
post-operative pain (time frame: 1 week). 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 NCT05923619, which also lists 10 linked publications.
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 16 Apr 2024.