Asymptomatic Vital Mandibular Molar TeethNCT05266599
The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up
A study testing MTA Fillapex root canal sealer and AH Plus root canal sealer in people with Asymptomatic Vital Mandibular Molar Teeth, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Post-obturation pain evaluation(Part 1): One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Vital Mandibular Molar Teeth
- What is being tested?
- MTA Fillapex root canal sealer and AH Plus root canal sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2019to 7 Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Good oral hygiene
- Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries
- Teeth that have not been treated endodontically and restoratively before
- A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth
- Large pulpal perforation during caries removal
- Presence of thick and profuse pulpal bleeding could not be controlled within 5 minutes
- Absence of periapical pathology of teeth when confirmed with periapical radiographically
Who cannot join
- Patients who refused to participate in the study
- The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment
- Having a history of sensitivity to local anesthetics.
- Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment.
- Symptomatic or non-vital teeth
- Patients have more than one tooth requiring endodontic treatment
Show all 10Show fewer
- Teeth with material loss that cannot be restored, or teeth that require a post or that will be used as a supporting tooth for a prosthesis
- The presence of advanced periodontal disease (probing depth >3 mm)
- Presence of calcified root canal, presence of internal or external root resorption
- Second molars with C-shaped root canal anatomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Root Canal Sealers on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study- Part 1, Influence of Resin-based and Mineral Trioxide Aggregate-based Sealers on Treatment Outcome After Two-year Follow-up in Mandibular Molar Teeth With Asymptomatic Irreversible Pulpitis-Part 2
Post-obturation pain evaluation(Part 1):
One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were informed to record the number of analgesics they used during these time periods.
Read more
Clinical and radiological outcome evaluation(Part 2):
Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as "failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined.
Read the detailed description
This randomized clinical trial aimed to evaluate and compare the effect of MTA-based bioceramic and resin-based sealers on the incidence and intensity of post-obturation pain and clinical and radiological outcome after two-year follow-up in asymptomatic vital molar teeth in single-visit root canal treatment. One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer.
Post-obturation pain evaluation(Part 1):
Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale, and patients were informed to record the number of analgesics they used during these time periods. The Mann-Whitney U test was used to compare the postoperative pain and the analgesic use between the two groups according to NRS scores. The relationship between the number of analgesics used and the total NRS values were analyzed by Spearman Correlation Analysis. Evaluation of NRS scores at all time points for each group was done by Friedman Two-Way Analysis of Variance Test.
Clinical and radiological outcome evaluation(Part 2):
Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as"failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined. All of the pairwise comparisons between the groups at 1st and 2nd year were done by chi-square test (Fisher exact test). Pearson's chi-square test was used to evaluate the age, gender of the patients and tooth types between the groups
- Being tested
- MTA Fillapex root canal sealer, AH Plus root canal sealer
- Keywords
- asymptomatic irreversible pulpitis, bioceramic sealer, post-obturation pain, resin-based sealer, treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTA Fillapex root canal sealerOther
Root canal treatments were performed with MTA Fillapex
AH Plus root canal sealerOther
Root canal treatments were performed with AH plus
| Study group | Role | What they receive |
|---|---|---|
| MTA Fillapex group | Active comparator | Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. MTA Fillapex sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals. Receives: Other: MTA Fillapex root canal sealer |
| AH Plus group | Active comparator | Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. AH Plus sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals. Receives: Other: AH Plus root canal sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and intensity of post-obturation pain
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Measured: up to 30-day
Secondary outcomes (1)
Clinical and radiographical success with resin-based and MTA-based bioceramic sealer
The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination, swelling, pain, sinus tract, tenderness to percussion and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria (Strindberg 1956). Teeth with a normal contour, width and structure of the periodontal ligament were considered "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered "failed". A case was considered unsuccessful when at least one of the clinical and/or radiographic findings was present. Unsuccessful ones were scored as "0" and successful ones as "1".
Measured: 1 year and 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start20 Nov 2019
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic Vital Mandibular Molar TeethStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Kandemir Demirci, Ege University
- Investigators
- Gözde K Demirci, Dr, Principal investigator, Ege University Faculty of DentistryMelis Coşar, Study chair, Ege University Faculty of DentistryMehmet Kemal Çalışkan, Prof.Dr, Study chair, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266599
- Sponsor's protocol ID
- 19-11/6
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
PubMed 32183124Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.
PubMed 30397735Aslan T, Donmez Ozkan H. The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 2021 Feb;54(2):190-197. doi: 10.1111/iej.13411. Epub 2020 Oct 17.
PubMed 32929721Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
PubMed 31794999Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.
PubMed 29606401Galani 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 29061359
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Root Canal Sealers on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study- Part 1, Influence of Resin-based and Mineral Trioxide Aggregate-based Sealers on Treatment Outcome After Two-year Follow-up in Mandibular Molar Teeth With Asymptomatic Irreversible Pulpitis-Part 2
- ClinicalTrials.gov ID
- NCT05266599
- Acronym / sponsor ID
- 19-11/6
- Keywords
- asymptomatic irreversible pulpitis, bioceramic sealer, post-obturation pain, resin-based sealer, treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 4 Mar 2022 (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.
Post-obturation pain evaluation(Part 1):
One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were informed to record the number of analgesics they used during these time periods.
Clinical and radiological outcome evaluation(Part 2):
Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as "failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined.
Detailed description
This randomized clinical trial aimed to evaluate and compare the effect of MTA-based bioceramic and resin-based sealers on the incidence and intensity of post-obturation pain and clinical and radiological outcome after two-year follow-up in asymptomatic vital molar teeth in single-visit root canal treatment. One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer.
Post-obturation pain evaluation(Part 1):
Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale, and patients were informed to record the number of analgesics they used during these time periods. The Mann-Whitney U test was used to compare the postoperative pain and the analgesic use between the two groups according to NRS scores. The relationship between the number of analgesics used and the total NRS values were analyzed by Spearman Correlation Analysis. Evaluation of NRS scores at all time points for each group was done by Friedman Two-Way Analysis of Variance Test.
Clinical and radiological outcome evaluation(Part 2):
Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as"failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined. All of the pairwise comparisons between the groups at 1st and 2nd year were done by chi-square test (Fisher exact test). Pearson's chi-square test was used to evaluate the age, gender of the patients and tooth types between the groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Fillapex group | Active comparator | Other: MTA Fillapex root canal sealerRoot canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. MTA Fillapex sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals. |
| AH Plus group | Active comparator | Other: AH Plus root canal sealerRoot canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. AH Plus sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients older than 18 years
- Good oral hygiene
- Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries
- Teeth that have not been treated endodontically and restoratively before
- A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth
Key exclusion criteria (10 listed)
- Patients who refused to participate in the study
- The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment
- Having a history of sensitivity to local anesthetics.
- Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment.
- Symptomatic or non-vital teeth
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 |
|---|---|---|
| MTA Fillapex root canal sealerRoot canal treatments were performed with MTA Fillapex | Other | MTA Fillapex group |
| AH Plus root canal sealerRoot canal treatments were performed with AH plus | Other | AH Plus group |
Primary outcome
The incidence and intensity of post-obturation pain
Time frame: up to 30-day
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
1 secondary outcome
Clinical and radiographical success with resin-based and MTA-based bioceramic sealer
Time frame: 1 year and 2 year follow-up
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 4 Mar 2022.
- Background: PubMed 32183124Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
- Results publication: PubMed 30397735Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.
- Results publication: PubMed 32929721Aslan T, Donmez Ozkan H. The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 2021 Feb;54(2):190-197. doi: 10.1111/iej.13411. Epub 2020 Oct 17.
- Results publication: PubMed 31794999Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
- Results publication: PubMed 29606401Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.
- Results publication: 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.
- Individual participant dataSharing planned: No
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.
Gözde K Demirci, Dr principal investigator
Ege University Faculty of Dentistry
Melis Coşar study chair
Ege University Faculty of Dentistry
Mehmet Kemal Çalışkan, Prof.Dr study chair
Ege University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTA Fillapex root canal sealer and AH Plus root canal sealer in people with Asymptomatic Vital Mandibular Molar Teeth, run by Ege 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 8 inclusion and 10 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 4 Mar 2022. 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?
The incidence and intensity of post-obturation pain (time frame: up to 30-day). 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 NCT05266599, which also lists 6 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 4 Mar 2022.