Pain, PostoperativePhase 4NCT04228913

Effect of Different Obturation Techniques on Postoperative Pain

A Phase 4 study testing Root Canal Obturation Technique in people with Pain, Postoperative and Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study evaluated the postoperative pain after the endodontic treatment by using three different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2)) Read more about this study

Who is it for?: Ages 18 to 72 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Pain, Endodontic Inflammation
What is being tested?: Root Canal Obturation Technique
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 31 Aug 2017to 15 Aug 2019
Phase: Phase 4
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 72 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Participants between 18 - 72 years of ages,
2 Good oral hygiene,
3. Have not taken any analgesic in the last 7 days,
4. Have not taken any antibiotics in the last 7 days,
5. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),
6. Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,

Show all 9Show fewer

7. Patients have single-rooted teeth requiring endodontic treatment according to the pre-prosthetic reason,
8.The presence of profusely pulp bleeding with a thick consistency, which is exposed during caries removing.
9. The periapical region was healthy in radiographic diagnosis.

Who cannot join

Patients who refuse to participate in this study,
Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
Devital teeth that have no response to pulp test,
The presence of advanced periodontal disease (probing depth > 4 mm),
The presence of open apex,
The presence of calcification,

Show all 13Show fewer

The presence of resorption,
Patients who had multiple teeth requiring endodontic treatment,
Patients with allergic sensitivity to materials and agents that should be used during the root canal treatment,
Allergic sensitivity to local anesthetics,
Patients who had systemic or allergic sensitivity for the NSAIDs,
Pregnant participants or participants in the lactation period,
Teeth cannot be applied to a rubber-dam.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hicran Dönmez Özkan
Aydin, 09100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Postoperative Pain Intensity After Three Different Obturation Techniques: A Randomized Clinical Trial

Conditions: Pain, Postoperative, Pain, Endodontic Inflammation
Being tested: Root Canal Obturation Technique
Keywords: cold lateral condensation, Postoperative Pain, GuttaCore, GuttaFlow 2, Obturation Techniques
Medical subject headings: Pain, Postoperative, Pain, Pulpitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Root Canal Obturation TechniqueOther
This study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy

Study groups in NCT04228913
Study group	Role	What they receive
Ah plus	Other	The root canals obturated with Ah plus root canal sealer (Dentsply, Sirona) and gutta-percha cones with cold lateral condensation technique. Receives: Other: Root Canal Obturation Technique
ROEKO GuttaFlow® 2	Other	The root canals obturated with GuttaFlow 2 root canal sealer (Coltene,Whaledent) and single tapered gutta-percha cone with cold free flow compaction technique. Receives: Other: Root Canal Obturation Technique
GuttaCore Obturators	Other	The root canals obturated with GuttaCore obturators (Dentsply,Sirona) and Ah plus root canal sealer with thermoplasticized solid-core carrier technique Receives: Other: Root Canal Obturation Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 6th hours.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 12th hours.
ased on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 12th hours.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 24th hours
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 24th hours.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 2nd days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 2nd days
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 3th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 3th days
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 4th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 4th days.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 5th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 5th days
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 6th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 6th days
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 7th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Measured: 7th days

Secondary outcomes (9)

Analgesic intake comparison after root canal obturation with three different obturation technique at 6th hours
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 6th hours.
Analgesic intake comparison after root canal obturation with three different obturation technique at 12th hours
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 12th hours
Analgesic intake comparison after root canal obturation with three different obturation technique at 24th hours
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 24th hours.
Analgesic intake comparison after root canal obturation with three different obturation technique at 2nd days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 2nd days
Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 3th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 4th days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 4 th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 5th days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 5th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 6th days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 6th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 7th days
The patients were asked to choose one of the three options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep", "2: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"
Measured: 7th days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 201715 Aug 2019

First posted14 Jan 2020
Study start31 Aug 2017
Primary completion4 Mar 2019
Study completion15 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single (Participant)
Masking: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04228913
Sponsor's protocol ID: ADÜDHF 2017/021
Status last verified: Jan 2020
First submitted: 7 Jan 2020
Last updated: 14 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martin-Gonzalez J, Lopez-Frias FJ, Segura-Egea JJ. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e721-7. doi: 10.4317/medoral.17898.
PubMed 22322522
Su Y, Wang C, Ye L. Healing rate and post-obturation pain of single- versus multiple-visit endodontic treatment for infected root canals: a systematic review. J Endod. 2011 Feb;37(2):125-32. doi: 10.1016/j.joen.2010.09.005. Epub 2010 Nov 12.
PubMed 21238790
Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
PubMed 29571915
Kocer A, Donmez Ozkan H, Turk T. Postoperative pain intensity and incidence following single visit root canal treatment with different obturation techniques: a randomized clinical trial. PeerJ. 2022 Jul 27;10:e13756. doi: 10.7717/peerj.13756. eCollection 2022.
PubMed 35915749

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Postoperative Pain Intensity After Three Different Obturation Techniques: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04228913
Acronym / sponsor ID: ADÜDHF 2017/021
Conditions: Pain, Postoperative, Pain, Endodontic Inflammation
Keywords: cold lateral condensation, Postoperative Pain, GuttaCore, GuttaFlow 2, Obturation Techniques
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 31 Aug 2017 (actual)
Primary completion: 4 Mar 2019 (actual)
Study completion: 15 Aug 2019 (actual)
First posted: 14 Jan 2020 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3
Model description: Single (Participant)

Arm	Type	Receives
Ah plus	Other	Other: Root Canal Obturation TechniqueThe root canals obturated with Ah plus root canal sealer (Dentsply, Sirona) and gutta-percha cones with cold lateral condensation technique.
ROEKO GuttaFlow® 2	Other	Other: Root Canal Obturation TechniqueThe root canals obturated with GuttaFlow 2 root canal sealer (Coltene,Whaledent) and single tapered gutta-percha cone with cold free flow compaction technique.
GuttaCore Obturators	Other	Other: Root Canal Obturation TechniqueThe root canals obturated with GuttaCore obturators (Dentsply,Sirona) and Ah plus root canal sealer with thermoplasticized solid-core carrier technique

Who may qualify

Ages: 18 to 72 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

1. Participants between 18 - 72 years of ages,
2 Good oral hygiene,
3. Have not taken any analgesic in the last 7 days,
4. Have not taken any antibiotics in the last 7 days,
5. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),

Key exclusion criteria (13 listed)

Patients who refuse to participate in this study,
Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
Devital teeth that have no response to pulp test,
The presence of advanced periodontal disease (probing depth > 4 mm),
The presence of open apex,

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
Root Canal Obturation TechniqueThis study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy	Other	Ah plus, GuttaCore Obturators, ROEKO GuttaFlow® 2

Primary outcome

Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours.
Time frame: 6th hours.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 12th hours.
Time frame: 12th hours.
ased on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 24th hours
Time frame: 24th hours.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 2nd days.
Time frame: 2nd days
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 3th days.
Time frame: 3th days
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 4th days.
Time frame: 4th days.
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 5th days.
Time frame: 5th days
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 6th days.
Time frame: 6th days
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 7th days.
Time frame: 7th days
Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

9 secondary outcomes

Analgesic intake comparison after root canal obturation with three different obturation technique at 6th hours
Time frame: 6th hours.
Analgesic intake comparison after root canal obturation with three different obturation technique at 12th hours
Time frame: 12th hours
Analgesic intake comparison after root canal obturation with three different obturation technique at 24th hours
Time frame: 24th hours.
Analgesic intake comparison after root canal obturation with three different obturation technique at 2nd days
Time frame: 2nd days
Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days
Time frame: 3th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 4th days
Time frame: 4 th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 5th days
Time frame: 5th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 6th days
Time frame: 6th days
Analgesic intake comparison after root canal obturation with three different obturation technique at 7th days
Time frame: 7th days.

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 14 Jan 2020.
Background: PubMed 22322522Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martin-Gonzalez J, Lopez-Frias FJ, Segura-Egea JJ. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e721-7. doi: 10.4317/medoral.17898.
Background: PubMed 21238790Su Y, Wang C, Ye L. Healing rate and post-obturation pain of single- versus multiple-visit endodontic treatment for infected root canals: a systematic review. J Endod. 2011 Feb;37(2):125-32. doi: 10.1016/j.joen.2010.09.005. Epub 2010 Nov 12.
Results publication: PubMed 29571915Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
Derived from this study: PubMed 35915749Kocer A, Donmez Ozkan H, Turk T. Postoperative pain intensity and incidence following single visit root canal treatment with different obturation techniques: a randomized clinical trial. PeerJ. 2022 Jul 27;10:e13756. doi: 10.7717/peerj.13756. eCollection 2022.
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.

Hicran Dönmez Özkan study director

Adnan Menderes 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 Phase 4 study testing Root Canal Obturation Technique in people with Pain, Postoperative and Pain, run by Aydin Adnan Menderes 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 9 inclusion and 13 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 14 Jan 2020. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours. (time frame: 6th hours.). The study lists 9 primary outcomes in all. 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 NCT04228913, which also lists 4 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 14 Jan 2020.