Pain, AcuteNCT04262362
The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments
An observational study of Pain, Acute and Necrotic Pulp, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Acute, Necrotic Pulp
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2019to 14 Sep 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient refer for routine endodontic treatment will be included.
Who may be able to join
- Requirement of root canal treatment
Who cannot join
- Sodium hypochlorite allergy
- Immature tooth
- root resorption
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bülent Ecevit University, Faculty of Dentistry
Zonguldak, 67600
Mustafa M Koçak, 0905053194378, mmuratkocak@beun.edu.tr
About this study
Official title: The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments: A Clinical Study
Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.
Read the detailed description
Sodium hypochlorite (NaOCl) is a gold standard irrigation solution that has antimicrobial and tissue solvent effect. Until now, there is no other alternative that provides its activity characteristics. Although it represents many advantages, and it is usually considered safe, some cases of mishap and systematic reviews about case reports of NaOCl accident especially during endodontic procedures, have been reported in the literature. NaOCl may lead potentially very damaging injuring results with acute pain, swelling, hemolysis, ulceration, inhibition of neutrophil migration, endothelial and fibroblast cell damage, nerve weakness or damage, trismus and tissue necrosis if it overflows the periapical area.
The aim of this prospective observational investigation is to determinate the frequency of the extrusion in endodontically treated teeth.
The patients who applied to the clinic for dental treatment will be identified as having root canal treatment indication for at least one tooth. After the detailed medical and dental history will be obtained, the written consent form was taken from the patients who wanted to participate in the study. Age, gender, medical history, preoperative pain and pulpal status, having any periapical radiolusency of the related tooth will be recorded and root canal treatment will be performed according to routine procedures. After treatment, the code of tooth according to FDI classification, number of root, apical diameter, volume and concentration of irrigation solution will be recorded.
Routine treatment follow-up will be performed in patients who has no NaOCl overflow from the root during procedure. The patients with NaOCl overflow during the treatment process, appropriate treatment will be planned and followed up until symptoms regress.
- Conditions
- Pain, Acute, Necrotic Pulp
- Being tested
- Root canal treatment
- Medical subject headings
- Acute Pain, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
Incidence of pain that may occur due to sodium hypochlorite extrusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pain and symptoms
pain or other symptoms due to sodium hypochlorite extrusion
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start5 Dec 2019
- Primary completion14 Sep 2020 (estimated)
- Study completion14 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Murat Koçak, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262362
- Sponsor's protocol ID
- Bülent Ecevit universi
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments: A Clinical Study
- ClinicalTrials.gov ID
- NCT04262362
- Acronym / sponsor ID
- Bülent Ecevit universi
- Conditions
- Pain, Acute, Necrotic Pulp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 14 Sep 2020 (estimated)
- Study completion
- 14 Sep 2020 (estimated)
- First posted
- 10 Feb 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.
Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.
Detailed description
Sodium hypochlorite (NaOCl) is a gold standard irrigation solution that has antimicrobial and tissue solvent effect. Until now, there is no other alternative that provides its activity characteristics. Although it represents many advantages, and it is usually considered safe, some cases of mishap and systematic reviews about case reports of NaOCl accident especially during endodontic procedures, have been reported in the literature. NaOCl may lead potentially very damaging injuring results with acute pain, swelling, hemolysis, ulceration, inhibition of neutrophil migration, endothelial and fibroblast cell damage, nerve weakness or damage, trismus and tissue necrosis if it overflows the periapical area.
The aim of this prospective observational investigation is to determinate the frequency of the extrusion in endodontically treated teeth.
The patients who applied to the clinic for dental treatment will be identified as having root canal treatment indication for at least one tooth. After the detailed medical and dental history will be obtained, the written consent form was taken from the patients who wanted to participate in the study. Age, gender, medical history, preoperative pain and pulpal status, having any periapical radiolusency of the related tooth will be recorded and root canal treatment will be performed according to routine procedures. After treatment, the code of tooth according to FDI classification, number of root, apical diameter, volume and concentration of irrigation solution will be recorded.
Routine treatment follow-up will be performed in patients who has no NaOCl overflow from the root during procedure. The patients with NaOCl overflow during the treatment process, appropriate treatment will be planned and followed up until symptoms regress.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient refer for routine endodontic treatment will be included.
Key inclusion criteria (1 listed)
- Requirement of root canal treatment
Key exclusion criteria (3 listed)
- Sodium hypochlorite allergy
- Immature tooth
- root resorption
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 treatmentIncidence of pain that may occur due to sodium hypochlorite extrusion | Procedure or surgery | – |
Primary outcome
Incidence of pain and symptoms
Time frame: During treatment
pain or other symptoms due to sodium hypochlorite extrusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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.
Bülent Ecevit University, Faculty of Dentistry
Zonguldak, Turkey (Türkiye)
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 Pain, Acute and Necrotic Pulp, run by Bulent Ecevit 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Feb 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pain and symptoms (time frame: During treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2020.