Postoperative PainflaringNCT05169879
Influence of Early Coronal Flaring Upon Postoperative Pain After Root Canal Treatment
A study testing coronal flaring and Non coronal flaring in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this clinical study is to evaluate the influence of early coronal flaring upon postoperative pain following root canal treatment in a single session approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- coronal flaring and Non coronal flaring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2022to Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient age above 18-70 years old.
- 2. Both males and females will be included.
- 3. All patients are in a good health without systemic condition.
- 4. The offending tooth is a molar.
- 5. The offending molar is indicated for root canal treatment.
- 6. One molar for every patient.
- 7. All patients will sign an informed consent.
Who cannot join
- 1. Necrotic molars
- 2. The offending tooth has previous attempt of pulp therapy or root canal treatment.
- 3. The patient showing any clinical or radiographic evidence of periapical pathosis.
- 4. Patients received analgesics or systemic antibiotic prior to treatment.
- 5. Immunocompromised patients.
- 6. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
Show all 12Show fewer
- 7. History of cancer with radio or chemotherapy.
- 8. Offending molar with mobility score ≥2.
- 9. Offending molar with pocket depth ≥6mm.
- 10. Immature molars.
- 11. Nonodontogenic pain.
- 12. Patients with more than one tooth requiring endodontic intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Early Coronal Flaring Upon Postoperative Pain Following Root Canal Treatment. A Randomized Clinical Trial
The aim of this clinical study is to evaluate the influence of early coronal flaring upon postoperative pain following root canal treatment in a single session approach.
Read the detailed description
All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.
Canals will be scouted using manual patency file in a watch winding maneuver. In group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. In group B no coronal flaring will be performed following minimally invasive approach.
Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device.
Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #15/02 inserted 2mm short of working length for 60 seconds. ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland) till # X3 (Elnaghy et al. 2014). Each file will be used in one molar. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.
- Conditions
- Postoperative Pain
- Being tested
- coronal flaring, Non coronal flaring
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronal flaringProcedure or surgery
early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone
Non coronal flaringProcedure or surgery
No coronal flaring will be performed
| Study group | Role | What they receive |
|---|---|---|
| Early acoronal flaring | Experimental | In group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone Receives: Procedure: coronal flaring |
| Non coronal flaring | Active comparator | In group B no coronal flaring will be performed following minimally invasive approach. Receives: Procedure: Non coronal flaring |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Measured: after 4hours after treatment.
postoperative pain
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Measured: after 6hours after treatment.
postoperative pain
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Measured: after 12hours after treatment.
postoperative pain
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Measured: after 24hours after treatment.
postoperative pain
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Measured: after 48 hours after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Zagazig University
- Responsible party
- Principal investigator, Heba Elasfouri, Cairo University
- Investigators
- Heba A ElAsfouri, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169879
- Sponsor's protocol ID
- Endo 28-11-2021
- Acronym
- flaring
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capar ID, Arslan H, Akcay M, Ertas H. An in vitro comparison of apically extruded debris and instrumentation times with ProTaper Universal, ProTaper Next, Twisted File Adaptive, and HyFlex instruments. J Endod. 2014 Oct;40(10):1638-41. doi: 10.1016/j.joen.2014.04.004. Epub 2014 May 27.
PubMed 25260737
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early Coronal Flaring Upon Postoperative Pain Following Root Canal Treatment. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05169879
- Acronym / sponsor ID
- flaring / Endo 28-11-2021
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Zagazig University
- Study start
- Jan 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 27 Dec 2021 (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 clinical study is to evaluate the influence of early coronal flaring upon postoperative pain following root canal treatment in a single session approach.
Detailed description
All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.
Canals will be scouted using manual patency file in a watch winding maneuver. In group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. In group B no coronal flaring will be performed following minimally invasive approach.
Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device.
Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #15/02 inserted 2mm short of working length for 60 seconds. ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland) till # X3 (Elnaghy et al. 2014). Each file will be used in one molar. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early acoronal flaring | Experimental | Procedure: coronal flaringIn group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone |
| Non coronal flaring | Active comparator | Procedure: Non coronal flaringIn group B no coronal flaring will be performed following minimally invasive approach. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Patient age above 18-70 years old.
Key exclusion criteria (12 listed)
- 1. Necrotic molars
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 |
|---|---|---|
| coronal flaringearly coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone | Procedure or surgery | Early acoronal flaring |
| Non coronal flaringNo coronal flaring will be performed | Procedure or surgery | Non coronal flaring |
Primary outcome
postoperative pain
Time frame: after 4hours after treatment.
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain
Time frame: after 6hours after treatment.
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain
Time frame: after 12hours after treatment.
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain
Time frame: after 24hours after treatment.
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
postoperative pain
Time frame: after 48 hours after treatment.
The pain level will be measured using a validated pain scale known as the Verbal Analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Background: PubMed 25260737Capar ID, Arslan H, Akcay M, Ertas H. An in vitro comparison of apically extruded debris and instrumentation times with ProTaper Universal, ProTaper Next, Twisted File Adaptive, and HyFlex instruments. J Endod. 2014 Oct;40(10):1638-41. doi: 10.1016/j.joen.2014.04.004. Epub 2014 May 27.
- 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.
Heba A ElAsfouri study director
Cairo 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 coronal flaring and Non coronal flaring in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2021. 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 Egypt. 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?
Contact Heba A ElAsfouri (+201005276232, heba.elasfouri@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: after 4hours after treatment.). The study lists 5 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 NCT05169879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.