Postoperative PainNCT05206214
Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain
A study testing Manual glide path and Mechanical glide path in people with Postoperative Pain, run by Cairo University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Manual glide path and Mechanical glide path
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient age above 18-70 years old.
- Both males and females will be included.
- All patients are in a good health without systemic condition.
- The offending tooth is a molar.
- The offending molar is indicated for root canal treatment.
- One molar for every patient.
- All patients will sign an informed consent.
Who cannot join
- 1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
- 2. The patient showing any clinical or radiographic evidence of periapical pathosis.
- 3. Patients received analgesics or systemic antibiotic prior to treatment.
- -.4 Immunocompromised patients.
- 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
- 6. History of cancer with radio or chemotherapy.
Show all 11Show fewer
- 7. Offending molar with mobility score ≥2.
- 8. Offending molar with pocket depth ≥6mm.
- 9. Immature molars.
- 10. Nonodontogenic pain.
- 11. Patients with more than one tooth requiring endodontic intervention.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds.
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). 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
- Manual glide path, Mechanical glide path
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual glide pathProcedure or surgery
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. . Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
Mechanical glide pathProcedure or surgery
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
| Study group | Role | What they receive |
|---|---|---|
| Manual glide path | Experimental | manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver Receives: Procedure: Manual glide path |
| mechanical glide path | Experimental | glide path will be established using rotary Ni-Ti files in a reciprocating maneuver Receives: Procedure: Mechanical glide path |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
postoperative pain after root canal treatment using VAS
Measured: after 4 hours after root canal treatment
postoperative pain
postoperative pain after root canal treatment using VAS
Measured: after 6hours after root canal treatment
postoperative pain
postoperative pain after root canal treatment using VAS
Measured: after 12hours after root canal treatment
postoperative pain
postoperative pain after root canal treatment using VAS
Measured: after 24hours after root canal treatment
postoperative pain
postoperative pain after root canal treatment using VAS
Measured: after 48 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study startJun 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 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
- NCT05206214
- Sponsor's protocol ID
- 26-12-2021
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu H, Peng C, Bai Y, Hu X, Wang L, Li C. Shaping ability of ProTaper Universal, WaveOne and ProTaper Next in simulated L-shaped and S-shaped root canals. BMC Oral Health. 2015 Mar 1;15:27. doi: 10.1186/s12903-015-0012-z.
PubMed 25886847
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05206214
- Acronym / sponsor ID
- 26-12-2021
- 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
- Jun 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Jan 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.
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds.
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.
In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). 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 |
|---|---|---|
| Manual glide path | Experimental | Procedure: Manual glide pathmanual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver |
| mechanical glide path | Experimental | Procedure: Mechanical glide pathglide path will be established using rotary Ni-Ti files in a reciprocating maneuver |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age above 18-70 years old.
- Both males and females will be included.
- All patients are in a good health without systemic condition.
- The offending tooth is a molar.
- The offending molar is indicated for root canal treatment.
Key exclusion criteria (11 listed)
- 1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
- 2. The patient showing any clinical or radiographic evidence of periapical pathosis.
- 3. Patients received analgesics or systemic antibiotic prior to treatment.
- -.4 Immunocompromised patients.
- 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
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 |
|---|---|---|
| Manual glide pathmanual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. . Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. | Procedure or surgery | Manual glide path |
| Mechanical glide pathglide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. | Procedure or surgery | mechanical glide path |
Primary outcome
postoperative pain
Time frame: after 4 hours after root canal treatment
postoperative pain after root canal treatment using VAS
postoperative pain
Time frame: after 6hours after root canal treatment
postoperative pain after root canal treatment using VAS
postoperative pain
Time frame: after 12hours after root canal treatment
postoperative pain after root canal treatment using VAS
postoperative pain
Time frame: after 24hours after root canal treatment
postoperative pain after root canal treatment using VAS
postoperative pain
Time frame: after 48 hours after root canal treatment
postoperative pain after root canal treatment using VAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Background: PubMed 25886847Wu H, Peng C, Bai Y, Hu X, Wang L, Li C. Shaping ability of ProTaper Universal, WaveOne and ProTaper Next in simulated L-shaped and S-shaped root canals. BMC Oral Health. 2015 Mar 1;15:27. doi: 10.1186/s12903-015-0012-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.
Heba A ElAsfouri study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Manual glide path and Mechanical glide path in people with Postoperative Pain, run by Cairo University.
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 11 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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, AssProfessor (+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 4 hours after root canal 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 NCT05206214, 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 25 Jan 2022.