Necrotic PulpNCT05620147
Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp
A study testing Root canal instrumentation EdgeFile X7 to size #35/0.06, Root canal instrumentation EdgeFile X7 to size #45/0.04 and Root canal instrumentation EdgeFile X7 to size #45/0.06 in people with Necrotic Pulp, run by Cairo University.
Trial summary
The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Root canal instrumentation EdgeFile X7 to size #35/0.06, Root canal instrumentation EdgeFile X7 to size #45/0.04 and Root canal instrumentation EdgeFile X7 to size #45/0.06
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II.
- Patient's age ranges between 18 to 35 years with no sex predilection.
- Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp.
- Patients who can understand the Numerical Rating Scale (NRS).
- Patients able to sign informed consent.
Who cannot join
- Pregnant females.
- Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility.
- Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis).
- Patients have teeth that have been previously accessed.
- Teeth with extensive crown destruction by caries that will not permit rubber dam placement.
- Teeth associated with acute periapical abscess, swelling or a fistulous tract.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial
The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.
Read the detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).
- Conditions
- Necrotic Pulp
- Being tested
- Root canal instrumentation EdgeFile X7 to size #35/0.06, Root canal instrumentation EdgeFile X7 to size #45/0.04, Root canal instrumentation EdgeFile X7 to size #45/0.06, Root canal instrumentation EdgeFile X7 to size #35/0.04
- Keywords
- Apical enlargement, Postoperative pain, Intra-canal bacterial reduction, Preparation taper, EdgeFile X7
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal instrumentation EdgeFile X7 to size #35/0.06Other
Also called EdgeEndo
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Root canal instrumentation EdgeFile X7 to size #45/0.04Other
Also called EdgeEndo
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Root canal instrumentation EdgeFile X7 to size #45/0.06Other
Also called EdgeEndo
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Root canal instrumentation EdgeFile X7 to size #35/0.04Other
Also called EdgeEndo
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
| Study group | Role | What they receive |
|---|---|---|
| Root canal instrumentation EdgeFile X7 to size #35/0.06 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06 Receives: Other: Root canal instrumentation EdgeFile X7 to size #35/0.06 |
| Root canal instrumentation EdgeFile X7 to size #45/0.04 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04 Receives: Other: Root canal instrumentation EdgeFile X7 to size #45/0.04 |
| Root canal instrumentation EdgeFile X7 to size #45/0.06 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06 Receives: Other: Root canal instrumentation EdgeFile X7 to size #45/0.06 |
| Root canal instrumentation EdgeFile X7 to size #35/0.04 | Active comparator | The mechanical preparation will be continued using EdgeFile X7 #35 .04 Receives: Other: Root canal instrumentation EdgeFile X7 to size #35/0.04 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.
Measured: up to 72 hours after endodontic treatment
Secondary outcomes (1)
Intra-canal bacterial reduction
Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL)
Measured: Bacterial samples will be taken Immediately after root canal instrumentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen AwadAllah Abbas Ibrahim, Cairo University
- Investigators
- Nermeen Ibrahim, Master's, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620147
- Sponsor's protocol ID
- 2/11/2022
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fatima S, Kumar A, Andrabi SMUN, Mishra SK, Tewari RK. Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers on Postoperative Pain and Outcome of Primary Endodontic Treatment: A Prospective Randomized Clinical Trial. J Endod. 2021 Sep;47(9):1345-1351. doi: 10.1016/j.joen.2021.05.010. Epub 2021 May 29.
PubMed 34058250Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Orstavik D, Rocas IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5.
PubMed 28483164
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers of EdgeFile X7 on Postoperative Pain and Intra-canal Bacterial Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05620147
- Acronym / sponsor ID
- 2/11/2022
- Conditions
- Necrotic Pulp
- Keywords
- Apical enlargement, Postoperative pain, Intra-canal bacterial reduction, Preparation taper, EdgeFile X7
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 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.
The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.
Detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 4 groups: experimental groups of root canal instrumentation with EdgeFile X7 to size #35/0.06 or #45/0.04 or #45/0.06 or the comparator group to size #35/0.04. Intra-canal bacterial count will be measured using a culture technique. Bacterial samples will be taken before and after root canal instrumentation. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 400 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed at 6, 12, 24, 48 and 72 hours postoperatively using Numerical Rating Scale (NRS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Root canal instrumentation EdgeFile X7 to size #35/0.06 | Experimental | Other: Root canal instrumentation EdgeFile X7 to size #35/0.06The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06 |
| Root canal instrumentation EdgeFile X7 to size #45/0.04 | Experimental | Other: Root canal instrumentation EdgeFile X7 to size #45/0.04The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04 |
| Root canal instrumentation EdgeFile X7 to size #45/0.06 | Experimental | Other: Root canal instrumentation EdgeFile X7 to size #45/0.06The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06 |
| Root canal instrumentation EdgeFile X7 to size #35/0.04 | Active comparator | Other: Root canal instrumentation EdgeFile X7 to size #35/0.04The mechanical preparation will be continued using EdgeFile X7 #35 .04 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically healthy patients, American Society of Anesthesiologists (ASA) I and II.
- Patient's age ranges between 18 to 35 years with no sex predilection.
- Patients with single-rooted mandibular premolars with asymptomatic necrotic pulp.
- Patients who can understand the Numerical Rating Scale (NRS).
- Patients able to sign informed consent.
Key exclusion criteria (7 listed)
- Pregnant females.
- Mandibular premolars with periodontal pockets greater than 5 mm or greater than grade I mobility.
- Patients have a positive history of antibiotic use or analgesic use within the past week or required antibiotic premedication for dental treatment (such as prosthetic joint prophylaxis).
- Patients have teeth that have been previously accessed.
- Teeth with extensive crown destruction by caries that will not permit rubber dam placement.
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 instrumentation EdgeFile X7 to size #35/0.06Also: EdgeEndoInstrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm | Other | Root canal instrumentation EdgeFile X7 to size #35/0.06 |
| Root canal instrumentation EdgeFile X7 to size #45/0.04Also: EdgeEndoInstrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm | Other | Root canal instrumentation EdgeFile X7 to size #45/0.04 |
| Root canal instrumentation EdgeFile X7 to size #45/0.06Also: EdgeEndoInstrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm | Other | Root canal instrumentation EdgeFile X7 to size #45/0.06 |
| Root canal instrumentation EdgeFile X7 to size #35/0.04Also: EdgeEndoInstrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm | Other | Root canal instrumentation EdgeFile X7 to size #35/0.04 |
Primary outcome
Post-operative pain
Time frame: up to 72 hours after endodontic treatment
Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success.
1 secondary outcome
Intra-canal bacterial reduction
Time frame: Bacterial samples will be taken Immediately after root canal instrumentation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 34058250Fatima S, Kumar A, Andrabi SMUN, Mishra SK, Tewari RK. Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers on Postoperative Pain and Outcome of Primary Endodontic Treatment: A Prospective Randomized Clinical Trial. J Endod. 2021 Sep;47(9):1345-1351. doi: 10.1016/j.joen.2021.05.010. Epub 2021 May 29.
- Background: PubMed 28483164Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Orstavik D, Rocas IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5.
- 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.
Nermeen Ibrahim, Master's principal investigator
Misr University for Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Root canal instrumentation EdgeFile X7 to size #35/0.06, Root canal instrumentation EdgeFile X7 to size #45/0.04 and Root canal instrumentation EdgeFile X7 to size #45/0.06 in people with Necrotic Pulp, 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 5 inclusion and 7 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 21 Nov 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 Nermeen Ibrahim, Master's (01114323345 ext. 002, nermin.awadallah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: up to 72 hours after endodontic treatment). 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 NCT05620147, which also lists 2 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 21 Nov 2022.