Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp
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
1 other identifier
interventional
56
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 17, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 21, 2022
November 1, 2022
10 months
November 2, 2022
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 72 hours after endodontic treatment
Secondary Outcomes (1)
Intra-canal bacterial reduction
Bacterial samples will be taken Immediately after root canal instrumentation.
Study Arms (4)
Root canal instrumentation EdgeFile X7 to size #35/0.06
EXPERIMENTALThe mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06
Root canal instrumentation EdgeFile X7 to size #45/0.04
EXPERIMENTALThe 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
EXPERIMENTALThe 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 COMPARATORThe mechanical preparation will be continued using EdgeFile X7 #35 .04
Interventions
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
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.
PMID: 34058250BACKGROUNDRodrigues 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.
PMID: 28483164BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nermeen Ibrahim, Master's
Misr University for Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer Assisstant
Study Record Dates
First Submitted
November 2, 2022
First Posted
November 17, 2022
Study Start
January 1, 2023
Primary Completion
November 1, 2023
Study Completion
December 1, 2023
Last Updated
November 21, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share