Clinical trial NCT05620147: Effect of Apical Enlargement to Different Preparation Sizes and Tapers on Pain and Bacterial Reduction in Necrotic Pulp
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotic Pulp
Keywords: Apical enlargement
Postoperative pain
Intra-canal bacterial reduction
Preparation taper
EdgeFile X7
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Post-operative pain
timeFrame: up to 72 hours after endodontic treatment
Secondary outcomes:
measure: Intra-canal bacterial reduction
timeFrame: Bacterial samples will be taken Immediately after root canal instrumentation.
Other outcomes:
Locations:
Study officials:
affiliation: Misr University for Science and Technology
name: Nermeen Ibrahim, Master's
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rodrigues 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.