Clinical trial NCT06286995: Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems
Official title: Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Inflammation
Keywords: Post operative pain
Substance P
Apical periodontitis
Trunatomy file
Edgeendo x7 file
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed to be randomized,single- blinded, single-center clinical trial
Primary purpose: TREATMENT

Brief summary: The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS)

Detailed description: Patients : 20 patients with symptomatic apical periodontitis related to mandibular premolars were selected.after proper anathesia, Access cavity was ppreformed.The working length measured using apex locator.chemomechanical preparation was done .for trunatomy file group ,using file sequence according to manufacture's instructions until medium one .for edgeendo group ,using file sequence also according to manufacture's instructions until file size 35 taper4.Apical fluid samples was collected by paper point from the both preoperatively and before obturation and also pain was assessed pre and post opertively.finally,the root canal were filled by gutta-percha and resin based sealer.the access cavity was restored by glass ionomer restoration.

Eligibility criteria: Inclusion Criteria:

* clinical diagnoses of apical periodontitis related to single-rooted mandibular premolars
* no evidence of excessive mobility

Exclusion Criteria:

* presence of any systemic disease or allergic reaction
* Incompletely formed root
* Previously Endodontically treated teeth

Primary outcomes:
measure: Level of post operative pain using 10-cm visual analogue scale ( VAS)
timeFrame: After 6 hours,24 hours, 48 hours and finally 72 hours
Secondary outcomes:
measure: Level of inflammatory mediators substance P in apical fluid samples
timeFrame: Preoperatively ( after working length determination) and before obturation after 3days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Faculty of dentistry, Ain shams university
name: Maram F Obeid, Professor
role: STUDY_DIRECTOR
References:
citation: Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
citation: Valliappan CT, Rahul B, Gabriel EM, Sherwood IA, Gutmann JL, Amaechi BT, Burhanuddin Mohammed OF. Evaluation of postoperative pain with new heat-treated rotary and reciprocating nickel-titanium files: A randomized controlled clinical trial. J Conserv Dent. 2023 Mar-Apr;26(2):170-175. doi: 10.4103/jcd.jcd_566_22. Epub 2023 Mar 16.