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Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems (A Randomized Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06286995
Enrollment
20
Registered
2024-02-29
Start date
2023-10-14
Completion date
2024-02-14
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Post Operative Pain

Keywords

Post operative pain, Substance P, Apical periodontitis, Trunatomy file, Edgeendo x7 file

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.

Interventions

PROCEDUREChemomechanical preparation for root canals

After working length determination ,root canal preparation was made by two different NiTi File systems to both group ( the first group using Trunatomy file and the second one using edgeendo x7 file) and assessment of pain was made preoperatively and postoperatively and also apical fluid samples

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

A) Sequence generation: was done using random sequence number generated by computer software B) Allocation concealment Mechanism:folded,numbered papers were placed in tightly sealed envelopes containing patients' coding

Intervention model description

This study was designed to be randomized,single- blinded, single-center clinical trial

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of post operative pain using 10-cm visual analogue scale ( VAS)After 6 hours,24 hours, 48 hours and finally 72 hours10-cm visual analogue scale (VAS) questionnaire.each patient reported their level of pain as follow: 0 no pain,1-3 mild pain,4-6 moderate pain,7-9 severe pain and 10 the worst pain

Secondary

MeasureTime frameDescription
Level of inflammatory mediators substance P in apical fluid samplesPreoperatively ( after working length determination) and before obturation after 3daysSample were obtained by paper point size 25passing 2mm beyond the apex where they were soaked in the periapical interstitial fluid for 1minute .four mm from tip of paper point we're cut and dropped into 1,5ml Eppendorf tubes ( Swanscombe,UK) with 1ml of phosphate buffered saline,then restored at -80 to be measured by ELISA test

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026