Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

NCT06286995 | Completed

• 1 other identifier: 6280
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Post Operative Pain; Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Level of post operative pain using 10-cm visual analogue scale ( VAS)

  10-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

  After 6 hours,24 hours, 48 hours and finally 72 hours

Secondary Outcomes (1)

• Level of inflammatory mediators substance P in apical fluid samples

  Preoperatively ( after working length determination) and before obturation after 3days

Study Arms (2)

Trunatomy file group

ACTIVE COMPARATOR

Using trunatomy file for chemomechanical preparation for root canal of mandibular premolars

Procedure: Chemomechanical preparation for root canals

Edgeendo x7 file group

ACTIVE COMPARATOR

Using edgeendo x7 file for chemomechanical preparation for root canal of mandibular premolars

Procedure: Chemomechanical preparation for root canals

Interventions

Chemomechanical preparation for root canals PROCEDURE

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

Also known as: Root canal treatment

Edgeendo x7 file group; Trunatomy file group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 21092809 BACKGROUND

• 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.

  PMID: 37205884 BACKGROUND

Related Links

• Worked on inflammatory mediators in similar matter

MeSH Terms

Conditions

Pain, Postoperative; Inflammation; Periapical Periodontitis

Interventions

Root Canal Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Maram F Obeid, Professor

  Faculty of dentistry, Ain shams university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor degree in Dental Medicine and Surgery,May 2017

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

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: February 29, 2024
• Study Start: October 14, 2023
• Primary Completion: January 29, 2024
• Study Completion: February 14, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2025, available for a year
• Access Criteria: Review the purpose of request

Locations

EG (1)