Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06286995
• Other study ID #: 6280
• Status: Completed
• Phase: N/A
• Start date: October 14, 2023
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 14, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Chemomechanical 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

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Level of inflammatory mediators substance P in apical fluid samples	Sample 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	Preoperatively ( after working length determination) and before obturation after 3days

External Links

•   Worked on inflammatory mediators in similar matter