An interventional study of Chemomechanical preparation for root canals in Post Operative Pain and Inflammation, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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)
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.
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Exclusion Criteria:
Using trunatomy file for chemomechanical preparation for root canal of mandibular premolars
Procedure: Chemomechanical preparation for root canals
Using edgeendo x7 file for chemomechanical preparation for root canal of mandibular premolars
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
Also known as: Root canal treatment
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
Time frame: After 6 hours,24 hours, 48 hours and finally 72 hours
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
Time frame: Preoperatively ( after working length determination) and before obturation after 3days
Plan to share: Yes — Detailed statistical analysis plan
Supporting information: Sap
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Ain Shams University