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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trunatomy file group | Active Comparator | Using trunatomy file for chemomechanical preparation for root canal of mandibular premolars |
|
| Edgeendo x7 file group | Active Comparator | Using edgeendo x7 file for chemomechanical preparation for root canal of mandibular premolars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maram F Obeid, Professor | Faculty of dentistry, Ain shams university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21092809 | Background | 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. | |
| 37205884 |
| Label | URL |
|---|---|
| Worked on inflammatory mediators in similar matter | View source |
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Detailed statistical analysis plan
2025, available for a year
Review the purpose of request
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007249 | Inflammation |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D012390 | Root Canal Therapy |
| ID | Term |
|---|---|
| D004708 | Endodontics |
| D003813 | Dentistry |
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This study was designed to be randomized,single- blinded, single-center clinical trial
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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
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|
| 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |