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Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems

NCT ID: NCT06286995

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-14

Study Completion Date

2024-02-14

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Post Operative Pain Inflammation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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

Study Groups

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Trunatomy file group

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

Group Type ACTIVE_COMPARATOR

Chemomechanical preparation for root canals

Intervention Type 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

Edgeendo x7 file group

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

Group Type ACTIVE_COMPARATOR

Chemomechanical preparation for root canals

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Root canal treatment

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Essam Badr El-din, Bachelor

Bachelor degree in Dental Medicine and Surgery,May 2017

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maram F Obeid, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry, Ain shams university

Locations

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Ain Shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 21092809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37205884 (View on PubMed)

Related Links

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http://dsu.journals.ekb.eg/article_192084.html

Worked on inflammatory mediators in similar matter

Other Identifiers

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6280

Identifier Type: -

Identifier Source: org_study_id