Post-operative Pain Following Glide Path Preparation Using Rotary Neoniti GPS File and Manual K-files

NCT ID: NCT04559438

Last Updated: 2023-02-06

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-04-01

Brief Summary

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The aim of this study is to clinically compare the incidence of post-operative pain after using rotary glide path file (Neoniti GPS), on post-operative pain when compared to manual glide path preparation in lower molars with asymptomatic non-vital pulp.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Rotary Neoniti GPS

Glide path preparation using Rotary Neoniti GPS file (Neolix, châtres-la-Forêt, France).

Group Type EXPERIMENTAL

Rotary Neoniti GPS file

Intervention Type OTHER

Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.

Stainless steel K-files

Glide path preparation using manual stainless steel K-files #10, #15 (Dentsply Maillefer, Ballaigues, Switzerland).

Group Type ACTIVE_COMPARATOR

Manual stainless steel K-files

Intervention Type OTHER

Glide path preparation will be done by hand instrumentation using K-files #10 and 15.

Interventions

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Rotary Neoniti GPS file

Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.

Intervention Type OTHER

Manual stainless steel K-files

Glide path preparation will be done by hand instrumentation using K-files #10 and 15.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Systemically healthy patients (ASA I or II)
2. Lower permanent molar teeth with:

Asymptomatic non-vital pulps, No response of pulp tissue to cold pulp tester (ethyl chloride spray), with or without periapical lesions.

Exclusion Criteria

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Patients with two or more adjacent teeth requiring endodontic treatment.
4. TMJ problems, bruxism, clenching or traumatic occlusion.
5. Inability to perceive the given instructions.
6. Teeth with:

Vital pulp tissues. Association with swelling. Acute periapical abscess. Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Engy Abdel Nour Atallah

Principal investigator, Resident at faculty of dentistry, Cairo University.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba ElFar, Professor

Role: STUDY_CHAIR

Cairo University (Endodontics Department)

Dina Morsy, Lecturer

Role: STUDY_DIRECTOR

Cairo University (Endodontics Department)

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Pasqualini D, Mollo L, Scotti N, Cantatore G, Castellucci A, Migliaretti G, Berutti E. Postoperative pain after manual and mechanical glide path: a randomized clinical trial. J Endod. 2012 Jan;38(1):32-6. doi: 10.1016/j.joen.2011.09.017. Epub 2011 Oct 27.

Reference Type BACKGROUND
PMID: 22152616 (View on PubMed)

Keskin C, Sivas Yilmaz O, Inan U, Ozdemir O. Postoperative pain after glide path preparation using manual, reciprocating and continuous rotary instruments: a randomized clinical trial. Int Endod J. 2019 May;52(5):579-587. doi: 10.1111/iej.13053. Epub 2018 Dec 31.

Reference Type BACKGROUND
PMID: 30536837 (View on PubMed)

West JD. The endodontic Glidepath: "Secret to rotary safety". Dent Today. 2010 Sep;29(9):86, 88, 90-3.

Reference Type BACKGROUND
PMID: 20973422 (View on PubMed)

Other Identifiers

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ENDO 3-3-5

Identifier Type: -

Identifier Source: org_study_id

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