Effect of Removal of Intracanal Medication on Post Operative Pain

NCT ID: NCT04324086

Last Updated: 2020-03-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-10-01

Brief Summary

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Recruited patients with necrotic pulp after application of Calcium hydroxide are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

Detailed Description

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The investigator will recruit patients who are found eligible to the criteria, Calcium hydroxide will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Conditions

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Effects of the Elements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double

Study Groups

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XP-endo Finisher file

removal of calcium hydroxide intracanal medication with XP-endo Finisher file

Group Type EXPERIMENTAL

Calcium hydroxide with XP-endo Finisher file

Intervention Type DEVICE

XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of calcium hydroxide

Irrisafe Ultrasonic tip

removal of calcium hydroxide intracanal medication with passive ultrasonic irrigation

Group Type EXPERIMENTAL

Calcium hydroxide with Irrisafe Ultrasonic tip

Intervention Type DEVICE

passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in reemoval of calcium hydroxide

side vented needle

removal of calcium hydroxide intracanal medication with conventional syringe irrigation

Group Type ACTIVE_COMPARATOR

Calcium hydroxide with side vented needle

Intervention Type DEVICE

conventional syringe irrigation with side vented needle (prime Dent, India) in removal of calcium hydroxide

Interventions

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Calcium hydroxide with XP-endo Finisher file

XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of calcium hydroxide

Intervention Type DEVICE

Calcium hydroxide with Irrisafe Ultrasonic tip

passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in reemoval of calcium hydroxide

Intervention Type DEVICE

Calcium hydroxide with side vented needle

conventional syringe irrigation with side vented needle (prime Dent, India) in removal of calcium hydroxide

Intervention Type DEVICE

Other Intervention Names

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passive ultrasonic irrigation conventional syringe irrigation

Eligibility Criteria

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Inclusion Criteria

* Medically free patients.
* Patient's age between 20-50 years.
* Both sexes.
* Necrotic pulp as indicated by thermal or electric pulp testing.
* No history of previous endodontic treatment of the tooth.
* Enough crown structure for adequate isolation.

Exclusion Criteria

* Pregnancy or lactation
* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with abnormal anatomy or calcified canals.
* Teeth with caries below the bony level (non-restorable tooth).
* Immature teeth with open apices.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Nasr El-deen Abd El-gaffar

phD student - Endodontic Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral and dental medicine, Minia University

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shaimaa Nasr El-din Abd El-Ghaffar, PHD

Role: CONTACT

+0201020271788

Reham Hassan, Ass.prof

Role: CONTACT

01001542529

Facility Contacts

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Shaimaa Nasr El-deen, PHD

Role: primary

+0201020271788

References

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Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.

Reference Type BACKGROUND
PMID: 25598754 (View on PubMed)

Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.

Reference Type BACKGROUND
PMID: 23657409 (View on PubMed)

Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

Reference Type RESULT
PMID: 20647083 (View on PubMed)

Other Identifiers

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311

Identifier Type: -

Identifier Source: org_study_id

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