Effect of Removal of Intracanal Medication on Post Operative Pain

Effects of the Elements Clinical Trial

Official title:

Post Operative Pain After Removal of Calcium Hydroxide With Different Activation Techniques

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04324086
• Other study ID #: 311
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2020
• Source: Minia University
• Contact: Shaimaa Nasr El-din Abd El-Ghaffar, PHD
• Phone: +0201020271788
• Email: dr_shimes[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effects of the Elements
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Oral and dental medicine, Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in post operative pain (Visual Analogue Scale)	Numerical (0-10)	Intrappointment at 4,24,48,72 and 96 hours