Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

Endodontically Treated Teeth Clinical Trial

— TRN  

Official title:

Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05289973
• Other study ID #: TRN in postoperative pain
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: Nora El Khater, B.D.S
• Phone: 02-01063918844
• Email: nora.khater[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.

Description:

Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: February 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age between 25 - 45 years old.

2. Males or Females.

3. Mandibular molar teeth with:

• No pain.
• No response to pulp testing.
• Radiographic appearance with or without a periapical radiolucency.

Exclusion Criteria:

1. Patients with pre-operative pain.

2. Patients having significant systemic disorders.

3. Patients who are allergic to non-steroidal anti-inflammatory drugs.

4. Patients with two or more adjacent teeth requiring root canal therapy.

5. Teeth that have:

• Vital pulp tissues.
• Association with swelling or fistulous tract.
• Acute or chronic peri-apical abscess.
• Greater than grade I mobility.
• Pocket depth greater than 5mm.
• No possible restorability.
• Previous endodontic treatment.

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Pain, Postoperative
• Tooth, Nonvital

Intervention

Device:
• TruNatomy Files
Newly introduced endodontic file with high flexibility.
• HyFlex EDM Files
Endodontic files

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12. — View Citation

Ruiz-Hubard EE, Gutmann JL, Wagner MJ. A quantitative assessment of canal debris forced periapically during root canal instrumentation using two different techniques. J Endod. 1987 Dec;13(12):554-8. — View Citation

Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain	The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome.	Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.
Secondary	Number of analgesics taken by the patient after endodontic treatment	Counting Number of analgesics taken by the patient after endodontic treatment	up to 7 days post-operatively