Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

Not Applicable

• Conditions: Endodontically Treated Teeth
• Interventions: Device: TruNatomy Files; Device: HyFlex EDM Files

• Registration Number: NCT05289973
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Study Start: 2022-08-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TruNatomy Files	TruNatomy Files	Newly introduced endodontic file
Hyflex EDM	HyFlex EDM Files	Endodontic file

Primary Outcome Measures

Name	Time	Method
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain	Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.	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.

Secondary Outcome Measures

Name	Time	Method
Number of analgesics taken by the patient after endodontic treatment	up to 7 days post-operatively	Counting Number of analgesics taken by the patient after endodontic treatment