Clinical trial NCT05289973: Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain
Official title: Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontically Treated Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients having mandibular molars with necrotic pulp
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain
timeFrame: Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.
Secondary outcomes:
measure: Number of analgesics taken by the patient after endodontic treatment
timeFrame: up to 7 days post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Angie Ghoneim, PHD
role: STUDY_DIRECTOR
References:
citation: Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. doi: 10.1046/j.1365-2591.2000.00339.x.
citation: 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.
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. doi: 10.1016/S0099-2399(87)80004-3. No abstract available.