Effect of Instrumentation Systems and Sealers on Postoperative Pain

ConditionIrriversible Pulpitis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorEuropean University of Lefke

About this trial

The goal of this randomized clinical trial is to evaluate whether different root canal preparation systems and sealer types affect postoperative pain after root canal treatment in adult patients (18-60 years) with asymptomatic irreversible pulpitis in mandibular premolars.

The main questions it aims to answer are:

Do different instrumentation systems (TruNatomy vs ProTaper Gold) influence postoperative pain levels? Do different sealer types (AH Plus vs TotalFill BC) affect postoperative pain and analgesic consumption? Researchers will compare TruNatomy and ProTaper Gold systems combined with AH Plus or TotalFill BC sealers to determine their effect on postoperative pain.

Participants will:

Undergo single-visit root canal treatment using one of the assigned file system and sealer combinations Record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals (6, 12, 24, 48, 72 hours, and 7 days) Take ibuprofen only if needed and record analgesic intake Attend a follow-up visit on the 7th day

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Asymptomatic teeth with delayed positive response to thermal and electric pulp testing

Vital teeth with signs of irreversible pulpitis

Mature mandibular first or second premolars

Periodontally healthy teeth

Disqualifiers

Patients with systemic conditions (e.g., diabetes, immunocompromised status, pregnancy)

Antibiotic use within the past month

Use of analgesics within 7 days prior to treatment

Known allergy to materials used

Trial design

Design model

Factorial

Treatments tested in this trial

TruNatomy
Device
Rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping with minimally invasive design. Instrumentation performed according to manufacturer instructions.
ProTaper Gold
Device
Heat-treated rotary nickel-titanium (NiTi) endodontic file system used for root canal shaping following manufacturer-recommended protocol.
AH Plus
Other intervention
Epoxy resin-based root canal sealer used for obturation with gutta-percha using a single-cone technique.
TotalFill BC
Other intervention
Calcium silicate-based bioceramic root canal sealer used for obturation with gutta-percha using a single-cone technique.

Treatment groups

144 Participants

are divided into 4 treatment groups

Group A: TruNatomy + AH PlusExperimental treatment 2 interventions

Group B: TruNatomy + TotalFill BCExperimental treatment 2 interventions

Group C: ProTaper Gold + AH PlusExperimental treatment 2 interventions

Group D: ProTaper Gold + TotalFill BCExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Postoperative Pain Intensity (Numerical Rating Scale)

Postoperative pain will be assessed using a Numerical Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain. Patients will record pain levels at 6, 12, 24, 48, and 72 hours, and on day 7 following root canal treatment.

Time frame

6, 12, 24, 48, 72 hours and 7 days post-treatment

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European University of Lefke

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: