Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Device: Max-i-Probe; Device: NaviTip

• Registration Number: NCT04119661
• Lead Sponsor: Cairo University

Brief Summary

The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.

Detailed Description

The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-10
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-06
• Last Update Submitted: 2019-10-06
• Study First Posted: 2019-10-08
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age: 16-65 year old.
2. Medically free.
3. Mandibular posterior teeth with symptomatic irreversible pulpitis.
4. No sex predilection

Exclusion Criteria

1. Pregnant females.
2. History of allergy to any medication used in the study.
3. Preoperative premedication less than 6 hours before procedure.
4. Cracked teeth and teeth with badly-decayed crowns.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Max-i-Probe	Max-i-Probe	-
NaviTip	NaviTip	-

Primary Outcome Measures

Name	Time	Method
Postoperative pain using a pain-measuring scale	48 hours	Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48h after root canal treatment