Clinical trial NCT04119661: Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles
Official title: Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain using a pain-measuring scale
timeFrame: 4 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 12 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 24 hours
measure: Postoperative pain using a pain-measuring scale
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Suzan Amin, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed El-Bayoumi, Professor
role: STUDY_CHAIR
References:
citation: Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
citation: Middha M, Sangwan P, Tewari S, Duhan J. Effect of continuous ultrasonic irrigation on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Int Endod J. 2017 Jun;50(6):522-530. doi: 10.1111/iej.12666. Epub 2016 Jun 28.