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

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119661
• Other study ID #: ENDO-CU-2012-7-15
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Device:
• Max-i-Probe
Using Max-i-Probe as endodontic needle during syringe irrigation
• NaviTip
Using NaviTip as endodontic needle during syringe irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain using a pain-measuring scale	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 4h after root canal treatment	4 hours
Primary	Postoperative pain using a pain-measuring scale	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 12h after root canal treatment	12 hours
Primary	Postoperative pain using a pain-measuring scale	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 24 h after root canal treatment	24 hours
Primary	Postoperative pain using a pain-measuring scale	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	48 hours