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

NCT ID: NCT04119661

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Max-i-Probe

Group Type EXPERIMENTAL

Max-i-Probe

Intervention Type DEVICE

Using Max-i-Probe as endodontic needle during syringe irrigation

NaviTip

Group Type ACTIVE_COMPARATOR

NaviTip

Intervention Type DEVICE

Using NaviTip as endodontic needle during syringe irrigation

Interventions

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Max-i-Probe

Using Max-i-Probe as endodontic needle during syringe irrigation

Intervention Type DEVICE

NaviTip

Using NaviTip as endodontic needle during syringe irrigation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Suzan AW Amin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzan Amin, Professor

Role: STUDY_DIRECTOR

Cairo University

Mohamed El-Bayoumi, Professor

Role: STUDY_CHAIR

Cairo University

References

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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.

Reference Type BACKGROUND
PMID: 20647083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27248848 (View on PubMed)

Other Identifiers

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ENDO-CU-2012-7-15

Identifier Type: -

Identifier Source: org_study_id

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