Comparison Between the Vibringe and the Conventional Needle

NCT03551587 | Completed

• 1 other identifier: Vibringe_Postoperative_pain
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The Vibringe is the first endodontic sonic irrigation system that enables delivery and activation of the irrigation solution in the root canal, in only one step. The activation of the disinfectant by acoustic streaming, enriches and completes the irrigation procedure and improves the success rate of endodontic treatments. It has been shown that this system significantly improves debridement. It also improves the disruption of the smear layer and biofilm by activating irrigation solutions. As there are no previous studies comparing the Vibringe system with other irrigation techniques under clinical settings, in this regard, the aim of this study is to evaluate whether irrigation with Vibringe provides more or less benefit in terms of postoperative pain when compared with the conventional needle technique.

Conditions

Endodontic Inflammation

Outcome Measures

Primary Outcomes (4)

• pain intensity ( post operative pain )

  post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

  6 hours post- obturation.

• pain intensity ( post operative pain )

  post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

  12 hours post- obturation.

• pain intensity ( post operative pain )

  post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

  24 hours post- obturation.

• pain intensity ( post operative pain )

  post operative pain measured by Numeric Rating Scale (0-10) where; 0; No pain. 1-3; Mild Pain 4-6; Moderate Pain 7-10; Severe pain: "severe pain, analgesic had no effect in relieving the pain".

  48 hours post- obturation.

Study Arms (2)

Irrigant delivered by the Vibringe

EXPERIMENTAL

Experimental group: The irrigant will be delivered and sonically activated with the Vibringe system.

Device: Vibringe

Irrigation by Conventional needle

NO INTERVENTION

Control group: Irrigation procedures will br performed with a conventional method using conventional gauge 24 needle.

Interventions

Vibringe DEVICE

The Vibringe is the first endodontic sonic irrigation system that enables delivery and activation of the irrigation solution in the root canal, in only one step.

Irrigant delivered by the Vibringe

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 25-45 years old.
• Males or Females.
• Single rooted teeth with:
• Symptomatic irreversible pulpitis .
• Normal periapical radiographic appearance or slight widening in lamina dura.

You may not qualify if:

• Patients on medication for chronic pain.
• Patients having significant systemic disorders.
• Teeth that have :
• Vital pulp tissues.
• Swelling or fistulous tract
• Acute or chronic peri-apical abscess
• Greater than grade I mobility
• Pocket depth greater than 5mm
• No possible restorability
• Previous endodontic treatment.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Professor Heba El Far

  Cairo University

  STUDY DIRECTOR

• Faculty of Dentistry

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: November 28, 2017
• Primary Completion: January 27, 2019
• Study Completion: February 28, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Locations

EG (1)