Anesthetic Efficacy of X-tip Intraosseous Injection

NCT01214369 | Unknown DMC

• 1 other identifier: 88288
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

• Hypothesis:
• X-tip intraosseous is an effective supplementary injection in mandibular hot teeth as well as Periodontal Ligament (PDL) injection
• Purposes:
• Comparing the anesthetic efficacy of X-tip intraosseous and PDL injection in mandibular hot teeth which had not been anesthetized after 3.6 ml Infra Alveolar Nerve Block
• Methods and Materials:
• forty patients with mandibular hot molar or second premolar which had not been anesthetized after 3.6 ml inferior alveolar nerve block injection will be selected for this study

Conditions

Anesthesia

Keywords

intraosseous injection; X-tip; PDL injection; Supplementary Injection

Outcome Measures

Primary Outcomes (1)

• Number of participant who will have the pain following X-tip or PDL as a supplementary injection

  All particiapant will be asked to show their pain degree on VAS for evaluation the efficacy of injections as a supplementary for anesthetising the teeth before and after the supplementary injection.

  6 months

Secondary Outcomes (1)

• Heart rate monitoring

  before block injection and after supplementary injection

Study Arms (2)

X-tip intraosseous injection

ACTIVE COMPARATOR

Procedure: Type of Supplementary Injection

PDL injection

ACTIVE COMPARATOR

Procedure: Type of Supplementary Injection

Interventions

Type of Supplementary Injection PROCEDURE

Patients will be selected from a group who were not anesthetized following 3.6 ml block injection. Half of the randomly selected patients will receive X-tip intraosseous injection and half will receive PDL injection as a supplementary for completing the anesthesia in selected hot mandibular molar teeth.

PDL injection; X-tip intraosseous injection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mandibular Molars and second premolars with Acute Irreversible Pulpitis
• None of the teeth selected should have been anesthetized following 3.6 ml Lidocaine block injection

You may not qualify if:

• Unhealthy patients
• Teeth which were anesthetized following 3.6 ml nerve block injection
• Patients who did not have any signs of lip anesthesia following 3.6 ml injection

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Faculty of Dentistry

Mashhad, Khorasan Razavi, 91735, Iran

RECRUITING

Study Officials

• Jamileh Ghoddusi, DDS,MSc

  Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina Zarei Binabaj, DDS,MSc

CONTACT

00985118829525; zareim@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: October 5, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: October 27, 2010

Record last verified: 2010-09

Locations

IR (1)