Anesthetic Efficacy of X-tip Intraosseous Injection

NCT ID: NCT01214369

Last Updated: 2010-10-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-01-31

Brief Summary

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* 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

Detailed Description

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* Randomization:

* All patients will be randomly divided into two groups as follows:

1. X-tip intraosseous injection will be used as supplementary
2. PDL injection will be used as supplementary
* Anesthetic evaluation:

* For anesthetic evaluation we will use Visual Analog Scale (VAS)

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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X-tip intraosseous injection

Group Type ACTIVE_COMPARATOR

Type of Supplementary Injection

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Type of Supplementary Injection

Intervention Type 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.

Interventions

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Type of Supplementary Injection

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Faculty of pharmacy, Mashhad University of Medical Sciences

Principal Investigators

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Jamileh Ghoddusi, DDS,MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Faculty of Dentistry

Mashhad, Khorasan Razavi, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mina Zarei Binabaj, DDS,MSc

Role: CONTACT

00985118829525

Facility Contacts

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Ehsan Sharifi, postgratuate student

Role: primary

+989151116448

Other Identifiers

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88288

Identifier Type: -

Identifier Source: org_study_id