Anesthetic Efficacy of X-tip Intraosseous Injection

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Mashhad University of Medical Sciences.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01214369

First received: September 10, 2010

Last updated: October 26, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2010

Last Updated Date

October 26, 2010

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of participant who will have the pain following X-tip or PDL as a supplementary injection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01214369 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Heart rate monitoring [ Time Frame: before block injection and after supplementary injection ] [ Designated as safety issue: No ]

This record will be monitored by puls oximeter device

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Anesthetic Efficacy of X-tip Intraosseous Injection

Official Title ^ICMJE

Anesthetic Efficacy of X-tip Intraosseous Injection Following Mandibular Nerve Block in Molars With Acute Irreversible Pulpitis

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

Detailed Description

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)

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Anesthesia

Intervention ^ICMJE

Procedure: 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.

Study Arm (s)

Active Comparator: X-tip intraosseous injection
Intervention: Procedure: Type of Supplementary Injection
Active Comparator: PDL injection
Intervention: Procedure: Type of Supplementary Injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Mina Zarei Binabaj, DDS,MSc

00985118829525

zareim@mums.ac.ir

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01214369

Other Study ID Numbers ^ICMJE

88288

Has Data Monitoring Committee

Yes

Responsible Party

Professor Mohammad Ramezani, Faculty of pharmacy, Mashhad University of Medical Sciences

Study Sponsor ^ICMJE

Mashhad University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jamileh Ghoddusi, DDS,MSc

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

Information Provided By

Mashhad University of Medical Sciences

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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