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
  Purpose
  • 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

Condition Intervention
Anesthesia
Procedure: Type of Supplementary Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Anesthetic Efficacy of X-tip Intraosseous Injection Following Mandibular Nerve Block in Molars With Acute Irreversible Pulpitis

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: X-tip intraosseous injection 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.
Active Comparator: PDL injection 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.

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)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214369

Contacts
Contact: Mina Zarei Binabaj, DDS,MSc 00985118829525 zareim@mums.ac.ir

Locations
Iran, Islamic Republic of
Faculty of Dentistry Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Contact: Ehsan Sharifi, postgratuate student    +989151116448    sharifie@mums.ac.ir   
Sub-Investigator: Mina Zarei, DDS,MSc         
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: Jamileh Ghoddusi, DDS,MSc Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran
  More Information

No publications provided

Responsible Party: Professor Mohammad Ramezani, Faculty of pharmacy, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01214369     History of Changes
Other Study ID Numbers: 88288
Study First Received: September 10, 2010
Last Updated: October 26, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Mashhad University of Medical Sciences:
intraosseous injection
X-tip
PDL injection
Supplementary Injection

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014