Brief Summary

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

- 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

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
• Study Primary Completion Date: November 2010

Detailed Clinical Trial 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)

Interventions Used in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: X-tip intraosseous injection
• Active Comparator: PDL injection

Outcome Measures for this Clinical Trial

Primary Measures

• Number of participant who will have the pain following X-tip or PDL as a supplementary injection
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Heart rate monitoring
  • Time Frame: before block injection and after supplementary injection
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Mashhad University of Medical Sciences
• Provider of Information About this Clinical Study
  • Professor Mohammad Ramezani, Faculty of pharmacy, Mashhad University of Medical Sciences
• Overall Official(s)
  • Jamileh Ghoddusi, DDS,MSc, Principal Investigator, Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran
• Overall Contact(s)
  • Mina Zarei Binabaj, DDS,MSc, 00985118829525, zareim@mums.ac.ir