Anesthetic Efficacy of X-tip Intraosseous Injection

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01214369
• Other study ID #: 88288
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2010
• Last updated: October 26, 2010
• Start date: October 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2010
• Source: Mashhad University of Medical Sciences
• Contact: Mina Zarei Binabaj, DDS,MSc
• Phone: 00985118829525
• Email: zareim[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Dentistry	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Heart rate monitoring	This record will be monitored by puls oximeter device	before block injection and after supplementary injection	No