Anesthetic Efficacy of X-tip Intraosseous Injection

Not Applicable

• Conditions: Anesthesia
• Interventions: Procedure: Type of Supplementary Injection

• Registration Number: NCT01214369
• Lead Sponsor: Mashhad University of Medical Sciences

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 Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-10
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27
• Primary Completion: 2010-11
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-tip intraosseous injection	Type of Supplementary Injection	-
PDL injection	Type of Supplementary Injection	-

Primary Outcome Measures

Name	Time	Method
Number of participant who will have the pain following X-tip or PDL as a supplementary injection	6 months	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

Name	Time	Method
Heart rate monitoring	before block injection and after supplementary injection	This record will be monitored by puls oximeter device

Trial Locations

Locations (1)

Faculty of Dentistry; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of