Anesthetic Efficacy of X-tip Intraosseous Injection

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT01214369

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Type of Supplementary Injection	N/A

Detailed Description

Randomization:
All patients will be randomly divided into two groups as follows:

X-tip intraosseous injection will be used as supplementary
PDL injection will be used as supplementary

Anesthetic evaluation:
For anesthetic evaluation we will use Visual Analog Scale (VAS)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Official Title:

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Nov 1, 2010

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Heart rate monitoring [before block injection and after supplementary injection]
This record will be monitored by puls oximeter device

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Mashhad	Khorasan Razavi	Iran, Islamic Republic of	91735

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01214369

Other Study ID Numbers:

88288

First Posted:

Oct 5, 2010

Last Update Posted:

Oct 27, 2010

Last Verified:

Sep 1, 2010

Keywords provided by , ,

intraosseous injection

X-tip

PDL injection

Supplementary Injection

Study Results

No Results Posted as of Oct 27, 2010