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
Recruitment status was Recruiting
Sponsor:
Mashhad University of Medical Sciences
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
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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:
- 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)
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
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 June 17, 2013