AnesthesiaNCT01214369
Anesthetic Efficacy of X-tip Intraosseous Injection
A study testing Type of Supplementary Injection in people with Anesthesia, run by Mashhad University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Type of Supplementary Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Oct 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Mashhad, Razavi Khorasan Province, 91735
Ehsan Sharifi, postgratuate student, +989151116448, sharifie@mums.ac.ir
Mina Zarei, DDS,MSc
About this study
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
Read the 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)
- Conditions
- Anesthesia
- Being tested
- Type of Supplementary Injection
- Keywords
- intraosseous injection, X-tip, PDL injection, Supplementary Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of Supplementary InjectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| X-tip intraosseous injection | Active comparator | Not described Receives: Procedure: Type of Supplementary Injection |
| PDL injection | Active comparator | Not described Receives: Procedure: Type of Supplementary Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Heart rate monitoring
This record will be monitored by puls oximeter device
Measured: before block injection and after supplementary injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Jamileh Ghoddusi, DDS,MSc, Principal investigator, Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214369
- Sponsor's protocol ID
- 88288
- Status last verified
- Sep 2010
- First submitted
- 10 Sep 2010
- Last updated
- 27 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy of X-tip Intraosseous Injection Following Mandibular Nerve Block in Molars With Acute Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01214369
- Acronym / sponsor ID
- 88288
- Conditions
- Anesthesia
- Keywords
- intraosseous injection, X-tip, PDL injection, Supplementary Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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:
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-tip intraosseous injection | Active comparator | Procedure: Type of Supplementary Injection |
| PDL injection | Active comparator | Procedure: Type of Supplementary Injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of Supplementary InjectionPatients 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. | Procedure or surgery | PDL injection, X-tip intraosseous injection |
Primary outcome
Number of participant who will have the pain following X-tip or PDL as a supplementary injection
Time frame: 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.
1 secondary outcome
Heart rate monitoring
Time frame: before block injection and after supplementary injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamileh Ghoddusi, DDS,MSc principal investigator
Dental Research Center,Faculty of Dentistry, Mashhad University of Medical Sciences, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of Supplementary Injection in people with Anesthesia, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Zarei Binabaj, DDS,MSc (00985118829525, zareim@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant who will have the pain following X-tip or PDL as a supplementary injection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2010.