Anesthesia, LocalNCT03921190
Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique?
A study testing Local anesthesia in people with Anesthesia, Local and Pain Control, run by University of Jordan at 1 site in Jordan.
Trial summary
To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Pain Control
- What is being tested?
- Local anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 29 Apr 2019to 23 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (16 years old and older)
- Healthy (American Society of Anaesthesiologists (ASA) category I or II)
- A maxillary posterior tooth (excluding third molars) referred for root canal treatment and diagnosed with irreversible pulpitis and normal apical tissues
Who cannot join
- Psychological disorders
- Intraoral soft tissue abnormalities
- necrotic pulp with/ without apical pathology
- tenderness to palpation and/or percussion
- The use of analgesics in the preceding 12 hours before the appointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique? - a Clinical Study
To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques
Read the detailed description
Background: Local anesthesia is an essential part of dentistry. The most commonly used technique to anesthetise maxillary posterior teeth is buccal infiltration with a local anesthetic agent. The technique described in the literature focuses on the location of injection, the direction of the needle insertion in relation to the root apex, the direction of needle bevel in relation to the cortical bone plate, the size of needle and the type and amount of the local anesthetic agent used. However, there is no mention to whether the patient should open their mouth or maintain their teeth in intercuspation during the injection procedure.
Aims: This research aims to a) compare two techniques of injection (open and closed-mouth techniques) in terms of the discomfort experienced by patients during the injection procedure and b) evaluate the dentists' preference in performing either of the two techniques.
- Conditions
- Anesthesia, Local, Pain Control
- Being tested
- Local anesthesia
- Keywords
- Buccal infiltration anesthesia, Discomfort
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesiaProcedure or surgery
Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques
| Study group | Role | What they receive |
|---|---|---|
| Open-mouth | Active comparator | Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open Receives: Procedure: Local anesthesia |
| Closed-mouth | Experimental | Patients receiving MBIA using a closed-mouth technique Receives: Procedure: Local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Perception
Pain perception during local anesthesia injection on a standard 100mm visual analogue scale (VAS) where zero indicates no pain at all and 100 indicates intolerable pain/ worst imagined pain (scale attached in the protocol section). The average scores were calculated for each group and compared. Higher values indicated higher pain/ discomfort experienced during the injection procedure.
Measured: 5 minutes after receiving the injection
Secondary outcomes (2)
Dentist Perception of Visibility During Anesthesia Injection
Participating dentists were asked to rate the visibility of injection site and ease of cheek retraction during injection on a standard 100mm visual analogue scale where 100 indicates the best possible visibility/ easiest cheek retraction and 0 means no visibility at all/ most difficult cheek retraction. The mean scores were compared between the 2 groups using independent t-test.
Measured: 30-60 days
Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth
Number of dentists preferring each technique
Measured: 3-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start29 Apr 2019
- Primary completion20 Jun 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia, LocalStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad El-Ma'aita, University of Jordan
- Investigators
- Ahmad El-Ma'aita, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921190
- Sponsor's protocol ID
- 1012018/3686
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2019
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique? - a Clinical Study
- ClinicalTrials.gov ID
- NCT03921190
- Acronym / sponsor ID
- 1012018/3686
- Conditions
- Anesthesia, Local, Pain Control
- Keywords
- Buccal infiltration anesthesia, Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques
Detailed description
Background: Local anesthesia is an essential part of dentistry. The most commonly used technique to anesthetise maxillary posterior teeth is buccal infiltration with a local anesthetic agent. The technique described in the literature focuses on the location of injection, the direction of the needle insertion in relation to the root apex, the direction of needle bevel in relation to the cortical bone plate, the size of needle and the type and amount of the local anesthetic agent used. However, there is no mention to whether the patient should open their mouth or maintain their teeth in intercuspation during the injection procedure.
Aims: This research aims to a) compare two techniques of injection (open and closed-mouth techniques) in terms of the discomfort experienced by patients during the injection procedure and b) evaluate the dentists' preference in performing either of the two techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
| Arm | Type | Receives |
|---|---|---|
| Open-mouth | Active comparator | Procedure: Local anesthesiaPatients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open |
| Closed-mouth | Experimental | Procedure: Local anesthesiaPatients receiving MBIA using a closed-mouth technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (16 years old and older)
- Healthy (American Society of Anaesthesiologists (ASA) category I or II)
- A maxillary posterior tooth (excluding third molars) referred for root canal treatment and diagnosed with irreversible pulpitis and normal apical tissues
Key exclusion criteria (5 listed)
- Psychological disorders
- Intraoral soft tissue abnormalities
- necrotic pulp with/ without apical pathology
- tenderness to palpation and/or percussion
- The use of analgesics in the preceding 12 hours before the appointment.
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 |
|---|---|---|
| Local anesthesiaPatients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques | Procedure or surgery | Closed-mouth, Open-mouth |
Primary outcome
Patient Pain Perception
Time frame: 5 minutes after receiving the injection
Pain perception during local anesthesia injection on a standard 100mm visual analogue scale (VAS) where zero indicates no pain at all and 100 indicates intolerable pain/ worst imagined pain (scale attached in the protocol section). The average scores were calculated for each group and compared. Higher values indicated higher pain/ discomfort experienced during the injection procedure.
2 secondary outcomes
Dentist Perception of Visibility During Anesthesia Injection
Time frame: 30-60 days
Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth
Time frame: 3-60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anesthesia, Local
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
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.
Ahmad El-Ma'aita, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia in people with Anesthesia, Local and Pain Control, run by University of Jordan at 1 site in Jordan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jan 2021. 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 Jordan. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Pain Perception (time frame: 5 minutes after receiving the injection). 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 Jan 2021.