Anesthesia, Local, Pain Control
Conditions
Keywords
Buccal infiltration anesthesia, Discomfort
Brief summary
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.
Interventions
PROCEDURELocal anesthesia
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
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Perception | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dentist Perception of Visibility During Anesthesia Injection | 30-60 days | 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. |
| Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth | 3-60 days | Number of dentists preferring each technique |
Countries
Jordan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-mouth Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open
Local anesthesia: 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 | 56 |
| Closed-mouth Patients receiving MBIA using a closed-mouth technique
Local anesthesia: 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 | 64 |
| Total | 120 |
Baseline characteristics
| Characteristic | Open-mouth | Closed-mouth | Total |
|---|---|---|---|
| Age, Continuous | 38.7 years STANDARD_DEVIATION 14.7 | 39.6 years STANDARD_DEVIATION 14.9 | 39.3 years STANDARD_DEVIATION 14.85 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 38 Participants | 69 Participants |
| Sex: Female, Male Male | 25 Participants | 26 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 64 |
| other Total, other adverse events | 0 / 56 | 0 / 64 |
| serious Total, serious adverse events | 0 / 56 | 0 / 64 |
Outcome results
Primary
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.
Time frame: 5 minutes after receiving the injection
Population: Study participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-mouth | Patient Pain Perception | 32.6 millimeters on a visual analogue scale | Standard Deviation 15.8 |
| Closed-mouth | Patient Pain Perception | 25 millimeters on a visual analogue scale | Standard Deviation 14 |
Secondary
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.
Time frame: 30-60 days
Population: Patients receiving maxillary buccal infiltration anesthesia
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open-mouth | Dentist Perception of Visibility During Anesthesia Injection | Visibility during injection | 68.1 millimeters on a visual analogue scale | Standard Deviation 17.1 |
| Open-mouth | Dentist Perception of Visibility During Anesthesia Injection | Ease of cheek retraction | 64.9 millimeters on a visual analogue scale | Standard Deviation 20.1 |
| Closed-mouth | Dentist Perception of Visibility During Anesthesia Injection | Visibility during injection | 82.6 millimeters on a visual analogue scale | Standard Deviation 14.3 |
| Closed-mouth | Dentist Perception of Visibility During Anesthesia Injection | Ease of cheek retraction | 83.2 millimeters on a visual analogue scale | Standard Deviation 12.7 |
Secondary
Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth
Number of dentists preferring each technique
Time frame: 3-60 days
Population: Practicing dentists performing local anesthesia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open-mouth | Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth | 3 Participants |
| Closed-mouth | Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth | 38 Participants |