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To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-mouth | Active Comparator | Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open |
|
| Closed-mouth | Experimental | Patients receiving MBIA using a closed-mouth technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthesia | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes after receiving the injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad El-Ma'aita, PhD | University of Jordan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University Hospital | Amman | Select One | 11831 | Jordan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study participants | Posted | Mean | Standard Deviation | millimeters on a visual analogue scale | 5 minutes after receiving the injection |
|
Up to 1 hour after injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-mouth | Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmad El-Ma'aita | University of Jordan | +9625355000 | a.maaita@ju.edu.jo |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | Jan 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
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| 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 | 3-60 days |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients receiving MBIA using a closed-mouth technique |
|
|
| 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. | Patients receiving maxillary buccal infiltration anesthesia | Posted | Mean | Standard Deviation | millimeters on a visual analogue scale | 30-60 days |
|
|
|
| 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 | Practicing dentists performing local anesthesia | Posted | Count of Participants | Participants | 3-60 days |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Closed-mouth | Patients receiving MBIA using a closed-mouth technique | 0 | 64 | 0 | 64 | 0 | 64 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |