Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique?

• ClinicalTrials.gov Identifier: NCT03921190
• Recruitment Status: Completed
• First Posted: April 19, 2019
• Results First Posted: January 27, 2021
• Last Update Posted: January 27, 2021
• Sponsor: University of Jordan
• Information provided by (Responsible Party): Ahmad El-Ma'aita, University of Jordan

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Conditions: Anesthesia, Local; Pain Control
• Intervention: Procedure: Local anesthesia
• Enrollment: 120

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Open-mouth	Closed-mouth
Arm/Group Description	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	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
Period Title: Overall Study
Started	56	64
Completed	56	64
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Open-mouth	Closed-mouth	Total
Arm/Group Description		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	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	Total of all reporting groups
Overall Number of Baseline Participants		56	64	120
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	56 participants	64 participants	120 participants
		38.7 (14.7)	39.6 (14.9)	39.3 (14.85)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	64 participants	120 participants
	Female	31 55.4%	38 59.4%	69 57.5%
	Male	25 44.6%	26 40.6%	51 42.5%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.

Outcome Measures

1. Primary Outcome

Title	Patient Pain Perception
Description	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

Outcome Measure Data

Analysis Population Description

Study participants

Arm/Group Title	Open-mouth	Closed-mouth
Arm/Group Description:	Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Patients receiving MBIA using a closed-mouth technique
Overall Number of Participants Analyzed	56	64
Mean (Standard Deviation); Unit of Measure: millimeters on a visual analogue scale
	32.6 (15.8)	25 (14)

2. Secondary Outcome

Title	Dentist Perception of Visibility During Anesthesia Injection
Description	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

Outcome Measure Data

Analysis Population Description

Patients receiving maxillary buccal infiltration anesthesia

Arm/Group Title	Open-mouth	Closed-mouth
Arm/Group Description:	Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Patients receiving MBIA using a closed-mouth technique
Overall Number of Participants Analyzed	233	236
Mean (Standard Deviation); Unit of Measure: millimeters on a visual analogue scale
Visibility during injection	68.1 (17.1)	82.6 (14.3)
Ease of cheek retraction	64.9 (20.1)	83.2 (12.7)

3. Secondary Outcome

Title	Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth
Description	Number of dentists preferring each technique
Time Frame	3-60 days

Outcome Measure Data

Analysis Population Description

Practicing dentists performing local anesthesia

Arm/Group Title	Open-mouth	Closed-mouth
Arm/Group Description:	Number of dentists who preferred the open-mouth technique for maxillary buccal infiltration anesthesia	Number of dentists who preferred the closed-mouth technique for maxillary buccal infiltration anesthesia
Overall Number of Participants Analyzed	48	48
Measure Type: Count of Participants; Unit of Measure: Participants
	3 6.3%	38 79.2%

Adverse Events

Time Frame	Up to 1 hour after injection
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Open-mouth	Closed-mouth
Arm/Group Description	Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Patients receiving MBIA using a closed-mouth technique
All-Cause Mortality
	Open-mouth	Closed-mouth
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/56 (0.00%)	0/64 (0.00%)
Serious Adverse Events
	Open-mouth	Closed-mouth
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/56 (0.00%)	0/64 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Open-mouth	Closed-mouth
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/56 (0.00%)	0/64 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Ahmad El-Ma'aita
• Organization: University of Jordan
• Phone: +9625355000
• EMail: a.maaita@ju.edu.jo

• Responsible Party: Ahmad El-Ma'aita, University of Jordan
• ClinicalTrials.gov Identifier: NCT03921190
• Other Study ID Numbers: 1012018/3686
• First Submitted: March 30, 2019
• First Posted: April 19, 2019
• Results First Submitted: December 6, 2020
• Results First Posted: January 27, 2021
• Last Update Posted: January 27, 2021