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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open-mouth Closed-mouth
Hide 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
Arm/Group Title Open-mouth Closed-mouth Total
Hide 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
Hide 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.
1.Primary Outcome
Title Patient Pain Perception
Hide 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
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Hide Analysis Population Description
Study participants
Arm/Group Title Open-mouth Closed-mouth
Hide 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
Hide 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
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Hide Analysis Population Description
Patients receiving maxillary buccal infiltration anesthesia
Arm/Group Title Open-mouth Closed-mouth
Hide 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
Hide Description Number of dentists preferring each technique
Time Frame 3-60 days
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Hide Analysis Population Description
Practicing dentists performing local anesthesia
Arm/Group Title Open-mouth Closed-mouth
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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%
Time Frame Up to 1 hour after injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-mouth Closed-mouth
Hide 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%) 
Hide Serious Adverse Events
Open-mouth Closed-mouth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/64 (0.00%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Ahmad El-Ma'aita
Organization: University of Jordan
Phone: +9625355000
EMail: a.maaita@ju.edu.jo
Layout table for additonal information
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