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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

Tracking Information
First Submitted Date  ICMJE March 30, 2019
First Posted Date  ICMJE April 19, 2019
Results First Submitted Date  ICMJE December 6, 2020
Results First Posted Date  ICMJE January 27, 2021
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE April 29, 2019
Actual Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)		 Patient perception [ Time Frame: 30-60 days ]
Patient perception of pain/ discomfort during injection will be recorded on a standard 100mm visual analogue scale where 100 is the worst imaginable pain and 0 is no pain at all. The patient's reported value will be registered as a numerical value and the means for the two groups will be compared to detect any statistical difference
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
  • Dentist Perception of Visibility During Anesthesia Injection [ Time Frame: 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 [ Time Frame: 3-60 days ]
    Number of dentists preferring each technique
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)		 Dentist perception [ Time Frame: 30-60 days ]
Particiapating dentists will be asked to rate the vibility of injection site and ease of cheek retraction on a standard 100mm visual analogue scale where 100 indicates the best possible visibility/ ease of cheek retraction and 0 means no visibility at all/ impossible cheek retraction. Finally the dentists will be asked to register their own preference of performing either of the two techniques (if any)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique?
Official Title  ICMJE Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique? - a Clinical Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Anesthesia, Local
  • Pain Control
Intervention  ICMJE Procedure: 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
Study Arms  ICMJE
  • Active Comparator: Open-mouth
    Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open
    Intervention: Procedure: Local anesthesia
  • Experimental: Closed-mouth
    Patients receiving MBIA using a closed-mouth technique
    Intervention: Procedure: Local anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2019)		 120
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)		 100
Actual Study Completion Date  ICMJE June 23, 2019
Actual Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03921190
Other Study ID Numbers  ICMJE 1012018/3686
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmad El-Ma'aita, University of Jordan
Study Sponsor  ICMJE University of Jordan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmad El-Ma'aita, PhD University of Jordan
PRS Account University of Jordan
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP