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

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

To study the patients' and dentists' perception of receiving/ administering maxillary buccal infiltration anesthesia using an open or closed mouth techniques

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Pain Control
• Intervention / Treatment: Procedure: Local anesthesia

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Select One
    • Amman, Select One, Jordan, 11831
      • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open-mouth; Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	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
Experimental: Closed-mouth; Patients receiving MBIA using a closed-mouth technique	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Jordan
• Investigators: Principal Investigator: Ahmad El-Ma'aita, PhD, University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 23, 2019

Study Registration Dates

• First Submitted: March 30, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Discomfort; Buccal infiltration anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1012018/3686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No