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

Not Applicable

Completed

• Conditions: Pain Control; Anesthesia, Local
• Interventions: Procedure: Local anesthesia

• Registration Number: NCT03921190
• Lead Sponsor: University of Jordan

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 Timeline

• Study First Submitted: 2019-03-30
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Study Start: 2019-04-29
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-23
• Results First Submitted: 2020-12-06
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-27
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closed-mouth	Local anesthesia	Patients receiving MBIA using a closed-mouth technique
Open-mouth	Local anesthesia	Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open

Primary Outcome Measures

Name	Time	Method
Patient Pain Perception	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.

Secondary Outcome Measures

Name	Time	Method
Dentist Perception of Visibility During Anesthesia Injection	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	3-60 days	Number of dentists preferring each technique

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Select One, Jordan