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

NCT ID: NCT03921190

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2019-06-23

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.

Conditions

Anesthesia, Local; Pain Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Open-mouth

Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open

Group Type: ACTIVE_COMPARATOR

Local anesthesia

Intervention Type: PROCEDURE

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

Closed-mouth

Patients receiving MBIA using a closed-mouth technique

Group Type: EXPERIMENTAL

Local anesthesia

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: lead

Responsible Party

Ahmad El-Ma'aita

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad El-Ma'aita, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jordan

Locations

Jordan University Hospital

Amman, Select One, Jordan

Countries

Jordan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1012018/3686

Identifier Type: -

Identifier Source: org_study_id