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

NCT03921190 | Completed Results DMC

• 1 other identifier: 1012018/3686
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Local; Pain Control

Keywords

Buccal infiltration anesthesia; Discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dentist Perception of Visibility During Anesthesia Injection

  30-60 days

• Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth

  3-60 days

Study Arms (2)

Open-mouth

ACTIVE COMPARATOR

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

Procedure: Local anesthesia

Closed-mouth

EXPERIMENTAL

Patients receiving MBIA using a closed-mouth technique

Procedure: Local anesthesia

Interventions

Local anesthesia 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; Open-mouth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, Select One, 11831, Jordan

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Ahmad El-Ma'aita
• Organization: University of Jordan

a.maaita@ju.edu.jo

+9625355000

Study Officials

• Ahmad El-Ma'aita, PhD

  University of Jordan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth

Study Record Dates

• First Submitted: March 30, 2019
• First Posted: April 19, 2019
• Study Start: April 29, 2019
• Primary Completion: June 20, 2019
• Study Completion: June 23, 2019
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Locations

JO (1)