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Completed

NCT Number: NCT03921190

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, Select One, 11831, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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