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

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ClinicalTrials.gov Identifier: NCT03921190
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmad El-Ma'aita, 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

Condition or disease Intervention/treatment Phase
Anesthesia, Local Pain Control Procedure: Local anesthesia Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Providing dental local anesthesia (maxillary buccal infiltration) using two techniques; open-mouth and closed-mouth
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique? - a Clinical Study
Actual Study Start Date : April 29, 2019
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 23, 2019

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




Primary Outcome Measures :
  1. Patient perception [ Time Frame: 30-60 days ]
    Patient perception of pain/ discomfort during injection will be recorded on a standard 100mm visual analogue scale where 100 is the worst imaginable pain and 0 is no pain at all. The patient's reported value will be registered as a numerical value and the means for the two groups will be compared to detect any statistical difference


Secondary Outcome Measures :
  1. Dentist perception [ Time Frame: 30-60 days ]
    Participating dentists will be asked to rate the visibility of injection site and ease of cheek retraction on a standard 100mm visual analogue scale where 100 indicates the best possible visibility/ ease of cheek retraction and 0 means no visibility at all/ impossible cheek retraction. Finally the dentists will be asked to register their own preference of performing either of the two techniques (if any)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921190


Locations
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Jordan
Jordan University Hospital
Amman, Select One, Jordan, 11831
Sponsors and Collaborators
University of Jordan
Investigators
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Principal Investigator: Ahmad El-Ma'aita, PhD University of Jordan

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Responsible Party: Ahmad El-Ma'aita, Principal investigator, University of Jordan
ClinicalTrials.gov Identifier: NCT03921190     History of Changes
Other Study ID Numbers: 1012018/3686
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmad El-Ma'aita, University of Jordan:
Buccal infiltration anesthesia
Discomfort
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs