Trial Outcomes & Findings for Should Maxillary Buccal Infiltration Anesthesia be Given in a Closed Mouth Technique? (NCT NCT03921190)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

5 minutes after receiving the injection

Results posted on

2021-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Open-mouth Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open 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	Closed-mouth Patients receiving MBIA using a closed-mouth technique 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
Overall Study STARTED	56	64
Overall Study COMPLETED	56	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-mouth n=56 Participants Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open 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	Closed-mouth n=64 Participants Patients receiving MBIA using a closed-mouth technique 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	Total n=120 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 14.7 • n=56 Participants	39.6 years STANDARD_DEVIATION 14.9 • n=64 Participants	39.3 years STANDARD_DEVIATION 14.85 • n=120 Participants
Sex: Female, Male Female	31 Participants n=56 Participants	38 Participants n=64 Participants	69 Participants n=120 Participants
Sex: Female, Male Male	25 Participants n=56 Participants	26 Participants n=64 Participants	51 Participants n=120 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 5 minutes after receiving the injection

Population: Study participants

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.

Outcome measures

Outcome measures
Measure	Open-mouth n=56 Participants Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Closed-mouth n=64 Participants Patients receiving MBIA using a closed-mouth technique
Patient Pain Perception	32.6 millimeters on a visual analogue scale Standard Deviation 15.8	25 millimeters on a visual analogue scale Standard Deviation 14

SECONDARY outcome

Timeframe: 30-60 days

Population: Patients receiving maxillary buccal infiltration anesthesia

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.

Outcome measures

Outcome measures
Measure	Open-mouth n=233 Participants Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Closed-mouth n=236 Participants Patients receiving MBIA using a closed-mouth technique
Dentist Perception of Visibility During Anesthesia Injection Visibility during injection	68.1 millimeters on a visual analogue scale Standard Deviation 17.1	82.6 millimeters on a visual analogue scale Standard Deviation 14.3
Dentist Perception of Visibility During Anesthesia Injection Ease of cheek retraction	64.9 millimeters on a visual analogue scale Standard Deviation 20.1	83.2 millimeters on a visual analogue scale Standard Deviation 12.7

SECONDARY outcome

Timeframe: 3-60 days

Population: Practicing dentists performing local anesthesia

Number of dentists preferring each technique

Outcome measures

Outcome measures
Measure	Open-mouth n=48 Participants Patients receiving maxillary buccal infiltration anesthesia (MBIA) with their mouth wide open	Closed-mouth n=48 Participants Patients receiving MBIA using a closed-mouth technique
Dentist Preference of Performing One of the Two Techniques of Maxillary Buccal Infiltration; Open-mouth or Closed-mouth	3 Participants	38 Participants

Adverse Events

Open-mouth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Closed-mouth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ahmad El-Ma'aita

University of Jordan

Phone: +9625355000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place