Trial Outcomes & Findings for Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars (NCT NCT04739735)

NCT ID: NCT04739735

Last Updated: 2022-01-10

Results Overview

Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2

Results posted on

2022-01-10

Participant Flow

Participant milestones

Participant milestones
Measure
Computer Controlled -Intraligamentary Anesthesia (CC-ILA)
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Overall Study
STARTED
25
25
Overall Study
COMPLETED
25
25
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
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Total
n=50 Participants
Total of all reporting groups
Age, Customized
6.20 years
STANDARD_DEVIATION 0.71 • n=25 Participants
6.00 years
STANDARD_DEVIATION 0.82 • n=25 Participants
6.10 years
STANDARD_DEVIATION 0.76 • n=50 Participants
Sex: Female, Male
Female
14 Participants
n=25 Participants
15 Participants
n=25 Participants
29 Participants
n=50 Participants
Sex: Female, Male
Male
11 Participants
n=25 Participants
10 Participants
n=25 Participants
21 Participants
n=50 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Egypt
25 participants
n=25 Participants
25 participants
n=25 Participants
50 participants
n=50 Participants
tooth location
First primary molar
15 teeth
n=25 Participants
15 teeth
n=25 Participants
30 teeth
n=50 Participants
tooth location
Second primary molar
10 teeth
n=25 Participants
10 teeth
n=25 Participants
20 teeth
n=50 Participants

PRIMARY outcome

Timeframe: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2

Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Baseline Heart Rate
99.92 beats per minute
Standard Deviation 12.67
98.80 beats per minute
Standard Deviation 15.30

PRIMARY outcome

Timeframe: starting from needle puncture till full local anaesthetic solution delivery. Time frame is approximately minute 2 - 4.

Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Heart Rate Measurement in Local Anaesthetic Administration
104.64 beats per minute
Standard Deviation 12.04
113.48 beats per minute
Standard Deviation 16.66

PRIMARY outcome

Timeframe: patient was allowed to rest for approximately 5 minutes after the injection then extraction was started. Time frame is approximately minute 9 -10

Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Heart Rate Measurement in Extraction
107.68 beats per minute
Standard Deviation 14.33
114.44 beats per minute
Standard Deviation 19.57

PRIMARY outcome

Timeframe: approximately minute 2 - 4

Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
SEM Scale in Local Anaesthetic Administration
3 score on a scale
Interval 3.0 to 4.0
9 score on a scale
Interval 5.0 to 9.0

PRIMARY outcome

Timeframe: approximately minute 9 - 10

Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
SEM Scale in Extraction
4 score
Interval 3.0 to 8.0
7 score
Interval 5.0 to 11.0

PRIMARY outcome

Timeframe: approximately minute 2 - 4

A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Face Pain Rating Scale in Local Anaesthetic Administration
happy
22 participants
14 participants
Face Pain Rating Scale in Local Anaesthetic Administration
indifferent
2 participants
0 participants
Face Pain Rating Scale in Local Anaesthetic Administration
sad
1 participants
11 participants

PRIMARY outcome

Timeframe: approximately minute 9 - 10

A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Face Pain Rating Scale in Extraction
happy
21 participants
13 participants
Face Pain Rating Scale in Extraction
indifferent
2 participants
0 participants
Face Pain Rating Scale in Extraction
sad
2 participants
12 participants

SECONDARY outcome

Timeframe: after 24 hours

Parents will be recalled after 24 hours following extraction during follow-up phone calls. Recovery parameter questions will be asked to ascertain the occurrence of lip and cheek biting, post-operative pain, or any adverse events.

Outcome measures

Outcome measures
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 Participants
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 Participants
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Assessment of Occurrence of Adverse Events
Lip biting after 24 hours
0 participants
8 participants
Assessment of Occurrence of Adverse Events
Post operative pain after 24 hours
5 participants
10 participants

Adverse Events

Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Conventional Injection of Inferior Alveolar Nerve Block

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)
n=25 participants at risk
CC-ILA will be administered using the Wand-STA system according to the manufacturer instructions, It works with standardised 1.8 mL local anaesthetic carpules. The distalingual and mesiolingual line angles are the most effective for multi-rooted mandibular teeth. Articaine hydrochloride 4% with 1:100,000 epinephrine will be injected for each root as shown on a special indicator.The dentist will wait 5 seconds before needle withdrawal. Same steps will be repeated at the mesiolingual line angle. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Conventional Injection of Inferior Alveolar Nerve Block
n=25 participants at risk
* In the control group, a standard technique for the Inferior Alveolar Nerve Block (IANB) will be used supplemented with long buccal infiltration for the buccal gingiva. * A 27-gauge disposable dental needle will be used to inject Articaine hydrochloride 4% with 1:100,000 epinephrine. The needle will be directed between the two primary molars on the opposite side of the arch, entering the tissues at the level of the occlusal plane or slightly lower until bony resistance is met. Approximately 1.0 mL of LA will be delivered near the inferior alveolar nerve. Two-thirds the needle length should be inserted. The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered. Dental Local Anaesthesia: lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
Injury, poisoning and procedural complications
lip/cheek biting
0.00%
0/25 • 4 months
The present study aims to assess the children's behavioural experience while performing a routine dental procedure. There is no risk in any of the clinical interventions. Furthermore, the participants randomly selected should meet the eligibility criteria which includes a completely normal healthy patient with score ASA I in the American Society of Anesthesiologists scale.
32.0%
8/25 • Number of events 8 • 4 months
The present study aims to assess the children's behavioural experience while performing a routine dental procedure. There is no risk in any of the clinical interventions. Furthermore, the participants randomly selected should meet the eligibility criteria which includes a completely normal healthy patient with score ASA I in the American Society of Anesthesiologists scale.

Additional Information

Dr. Rodaina Helmy

Faculty of dentistry, Alexandria University, Egypt

Phone: 00201100001193

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place