Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars

• ClinicalTrials.gov Identifier: NCT04739735
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Results First Posted: January 10, 2022
• Last Update Posted: January 10, 2022
• Sponsor: Alexandria University
• Information provided by (Responsible Party): Rodaina Helmy, Alexandria University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Local Anaesthetic Drug Adverse Reaction
• Intervention: Procedure: Dental Local Anaesthesia
• Enrollment: 50

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Computer Controlled -Intraligamentary Anesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description	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	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 The needle is withdrawn, then 0.5 ml as a long buccal infiltration distal to the second primary molar is administered.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
Period Title: Overall Study
Started	25	25
Completed	25	25
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block	Total
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		25	25	50
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	25 participants	50 participants
		6.20 (0.71)	6.00 (0.82)	6.10 (0.76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	25 participants	50 participants
	Female	14 56.0%	15 60.0%	29 58.0%
	Male	11 44.0%	10 40.0%	21 42.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Egypt	Number Analyzed	25 participants	25 participants	50 participants
		25	25	50
tooth location; Measure Type: Number; Unit of measure: Teeth
First primary molar	Number Analyzed	25 participants	25 participants	50 participants
		15	15	30
Second primary molar	Number Analyzed	25 participants	25 participants	50 participants
		10	10	20

Outcome Measures

1. Primary Outcome

Title	Baseline Heart Rate
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Mean (Standard Deviation); Unit of Measure: beats per minute
	99.92 (12.67)	98.80 (15.30)

2. Primary Outcome

Title	Heart Rate Measurement in Local Anaesthetic Administration
Description	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.
Time Frame	starting from needle puncture till full local anaesthetic solution delivery. Time frame is approximately minute 2 - 4.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Mean (Standard Deviation); Unit of Measure: beats per minute
	104.64 (12.04)	113.48 (16.66)

3. Primary Outcome

Title	Heart Rate Measurement in Extraction
Description	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.
Time Frame	patient was allowed to rest for approximately 5 minutes after the injection then extraction was started. Time frame is approximately minute 9 -10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Mean (Standard Deviation); Unit of Measure: beats per minute
	107.68 (14.33)	114.44 (19.57)

4. Primary Outcome

Title	SEM Scale in Local Anaesthetic Administration
Description	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.
Time Frame	approximately minute 2 - 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Median (Inter-Quartile Range); Unit of Measure: score on a scale
	3; (3 to 4)	9; (5 to 9)

5. Primary Outcome

Title	SEM Scale in Extraction
Description	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.
Time Frame	approximately minute 9 - 10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Median (Inter-Quartile Range); Unit of Measure: score
	4; (3 to 8)	7; (5 to 11)

6. Primary Outcome

Title	Face Pain Rating Scale in Local Anaesthetic Administration
Description	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.
Time Frame	approximately minute 2 - 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Measure Type: Number; Unit of Measure: participants
happy	22	14
indifferent	2	0
sad	1	11

7. Primary Outcome

Title	Face Pain Rating Scale in Extraction
Description	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.
Time Frame	approximately minute 9 - 10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Measure Type: Number; Unit of Measure: participants
happy	21	13
indifferent	2	0
sad	2	12

8. Secondary Outcome

Title	Assessment of Occurrence of Adverse Events
Description	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.
Time Frame	after 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)	Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description:	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	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 Number of Participants Analyzed	25	25
Measure Type: Number; Unit of Measure: participants
Lip biting after 24 hours	0	8
Post operative pain after 24 hours	5	10

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	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.
Arm/Group Title	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)		Conventional Injection of Inferior Alveolar Nerve Block
Arm/Group Description	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		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
All-Cause Mortality
	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)		Conventional Injection of Inferior Alveolar Nerve Block
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/25 (0.00%)		0/25 (0.00%)
Serious Adverse Events
	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)		Conventional Injection of Inferior Alveolar Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Computer Controlled -Intraligamentary Aaanesthesia (CC-ILA)		Conventional Injection of Inferior Alveolar Nerve Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		8/25 (32.00%)
Injury, poisoning and procedural complications
lip/cheek biting * [1]	0/25 (0.00%)	0	8/25 (32.00%)	8
* Indicates events were collected by non-systematic assessment; [1] due to the numbness of the soft tissues caused by local anesthetic drug injection, the child could heavily bite/injure their cheeks or lower lip unconsciously, which becomes very painful after the anesthesia effect is over.

Limitations and Caveats

the children could not be blinded to the method of local anaesthesia used.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Rodaina Helmy
• Organization: Faculty of dentistry, Alexandria University, Egypt
• Phone: 00201100001193
• EMail: rodaina.helmy@alexu.edu.eg

Publications:

Maunuksela EL, Olkkola KT, Korpela R. Measurement of pain in children with self-reporting and behavioral assessment. Clin Pharmacol Ther. 1987 Aug;42(2):137-41. doi: 10.1038/clpt.1987.123.

American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on pediatric oral surgery. Pediatr Dent. 2005-2006;27(7 Suppl):158-64. No abstract available.

Alamoudi NM, Baghlaf KK, Elashiry EA, Farsi NM, El Derwi DA, Bayoumi AM. The effectiveness of computerized anesthesia in primary mandibular molar pulpotomy: A randomized controlled trial. Quintessence Int. 2016 Mar;47(3):217-24. doi: 10.3290/j.qi.a34977.

Ran D, Peretz B. Assessing the pain reaction of children receiving periodontal ligament anesthesia using a computerized device (Wand). J Clin Pediatr Dent. 2003 Spring;27(3):247-50.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Helmy RH, Zeitoun SI, El-Habashy LM. Computer-controlled Intraligamentary local anaesthesia in extraction of mandibular primary molars: randomised controlled clinical trial. BMC Oral Health. 2022 May 20;22(1):194. doi: 10.1186/s12903-022-02194-2.

• Responsible Party: Rodaina Helmy, Alexandria University
• ClinicalTrials.gov Identifier: NCT04739735
• Other Study ID Numbers: 00010556 - 0008839
• First Submitted: January 26, 2021
• First Posted: February 5, 2021
• Results First Submitted: October 14, 2021
• Results First Posted: January 10, 2022
• Last Update Posted: January 10, 2022