Computer-controlled Intraligamentary AnaesthesiaRCTNCT06669039
Comparison of the Computer Controlled and Conventional Local Anesthesia Techniques in Primary Molar Extraction in Children Aged 5 to 9 Years Old
A study testing Inferior Alveolar Nerve Block in people with Computer-controlled Intraligamentary Anaesthesia and Inferior Alveolar Nerve Block, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer-controlled Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Pain Perception
- What is being tested?
- Inferior Alveolar Nerve Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Nov 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children (ASA I).
- Ranging in age from 5-9.
- Cooperative (Frankle ++).
- With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.
Who cannot join
- Mobile teeth (Grade III).
- Ankylosed teeth.
- Teeth with root resorption (more than 1\3).
- Patients with facial cellulitis and when there is a need for supplemental anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail
The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.
The main questions it aims to answer are:
Read more
Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.
Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.
Participants will:
Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.
Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.
- Conditions
- Computer-controlled Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Pain Perception, Anesthesia Effectiveness
- Being tested
- Computer-controlled Local Anesthetic delivery system, Inferior Alveolar Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-controlled Local Anesthetic delivery systemDevice
Local anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system.
Inferior Alveolar Nerve BlockProcedure or surgery
Local anesthesia will be delivered using the conventional syringe
| Study group | Role | What they receive |
|---|---|---|
| Conventional Inferior Alveolar nerve block | Active comparator | Not described Receives: Procedure: Inferior Alveolar Nerve Block |
| Computer-controlled Intraligamentary local anaesthesia | Experimental | Not described Receives: Device: Computer-controlled Local Anesthetic delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
Measured: Immediately after receiving anesthesia
Pain
Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain"
Measured: Immediately after receiving anesthesia
Stress level
Child stress level after receiving either of anesthesia will be determined using salivary cortisol which will be collected by cortisol ELISA kit
Measured: Before and after local anesthesia delivery
Effectiveness
Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain"
Measured: Through dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start17 Nov 2023
- Primary completion5 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer-controlled Intraligamentary AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Saleh AlGhamdi, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669039
- Sponsor's protocol ID
- 109-05-23
- Acronym
- RCT
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Pain perception scores, operator pain assessment scores and the anesthesia effectiveness scores.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT06669039
- Acronym / sponsor ID
- RCT / 109-05-23
- Conditions
- Computer-controlled Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Pain Perception, Anesthesia Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.
The main questions it aims to answer are:
Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.
Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.
Participants will:
Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.
Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Inferior Alveolar nerve block | Active comparator | Procedure: Inferior Alveolar Nerve Block |
| Computer-controlled Intraligamentary local anaesthesia | Experimental | Device: Computer-controlled Local Anesthetic delivery system |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children (ASA I).
- Ranging in age from 5-9.
- Cooperative (Frankle ++).
- With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.
Key exclusion criteria (4 listed)
- Mobile teeth (Grade III).
- Ankylosed teeth.
- Teeth with root resorption (more than 1\3).
- Patients with facial cellulitis and when there is a need for supplemental anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-controlled Local Anesthetic delivery systemLocal anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system. | Device | Computer-controlled Intraligamentary local anaesthesia |
| Inferior Alveolar Nerve BlockLocal anesthesia will be delivered using the conventional syringe | Procedure or surgery | Conventional Inferior Alveolar nerve block |
Primary outcome
Pain
Time frame: Immediately after receiving anesthesia
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
Pain
Time frame: Immediately after receiving anesthesia
Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain"
Stress level
Time frame: Before and after local anesthesia delivery
Child stress level after receiving either of anesthesia will be determined using salivary cortisol which will be collected by cortisol ELISA kit
Effectiveness
Time frame: Through dental procedure
Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Yes. Pain perception scores, operator pain assessment scores and the anesthesia effectiveness scores.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block in people with Computer-controlled Intraligamentary Anaesthesia and Inferior Alveolar Nerve Block, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Immediately after receiving anesthesia). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.