Pain Perception of the New DevicePhase 1STA machineNCT02025140
Computer Controlled Local Anesthesia in Children
A Phase 1 study testing conventional anesthesia syringe in people with Pain Perception of the New Device and The Pain Related Behavior, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness of pain control in children can be influenced by child characteristics . Objectives: The Purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Perception of the New Device, The Pain Related Behavior, The Effectiveness of Anesthesia
- What is being tested?
- conventional anesthesia syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 1
- 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
The inclusion criteria:
- Age of the children was ranged from 5-9 years.
- Children were healthy physically and mentally; all children had no contraindications to local anesthesia.
- Children were assessed as being cooperative, had behavioral ratings "positive" or "definitely positive" according to the Frankl (Frankl et al 1962) behavior classification scale (appendix1).
- Children were diagnosed with carious mandibular second primary molars that required treatment with pulpotomies.
The exclusion criteria:
- Disapproved consent.
- Medically compromised children.
- Uncooperative children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
- Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness of pain control in children can be influenced by child characteristics .
Objectives: The Purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second primary molars.
Materials and Methodology: The study sample includes 90 healthy children who are selected randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH) with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the mandibular second molars. The sample will be divided randomly to one of these 3 groups: group A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30 patients will be assigned in group C and will be anesthetized by periodontal ligament injection anesthesia using the CCLAD. The pain perception levels after the injection is assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24 hours parents will be contacted by the telephone to ask about the presence of postoperative pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.
Read the detailed description
Ethical Consideration:
The Ethical Committee of King Abdulaziz University KAAUEC approved the study .
Subjects' selection:
The Sample includes children who are randomly selected by the R4 electronic file system in the pediatric dentistry specialty clinics at King Abdulaziz University Hospital (KAUH). A total of 2100 pediatric screening had been registered between April 2013 and November 2013 .These files will be checked for the eligible age in the study which is 5-9 years. Then, the inclusion and exclusion criteria will be checked, and the patients will be selected by systemic random sample.
Study design:
This is a randomized single blind clinical trial study.
- Conditions
- Pain Perception of the New Device, The Pain Related Behavior, The Effectiveness of Anesthesia
- Being tested
- Computer controlled anesthesia, conventional anesthesia syringe
- Keywords
- Computer controlled anesthesia (CCLAD), pain perception, Effectiveness, primary molars, Behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer controlled anesthesiaDevice
Also called (The Wand), STA machine
The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
conventional anesthesia syringeDevice
Also called Inferior alveolar nerve block injection
Active control
| Study group | Role | What they receive |
|---|---|---|
| : This group consisted of 30 patients. | Active comparator | The traditional IANB injection was given according to the standard technique (Evers and Haegerstam 1981). From everyday practice, it is known that the present operator takes approximately 60 to 90 seconds to give a mandibular block Receives: Device: conventional anesthesia syringe |
| 30 IANB with Computer controlled | Experimental | The IANB injection was given by a computer- regulated device performed with the STA system. The IANB injection was given according to the manufacturer's instruction (the model was used is the STA Single Tooth Anesthesia System produced by Milestone Scientific, Livingston, NJ). Receives: Device: Computer controlled anesthesia |
| consisted of 30 periodontal anesthesia | Experimental | The interligamental injection was given by computer- regulated device performed with the STA system. Receives: Device: Computer controlled anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain perception of the children to the device
No follow up is required, the out come is measured immediately after completion of the injection
Measured: 1-2 minutes
Secondary outcomes (1)
The effectiveness of the anesthesia
The sound eye motor scale is used during different stages of procedure.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Perception of the New DeviceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Khlood Baghlaf, King Abdulaziz University
- Investigators
- Prof Najlaa M Alamoudi, PHD, Principal investigator, King Abdulazize University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025140
- Sponsor's protocol ID
- 3
- Acronym
- STA machine
- Status last verified
- Sep 2015
- First submitted
- 25 Nov 2013
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
- ClinicalTrials.gov ID
- NCT02025140
- Acronym / sponsor ID
- STA machine / 3
- Conditions
- Pain Perception of the New Device, The Pain Related Behavior, The Effectiveness of Anesthesia
- Keywords
- Computer controlled anesthesia (CCLAD), pain perception, Effectiveness, primary molars, Behavior
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- 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.
- Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness of pain control in children can be influenced by child characteristics .
Objectives: The Purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second primary molars.
Materials and Methodology: The study sample includes 90 healthy children who are selected randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH) with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the mandibular second molars. The sample will be divided randomly to one of these 3 groups: group A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30 patients will be assigned in group C and will be anesthetized by periodontal ligament injection anesthesia using the CCLAD. The pain perception levels after the injection is assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24 hours parents will be contacted by the telephone to ask about the presence of postoperative pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.
Detailed description
Ethical Consideration:
The Ethical Committee of King Abdulaziz University KAAUEC approved the study .
Subjects' selection:
The Sample includes children who are randomly selected by the R4 electronic file system in the pediatric dentistry specialty clinics at King Abdulaziz University Hospital (KAUH). A total of 2100 pediatric screening had been registered between April 2013 and November 2013 .These files will be checked for the eligible age in the study which is 5-9 years. Then, the inclusion and exclusion criteria will be checked, and the patients will be selected by systemic random sample.
Study design:
This is a randomized single blind clinical trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| : This group consisted of 30 patients. | Active comparator | Device: conventional anesthesia syringeThe traditional IANB injection was given according to the standard technique (Evers and Haegerstam 1981). From everyday practice, it is known that the present operator takes approximately 60 to 90 seconds to give a mandibular block |
| 30 IANB with Computer controlled | Experimental | Device: Computer controlled anesthesiaThe IANB injection was given by a computer- regulated device performed with the STA system. The IANB injection was given according to the manufacturer's instruction (the model was used is the STA Single Tooth Anesthesia System produced by Milestone Scientific, Livingston, NJ). |
| consisted of 30 periodontal anesthesia | Experimental | Device: Computer controlled anesthesiaThe interligamental injection was given by computer- regulated device performed with the STA system. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 anesthesiaAlso: (The Wand), STA machineThe IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD | Device | 30 IANB with Computer controlled, consisted of 30 periodontal anesthesia |
| conventional anesthesia syringeAlso: Inferior alveolar nerve block injectionActive control | Device | : This group consisted of 30 patients. |
Primary outcome
The pain perception of the children to the device
Time frame: 1-2 minutes
No follow up is required, the out come is measured immediately after completion of the injection
1 secondary outcome
The effectiveness of the anesthesia
Time frame: During the procedure
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 2 Sep 2015.
- Related InfoLink provided by the sponsor.
Related trials for Pain Perception of the New Device
Not yet recruiting
Effect of Starpen Injection Device Versus Conventional Syringe During Anesthesia and Extraction of Primary Molars
Pain Perception of the New Device
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.
Prof Najlaa M Alamoudi, PHD principal investigator
King Abdulazize University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing conventional anesthesia syringe in people with Pain Perception of the New Device and The Pain Related Behavior, 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?
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 2 Sep 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The pain perception of the children to the device (time frame: 1-2 minutes). 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 2 Sep 2015.