Irreversible PulpitisNCT06245161
Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients
A study testing Quicksleeper5 and conventional anesthesia in people with Irreversible Pulpitis and Tooth Extraction, run by Alexandria University at 1 site in Egypt.
Trial summary
To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis, Tooth Extraction
- What is being tested?
- Quicksleeper5 and conventional anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to May 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
- Cooperative children during preoperative assessments.
- Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination.
- Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction.
Who cannot join
- Any physical or mental disability, or psychological problems.
- Immunocompromised patients.
- Hypersensitivity to local anesthetic drugs used
- History of previous dental local anesthesia.
- Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative
Trial locations and contacts
1 site in 1 country.
Nadia Wahba, Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University- Faculty of Dentistry
Alexandria, Alexandroa
sara Quritum, +201020019396, sara.quritum@alexu.edu.eg
Nadia Wahba, Prof., drnadiawahba@gmail.com
About this study
Official title: Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)
To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia.
Read the detailed description
The study will be an eight-armed randomized controlled trial, parallel design. A total of 120 pediatric dental patients aged from 5 to 9 years with good health, will be selected from the Pediatric Dentistry and Dental Public Health Department clinic, Faculty of Dentistry, Alexandria University, Egypt. They will be recruited among those who need local anesthesia to perform either quadrant restorative treatment or extraction of their primary molars. Participants will be allocated into 2 groups according to the local anesthetic technique to be used. Children in the test group will receive intraosseous anesthesia using QuickSleeper5, while inferior alveolar nerve block or infiltration anesthesia will be used for those who are in the control group. All the procedures will be videotaped. Pain response upon needle prick and dental treatment will be assessed subjectively using the visual analogue scale, and objectively using Face, Leg, Activity, cry, Consolability scale. Physiological parameters will also be recorded to determine pain reaction. Efficacy, latency period and duration of anesthesia will be recorded for both injection techniques. Child behaviour toward dental treatment in both injection techniques will be evaluated using Frankl rating scale. Dental anxiety of pediatric patients will be evaluated from the videotapes using VENHAM Clinical Anxiety Scale. Postoperative assessment for the occurrence of any adverse events is planned.
- Conditions
- Irreversible Pulpitis, Tooth Extraction
- Being tested
- Quicksleeper5, conventional anesthesia
- Keywords
- Intraosseous anesthesia, Computer-controlled injection, pain management, dental anesthesia, pediatric dentistry
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quicksleeper5Device
intraosseous anesthesia for dental treatment
conventional anesthesiaDevice
inferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars
| Study group | Role | What they receive |
|---|---|---|
| • Group IA | Experimental | 15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. Receives: Device: Quicksleeper5 |
| • Group IB | Active comparator | 15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to infiltration anesthesia Receives: Device: conventional anesthesia |
| • Group IC | Experimental | 15 Mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. Receives: Device: Quicksleeper5 |
| • Group ID | Active comparator | 15 mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to inferior alveolar nerve block (IANB) anesthesia Receives: Device: conventional anesthesia |
| • Group IIA | Experimental | 15 maxillary primary molars indicated for extraction allocated to Intra-osseous Anesthesia by QuickSleeper5 Receives: Device: Quicksleeper5 |
| • Group IIB | Active comparator | 15 maxillary primary molars indicated for extraction allocated to Infiltration anesthesia Receives: Device: conventional anesthesia |
| • Group IIC | Experimental | 15 Mandibular primary molars indicated for extraction, allocated to Intra-osseous Anesthesia by QuickSleeper5 Receives: Device: Quicksleeper5 |
| • Group IID | Active comparator | 15 Mandibular primary molars indicated for extraction, allocated to inferior alveolar nerve block (IANB) anesthesia. Receives: Device: conventional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain Reaction objectively
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale
Measured: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
Assessment of Pain Reaction subjectively
it will done by the child using Face version of Visual Analogue Scale.
Measured: 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
Child dental anxiety
It will be assessed using VENHAM Clinical Anxiety Scale
Measured: 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
Secondary outcomes (2)
Local anesthesia effect
efficacy of anesthesia (using efficacy scale by Sixou et al )
Measured: 30 minutes postoperatively
Assessment of occurrence of adverse events
the occurrence of self-inflicted injury, pain at injection site or trismus, or any adverse events.
Measured: follow up 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 120 children eligible for the study will be divided into: Group I (restorative group): includes 60 quadrants, each have at least one primary molar indicated for restorative treatment or vital pulp therapy. It will be subdivided into 4 subgroups, each consists of 15 quadrant (upper and lower) allocated to Intra-osseous Anesthesia by QuickSleeper5 for the test groups or to infiltration or IANB in the control group Group II (extraction group): includes 60 primary molars indicated for extraction. It will be subdivided into 4 subgroups; according either maxillary or mandibular primary molar is indicated for extraction, using Intra-osseous Anesthesia by QuickSleeper5 for the test groups ,or infiltration or IANB in the control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sara quritum, Principal investigator, Alexandria Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245161
- Sponsor's protocol ID
- 0588-01/2023
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06245161
- Acronym / sponsor ID
- 0588-01/2023
- Conditions
- Irreversible Pulpitis, Tooth Extraction
- Keywords
- Intraosseous anesthesia, Computer-controlled injection, pain management, dental anesthesia, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 7 Feb 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.
To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia.
Detailed description
The study will be an eight-armed randomized controlled trial, parallel design. A total of 120 pediatric dental patients aged from 5 to 9 years with good health, will be selected from the Pediatric Dentistry and Dental Public Health Department clinic, Faculty of Dentistry, Alexandria University, Egypt. They will be recruited among those who need local anesthesia to perform either quadrant restorative treatment or extraction of their primary molars. Participants will be allocated into 2 groups according to the local anesthetic technique to be used. Children in the test group will receive intraosseous anesthesia using QuickSleeper5, while inferior alveolar nerve block or infiltration anesthesia will be used for those who are in the control group. All the procedures will be videotaped. Pain response upon needle prick and dental treatment will be assessed subjectively using the visual analogue scale, and objectively using Face, Leg, Activity, cry, Consolability scale. Physiological parameters will also be recorded to determine pain reaction. Efficacy, latency period and duration of anesthesia will be recorded for both injection techniques. Child behaviour toward dental treatment in both injection techniques will be evaluated using Frankl rating scale. Dental anxiety of pediatric patients will be evaluated from the videotapes using VENHAM Clinical Anxiety Scale. Postoperative assessment for the occurrence of any adverse events is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- 120 children eligible for the study will be divided into: Group I (restorative group): includes 60 quadrants, each have at least one primary molar indicated for restorative treatment or vital pulp therapy. It will be subdivided into 4 subgroups, each consists of 15 quadrant (upper and lower) allocated to Intra-osseous Anesthesia by QuickSleeper5 for the test groups or to infiltration or IANB in the control group Group II (extraction group): includes 60 primary molars indicated for extraction. It will be subdivided into 4 subgroups; according either maxillary or mandibular primary molar is indicated for extraction, using Intra-osseous Anesthesia by QuickSleeper5 for the test groups ,or infiltration or IANB in the control group
| Arm | Type | Receives |
|---|---|---|
| • Group IA | Experimental | Device: Quicksleeper515 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. |
| • Group IB | Active comparator | Device: conventional anesthesia15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to infiltration anesthesia |
| • Group IC | Experimental | Device: Quicksleeper515 Mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5. |
| • Group ID | Active comparator | Device: conventional anesthesia15 mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to inferior alveolar nerve block (IANB) anesthesia |
| • Group IIA | Experimental | Device: Quicksleeper515 maxillary primary molars indicated for extraction allocated to Intra-osseous Anesthesia by QuickSleeper5 |
| • Group IIB | Active comparator | Device: conventional anesthesia15 maxillary primary molars indicated for extraction allocated to Infiltration anesthesia |
| • Group IIC | Experimental | Device: Quicksleeper515 Mandibular primary molars indicated for extraction, allocated to Intra-osseous Anesthesia by QuickSleeper5 |
| • Group IID | Active comparator | Device: conventional anesthesia15 Mandibular primary molars indicated for extraction, allocated to inferior alveolar nerve block (IANB) anesthesia. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cooperative children during preoperative assessments.
- Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination.
- Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction.
Key exclusion criteria (5 listed)
- Any physical or mental disability, or psychological problems.
- Immunocompromised patients.
- Hypersensitivity to local anesthetic drugs used
- History of previous dental local anesthesia.
- Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative
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 |
|---|---|---|
| Quicksleeper5intraosseous anesthesia for dental treatment | Device | • Group IA, • Group IC, • Group IIA, • Group IIC |
| conventional anesthesiainferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars | Device | • Group IB, • Group ID, • Group IIB, • Group IID |
Primary outcome
Assessment of Pain Reaction objectively
Time frame: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction
Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale
Assessment of Pain Reaction subjectively
Time frame: 1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)
it will done by the child using Face version of Visual Analogue Scale.
Child dental anxiety
Time frame: 1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)
It will be assessed using VENHAM Clinical Anxiety Scale
2 secondary outcomes
Local anesthesia effect
Time frame: 30 minutes postoperatively
Assessment of occurrence of adverse events
Time frame: follow up 24 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Nadia Wahba, Prof contact
sara quritum principal investigator
Alexandria Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quicksleeper5 and conventional anesthesia in people with Irreversible Pulpitis and Tooth Extraction, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Feb 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara Quritum, PhD (+201020019396, sara.quritum@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain Reaction objectively (time frame: 1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction). The study lists 3 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 7 Feb 2024.