No Condition, Assessment of Healthy VolunteersNCT07108439
Usefulness of Intraosseous Anesthesia for Permanent Tooth Extraction Under GA in Pediatric Dental Treatment
A study testing Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia in people with No Condition, Assessment of Healthy Volunteers, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- No Condition, Assessment of Healthy Volunteers
- What is being tested?
- Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Aug 2025to 6 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - Children between 6 and 12 years old, belonging to the category of ASA I or II according to the 'American Society of Anaesthesiologists'
- Children who are cooperative enough for pre- and post-operative measurements
- Children who are not allergic to components of local anaesthesia
- Children who need at least one extraction of a FPM
- Children without a hematological condition
- Children who haven't taken painkillers 48 hours before the procedure
- Patients who need a treatment under general anaesthesia (nasal intubation) due to polycaries/fear/anxiety.
- Able to obtain a written consent from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes
Who cannot join
- - Treatment with a laryngeal mask
- If a traumatic extraction is needed, this patient is excluded from the study
- Children who do not meet the inclusion criteria
- Deviation in the pain relief protocol
- Parents/child don't speak Dutch
- Patients with missing data during the procedure/follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Sivaprakash Rajasekharan, BDS,MSc,PhD, +3293324008, siva.rajasekharan@uzgent.be
Jeroen Vandenbulcke, +329 332 69 42, jeroen.vandenbulcke@uzgent.be
About this study
Official title: The Effectiveness of Intra-osseous Anaesthesia in Reducing Immediate and Delayed Post-operative Complications Associated With the Extraction of First Permanent Molars Under General Anaesthesia: A Randomised Controlled Trial
The investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. This sometimes causes children to bite themselves without realizing it, which can make them upset when they wake up. In this study, the investigators are testing a special technique called intra-osseous anesthesia, which numbs only the tooth and not the surrounding soft tissues. The investigators hope this will reduce pain after surgery without causing numbness or accidental biting. Children in the study will be randomly placed into one of two groups: one group will receive this special anesthesia before the tooth is removed, and the other group will not. Before and after the procedure, the investigators will ask some short questions and observe the participants to check for pain, anxiety, or confusion. The parents of the participants will also receive a short online questionnaire to fill out the day after the procedure. The goal is to find out if this method helps children wake up more comfortably, feel less pain, and avoid side effects. This could improve how dentists care for children during dental treatments in the future.
Read the detailed description
To investigate whether the administration of intra-osseous local anesthesia (Quicksleeper 5) to children during general anesthesia prior to the extraction of a first permanent molar has an effect on the immediate and delayed postoperative delirium, anxiety and pain in the child.
Intra-osseous anesthesia consists of 3 major steps:
- Limited superficial anesthesia of the mucosa at the level of the tooth to be treated/extracted
- Perforation of the bone by means of a rotating needle movement
- Injection of the local anesthetic directly into the bone The operator (AG) will administer the intra-osseous anesthesia just before the tooth(s) are extracted. The extractions will always be performed at the end of the dental treatment.
A permanent molar must be removed from the child and this will be done under general anesthesia. Previous scientific studies have shown that when the dentist also administers local anesthesia during general anesthesia for tooth removal, children suffer from side effects of the local anesthesia. These side effects include numbness and lip or cheek biting. This can make them extra agitated when waking up from general anesthesia.
This intra-osseous anesthesia technique only anesthetizes the tooth. As a result, the child should not experience the above-mentioned side effects or to a lesser extent. In this study,The investigators want to investigate this effect. The advantage of this technique is that the child is expected to need little or no painkillers after the operation compared to the current procedure.
On the day of the procedure, upon arrival at the hospital, three short questionnaires will be administered regarding anxiety and pain. One questionnaire is observational, for the other two he investigators ask a little cooperation from the patient. This concerns the FLACC (Face, Legs, Activity, Cry, Consolability), VAS (Visual Analogue Scale) and CFSS-DS (Children's Fear Survey Schedule - Dental Scale).
If the patient is randomly assigned to the group that will receive local anaesthetic, this will be administered intra-osseously with the Quicksleeper 5 just before the tooth(s) is/are removed. The local anaesthetic that will be used is articaine 4% with epinephrine 1/100,000, this is a standard local anaesthetic in dentistry, the good and efficient effect of which has long been demonstrated.
Group 1 will receive local anaesthesia intra-osseously and group 2 will not. There is no further distinction between the groups.
The time at which the local anaesthetic is administered and the time at which the procedure is over will be noted.
After the procedure, the same questionnaires will be administered at set times as before the procedure. The patient does not have to stay in the hospital longer than normal for these questionnaires. The FLACC will be administered after 10/30/60/120 min, the VAS when the patient is able to speak and after 120 min, the CFSS-DS after 120 min and the delirium flowchart is an observational measurement that will be performed 5 min after spontaneously opening the eyes. The day after the procedure, the parents/guardian will be asked to answer one more questionnaire of approximately 20 questions via a QR code received.
- Being tested
- Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia
- Keywords
- Intra-osseous anesthesia, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesiaOther
Intra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5.
| Study group | Role | What they receive |
|---|---|---|
| intra osseous administration of local anesthesia during general anesthesia | Experimental | Intra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5. Receives: Other: Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia |
| Control group | No intervention | Normal procedure: no local anesthesia for the extraction of a first permanent molar during general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium in the child (flowchart)
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative delirium in the child. Postoperative delirium will be assessed 5 min after spontaneous eye opening using a validated flowchart
Measured: 5 minutes after spontaneous eye opening
Pre- and postoperative pain in the child (Visual Analogue Scale - VAS)
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at a fixed time after the procedure (after 120 minutes) using the validated VAS (Visual Analogue Scale) scale. Upon arrival at the hospital, the preoperative VAS will be taken.
The scale consists of a line of numbers from 0 (left side of the line) to 10 (right side of the line). The higher the number, the more pain, so a worse outcome.
Measured: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
Pre- and postoperative pain in the child (Face-Legs-Activity-Cry-Consolability Scale)
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at fixed times after the procedure (after 10/30/60/120 minutes) using the validated FLACC (Face-Legs-Activity-Cry-Consolability Scale) scales. Upon arrival at the hospital, the preoperative FLACC will be taken.
The scale consists of 5 scores assigned by an observer based on child's behavior/attitude. The sum of these determines the pain. 0 is no pain, 10 is intense pain. The higher the score, the outcome is worse.
Measured: Preoperative: arrival at the hospital, postoperative: after 10,30,60,120 minutes
Pre- and postoperative anxiety in the child (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale)
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative anxiety in the child. Postoperative anxiety will be assessed at a fixed time after the procedure (after 120 minutes) using a validated scale (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale). The scale consists of 15 questions with a score from 1 till 5. A score of 15 in total means no anxiety, a higher score means more dental anxiety/fear, so a worse outcome.
Measured: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
Secondary outcomes (1)
presence of postoperative side effects related to local anesthesia
the presence of postoperative side effects related to local anesthesia (bite wounds, numbness, postoperative bleeding, vomiting, nausea, etc.) will be evaluated.
After 24 hours, parents will be asked to complete the Quality of Recovery15 (QoR-15) digitally (qr-code). This is a validated scale.
Measured: 10 minutes up to 24 hours 10, 30, 60, 120 minutes after waking up (VAS - Visual Analogue Scale, FLACC - Face, Legs, Activity, Cry and Consolability, CFSS-DS- Children's Fear Survey Schedule - Dental Subscale questionnaire). After 24 hours: QoR-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start14 Aug 2025
- Primary completion5 May 2027 (estimated)
- Study completion6 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition, Assessment of Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloë Sterkens, Principal investigator, Equal Lifelong Oral Health for All Research Group, Paediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108439
- Sponsor's protocol ID
- ONZ-2025-0166
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD must be shared as anonymized or pseudonymized information. Data transfer must be conducted under Ghent University Hospital conditions, with legal experts drafting and reviewing the agreement (https://hiruz.be/cu/). Additionally, any data containing personal information requires approval from the Ethics Committee before transfer.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Intra-osseous Anaesthesia in Reducing Immediate and Delayed Post-operative Complications Associated With the Extraction of First Permanent Molars Under General Anaesthesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07108439
- Acronym / sponsor ID
- ONZ-2025-0166
- Keywords
- Intra-osseous anesthesia, pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 7 Aug 2025 (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 investigators are doing a study to see if a new way of giving local anesthesia during dental surgery can help children feel better after having a tooth removed under general anesthesia (when they are fully asleep). Normally, dentists give numbing medicine that can leave the lips or cheeks numb. This sometimes causes children to bite themselves without realizing it, which can make them upset when they wake up. In this study, the investigators are testing a special technique called intra-osseous anesthesia, which numbs only the tooth and not the surrounding soft tissues. The investigators hope this will reduce pain after surgery without causing numbness or accidental biting. Children in the study will be randomly placed into one of two groups: one group will receive this special anesthesia before the tooth is removed, and the other group will not. Before and after the procedure, the investigators will ask some short questions and observe the participants to check for pain, anxiety, or confusion. The parents of the participants will also receive a short online questionnaire to fill out the day after the procedure. The goal is to find out if this method helps children wake up more comfortably, feel less pain, and avoid side effects. This could improve how dentists care for children during dental treatments in the future.
Detailed description
To investigate whether the administration of intra-osseous local anesthesia (Quicksleeper 5) to children during general anesthesia prior to the extraction of a first permanent molar has an effect on the immediate and delayed postoperative delirium, anxiety and pain in the child.
Intra-osseous anesthesia consists of 3 major steps:
- Limited superficial anesthesia of the mucosa at the level of the tooth to be treated/extracted
- Perforation of the bone by means of a rotating needle movement
- Injection of the local anesthetic directly into the bone The operator (AG) will administer the intra-osseous anesthesia just before the tooth(s) are extracted. The extractions will always be performed at the end of the dental treatment.
A permanent molar must be removed from the child and this will be done under general anesthesia. Previous scientific studies have shown that when the dentist also administers local anesthesia during general anesthesia for tooth removal, children suffer from side effects of the local anesthesia. These side effects include numbness and lip or cheek biting. This can make them extra agitated when waking up from general anesthesia.
This intra-osseous anesthesia technique only anesthetizes the tooth. As a result, the child should not experience the above-mentioned side effects or to a lesser extent. In this study,The investigators want to investigate this effect. The advantage of this technique is that the child is expected to need little or no painkillers after the operation compared to the current procedure.
On the day of the procedure, upon arrival at the hospital, three short questionnaires will be administered regarding anxiety and pain. One questionnaire is observational, for the other two he investigators ask a little cooperation from the patient. This concerns the FLACC (Face, Legs, Activity, Cry, Consolability), VAS (Visual Analogue Scale) and CFSS-DS (Children's Fear Survey Schedule - Dental Scale).
If the patient is randomly assigned to the group that will receive local anaesthetic, this will be administered intra-osseously with the Quicksleeper 5 just before the tooth(s) is/are removed. The local anaesthetic that will be used is articaine 4% with epinephrine 1/100,000, this is a standard local anaesthetic in dentistry, the good and efficient effect of which has long been demonstrated.
Group 1 will receive local anaesthesia intra-osseously and group 2 will not. There is no further distinction between the groups.
The time at which the local anaesthetic is administered and the time at which the procedure is over will be noted.
After the procedure, the same questionnaires will be administered at set times as before the procedure. The patient does not have to stay in the hospital longer than normal for these questionnaires. The FLACC will be administered after 10/30/60/120 min, the VAS when the patient is able to speak and after 120 min, the CFSS-DS after 120 min and the delirium flowchart is an observational measurement that will be performed 5 min after spontaneously opening the eyes. The day after the procedure, the parents/guardian will be asked to answer one more questionnaire of approximately 20 questions via a QR code received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra osseous administration of local anesthesia during general anesthesia | Experimental | Other: Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesiaIntra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5. |
| Control group | No intervention | –Normal procedure: no local anesthesia for the extraction of a first permanent molar during general anesthesia |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- - Children between 6 and 12 years old, belonging to the category of ASA I or II according to the 'American Society of Anaesthesiologists'
- Children who are cooperative enough for pre- and post-operative measurements
- Children who are not allergic to components of local anaesthesia
- Children who need at least one extraction of a FPM
- Children without a hematological condition
Key exclusion criteria (6 listed)
- - Treatment with a laryngeal mask
- If a traumatic extraction is needed, this patient is excluded from the study
- Children who do not meet the inclusion criteria
- Deviation in the pain relief protocol
- Parents/child don't speak Dutch
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 |
|---|---|---|
| Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesiaIntra osseous administration of articain 4% 1/100 000 during general anesthesia for the extraction of a first permanent molar. The administration will be done with Quicksleeper 5. | Other | intra osseous administration of local anesthesia during general anesthesia |
Primary outcome
postoperative delirium in the child (flowchart)
Time frame: 5 minutes after spontaneous eye opening
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative delirium in the child. Postoperative delirium will be assessed 5 min after spontaneous eye opening using a validated flowchart
Pre- and postoperative pain in the child (Visual Analogue Scale - VAS)
Time frame: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at a fixed time after the procedure (after 120 minutes) using the validated VAS (Visual Analogue Scale) scale. Upon arrival at the hospital, the preoperative VAS will be taken. The scale consists of a line of numbers from 0 (left side of the line) to 10 (right side of the line). The higher the number, the more pain, so a worse outcome.
Pre- and postoperative pain in the child (Face-Legs-Activity-Cry-Consolability Scale)
Time frame: Preoperative: arrival at the hospital, postoperative: after 10,30,60,120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative pain in the child. Pre-and postoperative pain will be assessed at fixed times after the procedure (after 10/30/60/120 minutes) using the validated FLACC (Face-Legs-Activity-Cry-Consolability Scale) scales. Upon arrival at the hospital, the preoperative FLACC will be taken. The scale consists of 5 scores assigned by an observer based on child's behavior/attitude. The sum of these determines the pain. 0 is no pain, 10 is intense pain. The higher the score, the outcome is worse.
Pre- and postoperative anxiety in the child (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale)
Time frame: Preoperative: upon arrival at the hospital Postoperative: after 120 minutes
to investigate whether the administration of intra-osseous local anaesthesia (Quicksleeper 5, an electronically controlled intra-osseous anaesthesia injection system) to children during general anaesthesia prior to the extraction of a first permanent molar (FPM) has an effect on immediate and later postoperative anxiety in the child. Postoperative anxiety will be assessed at a fixed time after the procedure (after 120 minutes) using a validated scale (CFSS-DS - Children's Fear Survey Schedule - Dental Subscale). The scale consists of 15 questions with a score from 1 till 5. A score of 15 in total means no anxiety, a higher score means more dental anxiety/fear, so a worse outcome.
1 secondary outcome
presence of postoperative side effects related to local anesthesia
Time frame: 10 minutes up to 24 hours 10, 30, 60, 120 minutes after waking up (VAS - Visual Analogue Scale, FLACC - Face, Legs, Activity, Cry and Consolability, CFSS-DS- Children's Fear Survey Schedule - Dental Subscale questionnaire). After 24 hours: QoR-15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. The IPD must be shared as anonymized or pseudonymized information. Data transfer must be conducted under Ghent University Hospital conditions, with legal experts drafting and reviewing the agreement (https://hiruz.be/cu/). Additionally, any data containing personal information requires approval from the Ethics Committee before transfer.
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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.
Chloë Sterkens principal investigator
Equal Lifelong Oral Health for All Research Group, Paediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of intra-osseous local anesthesia before the extraction of a first permanent molar under general anesthesia in people with No Condition, Assessment of Healthy Volunteers, run by University Hospital, Ghent at 1 site in Belgium.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sivaprakash Rajasekharan, BDS,MSc,PhD (+3293324008, siva.rajasekharan@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium in the child (flowchart) (time frame: 5 minutes after spontaneous eye opening). 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 3 Oct 2025.