PainSLEEPER-ONENCT04629924
Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection With Conventional Anesthesia
A study testing sleeper one and conventional technis in people with Pain, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
Trial summary
Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Pain
- What is being tested?
- sleeper one and conventional technis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Mar 2021to 24 Nov 2022
- 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written consent of one of the two parents (legal guardians) and the child,
- Child and parents (legal guardians) speaking French,
- Child covered by his parents' social security coverage,
- Child aged 4-8 years in temporary stable denture,
- Child in good general health (ASAI or II),
- Child cooperating in care in the vigilant state (cooperation evaluated with a Venham score) 0, 1, 2).
- Child with two temporary molars of the same type, 1st or 2nd molars, controlateral (fractional mouth test) belonging to different quadrants of the the same arch (pair of teeth 54-64, 55-65, 74-84 or 75-85) and each requiring a single equivalent conservative treatment under anaesthesia (ICDAS 3 to 6 carious lesions on teeth) vital).
Who cannot join
- They are declined at the scale of the subject and the tooth:
- Child having taken an analgesic treatment 24 hours before randomization,
- Child allergic to local anesthetics
- Child with at least one of the two temporary molars of the same pair (54-64, 55-65, 74-84 or 75-85) has inflammatory or infectious complications (symptomatology of irreversible pulpitis, clear radio image) and in front of this fact to make the object of a pulpectomy or avulsion :
- Molar presenting spontaneous pain outside of meals or continuous pain.
- Temporary molar whose radiographic examination reveals an enlargement of the space desmodontal, the presence of a radio-clear image at the furcation and/or the periapical regions, or even internal or external resorption.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Lille University Hospital
Lille, 59000
Nantes University Hospital
Nantes, 44000
Nice Hospital
Nice, 06000
Rennes University Hospital
Rennes, 35000
Toulouse university Hospital
Toulouse, 31000
About this study
Official title: Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection to a Conventional Anaesthesia by Infiltration on Temporary Molars
Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt.
(FPS-R).
Read more
The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard.
Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints
Specific monitoring modalities added by research include :
- Explanation of the study to each eligible child and his or her legal guardians
- Gathering the informed consent of the child and his or her legal guardians
- The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)
- Data collection during the two care sessions (maximum 15 days apart)
It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.
- Conditions
- Pain
- Being tested
- sleeper one, conventional technis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeper oneDevice
anesthesic injection with sleeper one device
conventional technisDevice
anesthesic injection with the conventional technic
| Study group | Role | What they receive |
|---|---|---|
| sleeper one | Experimental | Topical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont).
Osteocentral anesthesia performed with the SleeperOne® 5 system (Dental Hi Tec) loaded with Articaine 1/200000 carpule. Receives: Device: sleeper one; Device: conventional technis |
| conventional technique | Active comparator | Topical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont).
Anaesthesia using a conventional technique, i.e. a metal syringe loaded with Articaine 1/200000 carpule. Receives: Device: sleeper one; Device: conventional technis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient pain
intensity of pain felt by the patient according to the face scale.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start24 Mar 2021
- Primary completion28 Oct 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicentre, randomized, split-mouth, randomized controlled trial in which the experimental and control anesthetic systems will be randomly assigned to the teeth (randomization unit) of the tooth pair. controlerals considered in the same patient. This design allows a gain in power, each subject being its own witness without any carry-across effect, the two treatments being separated by one to two weeks ("split-mouth cross-over").
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629924
- Sponsor's protocol ID
- 20-AOI-06
- Acronym
- SLEEPER-ONE
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muller-Bolla M, Aiem E, Joseph C, Davit-Beal T, Marquillier T, Esclassan E, Delfosse C, Lopez S, Velly AM. Pain during primary molar local anaesthesia with SleeperOne5 computerized device versus conventional syringe: A randomized, split-mouth, crossover, controlled trial. Int J Paediatr Dent. 2024 Nov;34(6):891-905. doi: 10.1111/ipd.13189. Epub 2024 Apr 17.
PubMed 38629634
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection to a Conventional Anaesthesia by Infiltration on Temporary Molars
- ClinicalTrials.gov ID
- NCT04629924
- Acronym / sponsor ID
- SLEEPER-ONE / 20-AOI-06
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 16 Nov 2020 (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.
Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt.
(FPS-R).
The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard.
Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints
Specific monitoring modalities added by research include :
- Explanation of the study to each eligible child and his or her legal guardians
- Gathering the informed consent of the child and his or her legal guardians
- The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)
- Data collection during the two care sessions (maximum 15 days apart)
It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multicentre, randomized, split-mouth, randomized controlled trial in which the experimental and control anesthetic systems will be randomly assigned to the teeth (randomization unit) of the tooth pair. controlerals considered in the same patient. This design allows a gain in power, each subject being its own witness without any carry-across effect, the two treatments being separated by one to two weeks ("split-mouth cross-over").
| Arm | Type | Receives |
|---|---|---|
| sleeper one | Experimental | Device: sleeper one, Device: conventional technisTopical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont). Osteocentral anesthesia performed with the SleeperOne® 5 system (Dental Hi Tec) loaded with Articaine 1/200000 carpule. |
| conventional technique | Active comparator | Device: sleeper one, Device: conventional technisTopical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont). Anaesthesia using a conventional technique, i.e. a metal syringe loaded with Articaine 1/200000 carpule. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Written consent of one of the two parents (legal guardians) and the child,
- Child and parents (legal guardians) speaking French,
- Child covered by his parents' social security coverage,
- Child aged 4-8 years in temporary stable denture,
- Child in good general health (ASAI or II),
Key exclusion criteria (6 listed)
- Child having taken an analgesic treatment 24 hours before randomization,
- Child allergic to local anesthetics
- Child with at least one of the two temporary molars of the same pair (54-64, 55-65, 74-84 or 75-85) has inflammatory or infectious complications (symptomatology of irreversible pulpitis, clear radio image) and in front of this fact to make the object of a pulpectomy or avulsion :
- Molar presenting spontaneous pain outside of meals or continuous pain.
- Temporary molar whose radiographic examination reveals an enlargement of the space desmodontal, the presence of a radio-clear image at the furcation and/or the periapical regions, or even internal or external resorption.
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 |
|---|---|---|
| sleeper oneanesthesic injection with sleeper one device | Device | conventional technique, sleeper one |
| conventional technisanesthesic injection with the conventional technic | Device | conventional technique, sleeper one |
Primary outcome
patient pain
Time frame: 18 months
intensity of pain felt by the patient according to the face scale.
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 20 Mar 2023.
- Derived from this study: PubMed 38629634Muller-Bolla M, Aiem E, Joseph C, Davit-Beal T, Marquillier T, Esclassan E, Delfosse C, Lopez S, Velly AM. Pain during primary molar local anaesthesia with SleeperOne5 computerized device versus conventional syringe: A randomized, split-mouth, crossover, controlled trial. Int J Paediatr Dent. 2024 Nov;34(6):891-905. doi: 10.1111/ipd.13189. Epub 2024 Apr 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleeper one and conventional technis in people with Pain, run by Centre Hospitalier Universitaire de Nice at 5 sites in France.
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 7 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: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
patient pain (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629924, which also lists 1 linked publication.
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 20 Mar 2023.