Endodontic InflammationCOQNCT03802305
Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis
A study testing computerized intraosseous technique (Quicksleeper™) and loco-regional anesthesia (IANB technique) in people with Endodontic Inflammation, run by Nantes University Hospital at 1 site in France.
Trial summary
The irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endodontic Inflammation
- What is being tested?
- computerized intraosseous technique (Quicksleeper™) and loco-regional anesthesia (IANB technique)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 17 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- real irreversible pulpitis of a mandibular molar in dental emergency consultation at the Nantes hospital
- Healthy patient without medical history (ASA 1), without treatment for heart rate distress (anti arrhythmic, beta-blocking drug)
- Major and covered by the social security
- Informed consent
Who cannot join
- ASA > 1
- Pregnant and breastfeeding women
- Minors
- Adults under guardianships
- Adults deprived of freedom
- Impossibility to obtain for informed consent
Show all 19Show fewer
- Allergy to anesthetic components
- Contraindication of vasoconstrictor
- Angle closure glaucoma
- Pheochromocytomas
- Bisphosphonate IV
- Irradiated patient (upper respiratory and gastrointestinal tract cancer)
- Contraindication with Mono-amino oxidase inhibitors
- Acute apical periodontitis
- Pulpitis on wisdom teeth
- Vital teeth with fixed prosthesis
- Active periodontal disease
- Local anatomic difficulty
- No reference tooth for vitality dental test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis
The irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The latter represents a real challenge, since inflammation may decrease its action. To mitigate this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites risk reported with IANB) other anesthesias are proposed. In particular the computerized intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However, according to the observers, a mild to severe tachycardia have been reported.
Very few valid clinical trials exists on the subject, most being realized with systems of intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first to analyze the variations of the cardiovascular parameters into two groups of anesthesia: locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side effects, operating consequences of both techniques. This study should provide better data about potential risk with computerized intraosseous technique such has Quicksleeper ™ system in healthy or cardiovascular risk patient.
Read the detailed description
When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:
- Anamnesis: acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate toward the ear and/or jaw, exacerbated by cold or hot.
- Clinical exams: positive vitality tests (electric test and cold pressor test)
- Further examination (radiography)
The inclusion and exclusion criteria will be checked and the informed consent of the patient will be taken. The patient is then randomized in one of the group (experimental or control). He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care. A monitoring of cardiac parameters is made during the care at defined moment.
The patient evaluates his pain himself with the VAS (Visual Analog Score), before the intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™ handpiece but different specific needles.
Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
- Conditions
- Endodontic Inflammation
- Being tested
- computerized intraosseous technique (Quicksleeper™), loco-regional anesthesia (IANB technique)
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized intraosseous technique (Quicksleeper™)Device
The anesthetic solution is administered with a specific equipment allowing the injection step by step:
- anesthesia of the interdental papilla,
- positioning of the needle and perforating of the interdental space,
- Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment.
loco-regional anesthesia (IANB technique)Device
The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.
| Study group | Role | What they receive |
|---|---|---|
| Computerized intraosseous technique (Quicksleeper™) | Experimental | patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved. Receives: Device: computerized intraosseous technique (Quicksleeper™) |
| loco-regional anesthesia (IANB technique) | Active comparator | patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers. Receives: Device: loco-regional anesthesia (IANB technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.
- 3 successive values of heart rate similar to those registered before injection.
- 3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.
Measured: at day 0, from T0 minute to T14 minutes
Secondary outcomes (2)
Compare the pain of the patient between the two anesthetic techniques
Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable)
Measured: 3 days
Compare the possible postoperative course between the 2 anesthetic techniques
The postoperative course will be evaluated using a post-operative table to be completed by the patient at Day + 1, Day + 2 and Day + 3. Collection of information by phone call to the patient. The presence or absence of the following item is measured : pain after waking up, swelling, hematoma, seepage, higher tooth sensation, bite, possibility of feeding, mouth opening limitation.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Mar 2019
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endodontic InflammationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802305
- Sponsor's protocol ID
- RC18_0268
- Acronym
- COQ
- Status last verified
- Jun 2022
- First submitted
- 19 Dec 2018
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.
PubMed 37209243Laham A, Clouet R, Del Valle GA, Gaudin A, Prud'homme T. Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial. Trials. 2022 Dec 5;23(1):979. doi: 10.1186/s13063-022-06915-4.
PubMed 36471427
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis
- ClinicalTrials.gov ID
- NCT03802305
- Acronym / sponsor ID
- COQ / RC18_0268
- Conditions
- Endodontic Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 14 Jan 2019 (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 irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The latter represents a real challenge, since inflammation may decrease its action. To mitigate this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites risk reported with IANB) other anesthesias are proposed. In particular the computerized intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However, according to the observers, a mild to severe tachycardia have been reported.
Very few valid clinical trials exists on the subject, most being realized with systems of intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first to analyze the variations of the cardiovascular parameters into two groups of anesthesia: locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side effects, operating consequences of both techniques. This study should provide better data about potential risk with computerized intraosseous technique such has Quicksleeper ™ system in healthy or cardiovascular risk patient.
Detailed description
When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:
- Anamnesis: acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate toward the ear and/or jaw, exacerbated by cold or hot.
- Clinical exams: positive vitality tests (electric test and cold pressor test)
- Further examination (radiography)
The inclusion and exclusion criteria will be checked and the informed consent of the patient will be taken. The patient is then randomized in one of the group (experimental or control). He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care. A monitoring of cardiac parameters is made during the care at defined moment.
The patient evaluates his pain himself with the VAS (Visual Analog Score), before the intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™ handpiece but different specific needles.
Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)
| Arm | Type | Receives |
|---|---|---|
| Computerized intraosseous technique (Quicksleeper™) | Experimental | Device: computerized intraosseous technique (Quicksleeper™)patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved. |
| loco-regional anesthesia (IANB technique) | Active comparator | Device: loco-regional anesthesia (IANB technique)patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- real irreversible pulpitis of a mandibular molar in dental emergency consultation at the Nantes hospital
- Healthy patient without medical history (ASA 1), without treatment for heart rate distress (anti arrhythmic, beta-blocking drug)
- Major and covered by the social security
- Informed consent
Key exclusion criteria (19 listed)
- ASA > 1
- Pregnant and breastfeeding women
- Minors
- Adults under guardianships
- Adults deprived of freedom
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 |
|---|---|---|
| computerized intraosseous technique (Quicksleeper™)The anesthetic solution is administered with a specific equipment allowing the injection step by step: * anesthesia of the interdental papilla, * positioning of the needle and perforating of the interdental space, * Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment. | Device | Computerized intraosseous technique (Quicksleeper™) |
| loco-regional anesthesia (IANB technique)The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen. | Device | loco-regional anesthesia (IANB technique) |
Primary outcome
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.
Time frame: at day 0, from T0 minute to T14 minutes
* 3 successive values of heart rate similar to those registered before injection. * 3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.
2 secondary outcomes
Compare the pain of the patient between the two anesthetic techniques
Time frame: 3 days
Compare the possible postoperative course between the 2 anesthetic techniques
Time frame: 3 days
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 28 Jun 2022.
- Derived from this study: PubMed 37209243Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.
- Derived from this study: PubMed 36471427Laham A, Clouet R, Del Valle GA, Gaudin A, Prud'homme T. Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial. Trials. 2022 Dec 5;23(1):979. doi: 10.1186/s13063-022-06915-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized intraosseous technique (Quicksleeper™) and loco-regional anesthesia (IANB technique) in people with Endodontic Inflammation, run by Nantes University Hospital at 1 site 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 4 inclusion and 19 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 28 Jun 2022. 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 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?
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event. (time frame: at day 0, from T0 minute to T14 minutes). 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 NCT03802305, which also lists 2 linked publications.
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 28 Jun 2022.