Symptomatic Irreversible PulpitisNCT05724862
Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques
A study testing Needle-less jet anaesthesia and Conventional Injection Anesthesia in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Needle-less jet anaesthesia and Conventional Injection Anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 18-50
- Males and females
- Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
- Patients accepting to participate in the trial
- Patients who can understand pain scale and can sign the informed consent
- Mature maxillary molars with symptomatic irreversible pulpitis
Who cannot join
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females
- Teeth with necrotic pulps
- Non-restorable or periodontally hopeless teeth
- Patients on analgesic or anti-inflammatory drugs 12 hours prior to treatment
- Patients allergic to any of the components of the anesthetic solution
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques in Patients With Symptomatic Irreversible Pulpitis in Maxillary Molars: A Randomized Clinical Trial
Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Besides, the level of anxiety was established as one of the most crucial predictors of dental anesthesia level.
Techniques and equipment such as topical anesthetic, cold spray, applying pressure, vibratory devices, distraction techniques, sedation medications, have been developed and utilized to reduce pain or fear of dental injections or increase the efficacy of anesthesia. However it is the sight and sensation of a needle that was found by almost 25% of patients to be extremely anxiety provoking stimuli in a survey to determine what dental patients truly fear.
Therefore, Needleless devices that were developed to provide anesthesia without injections would reduce patients' apprehension and anxiety levels resulting in a profound anesthesia for a proper duration of time
Read the detailed description
The aim of the study, treatment procedures, possible side effects and treatment alternatives will be explained to the patients. Patients will be asked to follow the general instructions and sign a printed informed consent. Patients will be asked to fill the outcomes data charts honestly and accurately.
- Eligible patients will be randomly divided into two equal groups according to randomization mechanism: Group 1 (Comfort-In Jet Anesthesia) and Group 2 (Local Infiltration Anesthesia)
- Pre-operative measures (for all groups):
- Medical and dental history will be obtained from all participants, clinical and radiographic evaluation for each tooth included in this study will be recorded.
- Clinical diagnosis of symptomatic irreversible pulpitis will be confirmed based on both subjective and objective findings.
- The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrolment.
- Pain scale chart will be explained to each participant in order to be used after administration of local anaesthesia.
- Intervention group (G1): Teeth will be anaesthetized using the Comfort-In Jet device by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally.
- Control group (G2): Teeth will be anaesthetized using conventional infiltration anaesthesia by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally.
- Each patient will record the level of discomfort during administration of anaesthesia in the pain scale chart (NRS).
- Profound pulpal anaesthesia will be checked using an electric pulp tester reading every one minute after anesthetic administration up to ten minutes.
- Teeth that fail to reach profound pulpal anaesthesia will receive a rescue dose of the same anaesthetic solution (4% Articaine) using the conventional injection technique, if needed, intra-ligamentary injection will be used followed by intra-pulpal anaesthesia in case of persistent pain.
- After confirming profound pulpal anaesthesia single visit root canal treatment will be performed.
- Access cavity preparation will be done using round burs and tapered diamond stones and patients will be asked to report any pain and/or discomfort during this step. The pain intensity will be recorded on the NRS.
- Teeth will be isolated with rubber dam and working length will be obtained by an apex locator and confirmed radiographically to be 0.5 to 1 mm from the radiographic apex.
- All canals will be prepared with crown down techniques using EdgeEndo rotary files depending on the initial size of the canals.
- Irrigation will be done using 2 ml of 2.5% NaOCl between each two successive files, then, all canals will have a final flush with 5 ml of 17% EDTA for 1 minute followed by 5 ml of distilled water, 5ml of 2.5% NaOCl and finally 5 ml of distilled water in order to remove any residual chemicals from canals.
- Pain incidence and intensity during mechanical preparation will also be reported by the patients and recorded on the NRS.
- After complete preparation canals will be dried and obturated in the same visit and teeth will be temporized.
- Patients will receive postoperative instructions, and will be allowed to call the operator in case of moderate or severe postoperative pain and if needed, an emergency visit will be scheduled.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Needle-less jet anaesthesia, Conventional Injection Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-less jet anaesthesiaDevice
Infiltration anesthesia without needle depending on injection pressure
Conventional Injection AnesthesiaDevice
Regular Infiltration local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Needle-less jet anaesthesia | Experimental | Infiltration anaesthesia without needle Receives: Device: Needle-less jet anaesthesia |
| Conventional injection anaesthesia | Active comparator | Regular infiltration anaesthesia Receives: Device: Conventional Injection Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra operative pain
Using NRS score
Measured: Up to One hour
Secondary outcomes (1)
Onset of pulpal anaesthesia
Electric pulp tester will be used to measure the time taken for gaining profound anesthesia
Measured: Up to Ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nader Ramsis, Cairo University
- Investigators
- Shaimaa I Bakry, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724862
- Sponsor's protocol ID
- 25-11-2022
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques in Patients With Symptomatic Irreversible Pulpitis in Maxillary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05724862
- Acronym / sponsor ID
- 25-11-2022
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 13 Feb 2023 (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.
Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Besides, the level of anxiety was established as one of the most crucial predictors of dental anesthesia level.
Techniques and equipment such as topical anesthetic, cold spray, applying pressure, vibratory devices, distraction techniques, sedation medications, have been developed and utilized to reduce pain or fear of dental injections or increase the efficacy of anesthesia. However it is the sight and sensation of a needle that was found by almost 25% of patients to be extremely anxiety provoking stimuli in a survey to determine what dental patients truly fear.
Therefore, Needleless devices that were developed to provide anesthesia without injections would reduce patients' apprehension and anxiety levels resulting in a profound anesthesia for a proper duration of time
Detailed description
The aim of the study, treatment procedures, possible side effects and treatment alternatives will be explained to the patients. Patients will be asked to follow the general instructions and sign a printed informed consent. Patients will be asked to fill the outcomes data charts honestly and accurately.
- Eligible patients will be randomly divided into two equal groups according to randomization mechanism: Group 1 (Comfort-In Jet Anesthesia) and Group 2 (Local Infiltration Anesthesia)
- Pre-operative measures (for all groups):
- Medical and dental history will be obtained from all participants, clinical and radiographic evaluation for each tooth included in this study will be recorded.
- Clinical diagnosis of symptomatic irreversible pulpitis will be confirmed based on both subjective and objective findings.
- The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrolment.
- Pain scale chart will be explained to each participant in order to be used after administration of local anaesthesia.
- Intervention group (G1): Teeth will be anaesthetized using the Comfort-In Jet device by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally.
- Control group (G2): Teeth will be anaesthetized using conventional infiltration anaesthesia by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally.
- Each patient will record the level of discomfort during administration of anaesthesia in the pain scale chart (NRS).
- Profound pulpal anaesthesia will be checked using an electric pulp tester reading every one minute after anesthetic administration up to ten minutes.
- Teeth that fail to reach profound pulpal anaesthesia will receive a rescue dose of the same anaesthetic solution (4% Articaine) using the conventional injection technique, if needed, intra-ligamentary injection will be used followed by intra-pulpal anaesthesia in case of persistent pain.
- After confirming profound pulpal anaesthesia single visit root canal treatment will be performed.
- Access cavity preparation will be done using round burs and tapered diamond stones and patients will be asked to report any pain and/or discomfort during this step. The pain intensity will be recorded on the NRS.
- Teeth will be isolated with rubber dam and working length will be obtained by an apex locator and confirmed radiographically to be 0.5 to 1 mm from the radiographic apex.
- All canals will be prepared with crown down techniques using EdgeEndo rotary files depending on the initial size of the canals.
- Irrigation will be done using 2 ml of 2.5% NaOCl between each two successive files, then, all canals will have a final flush with 5 ml of 17% EDTA for 1 minute followed by 5 ml of distilled water, 5ml of 2.5% NaOCl and finally 5 ml of distilled water in order to remove any residual chemicals from canals.
- Pain incidence and intensity during mechanical preparation will also be reported by the patients and recorded on the NRS.
- After complete preparation canals will be dried and obturated in the same visit and teeth will be temporized.
- Patients will receive postoperative instructions, and will be allowed to call the operator in case of moderate or severe postoperative pain and if needed, an emergency visit will be scheduled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle-less jet anaesthesia | Experimental | Device: Needle-less jet anaesthesiaInfiltration anaesthesia without needle |
| Conventional injection anaesthesia | Active comparator | Device: Conventional Injection AnesthesiaRegular infiltration anaesthesia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range 18-50
- Males and females
- Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
- Patients accepting to participate in the trial
- Patients who can understand pain scale and can sign the informed consent
Key exclusion criteria (6 listed)
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- Pregnant females
- Teeth with necrotic pulps
- Non-restorable or periodontally hopeless teeth
- Patients on analgesic or anti-inflammatory drugs 12 hours prior to treatment
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 |
|---|---|---|
| Needle-less jet anaesthesiaInfiltration anesthesia without needle depending on injection pressure | Device | Needle-less jet anaesthesia |
| Conventional Injection AnesthesiaRegular Infiltration local anesthesia | Device | Conventional injection anaesthesia |
Primary outcome
Intra operative pain
Time frame: Up to One hour
Using NRS score
1 secondary outcome
Onset of pulpal anaesthesia
Time frame: Up to Ten minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
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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.
Shaimaa I Bakry study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Needle-less jet anaesthesia and Conventional Injection Anesthesia in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Nader W Ramsis (01225321044, nader.wadie@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra operative pain (time frame: Up to One hour). 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 13 Feb 2023.