Anesthesia, LocalNCT03917121
Pain Control of Needle-free Versus Needle Injected Local Anesthesia for Pulpotomy of Upper Primary Molars in Children
A study testing Jet injector and Needle attached dental syringe in people with Anesthesia, Local, run by Cairo University.
Trial summary
This is a study that will be conducted on 6 to 8 years old children to compare the needle-less jet injector with the conventional needle attached syringe in terms of efficiency in controlling pain of local anesthetic infiltration and post-anesthetic pulpotomy of upper first primary molars. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Jet injector and Needle attached dental syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to May 2020
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy (Classified as American Society of Anesthesiologists/ ASA I)
- Vital deeply carious maxillary first primary molars indicated for pulpotomy
- No previous dental experience
- Cooperative behavior (rating 3 or 4 on Frankl Category Rating Scale
Who cannot join
- Refuse to give assent to participate or have parents/caregivers refusing to sign the informed consent form
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pain Control of Needle-less Jet Anesthesia Versus Conventional Infiltration Anesthesia for Pulpotomy of Maxillary Primary Molars in Children: A Randomized Controlled Trial
This is a study that will be conducted on 6 to 8 years old children to compare the needle-less jet injector with the conventional needle attached syringe in terms of efficiency in controlling pain of local anesthetic infiltration and post-anesthetic pulpotomy of upper first primary molars. The study tests a null hypothesis that states that there is no difference in pain control efficiency of the compared anesthetic techniques when used for the selected treatment procedure in the specified population.
Read the detailed description
- The conduct of this study is driven by the substantial advantages that are documented to be offered by jet anesthesia over needle injected anesthesia combined with the scarcity, heterogeneity, limitations and contradicting inconclusive results of previously conducted studies assessing the acceptance and anesthetic efficiency of jet injectors against conventional needle attached dental syringes in pediatric patients, particularly for pulpotomy of primary molars. Jet injection offers the opportunity to deliver local anesthesia without using a needle and hence helps to avoid all drawbacks associated with needle injection such as psychological distress; pain; inability to cope with dental treatment; prolonged chair-side time; avoidance of dental care; high clinician skills required for child management and needle-stick injuries. It also allows precise controlled dosing; fast delivery and onset of local anesthesia; absence of post-operative numbness and thus self-inflicted traumatic injuries; reduction of medical waste and cutting down of long-term costs on the clinician. However, the true adequacy of jet anesthesia necessary to complete dental treatment successfully and the acceptance of jet injection in a child patient is yet to be revealed through further research.
- This randomized controlled trial is to be performed on children attending the Diagnosis outpatient clinic in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt. Children will be screened via personal, medical and dental history taking from them and their parents/caregivers; clinical examination and radiographic examination to identify appropriateness for recruitment in the trial based on the pre-specified eligibility criteria. Legal guardians of eligible children will be informed of the trial aims, conditions and procedures in details and a written informed consent will be obtained from them upon agreement for their children to participate in the trial. A verbal assent will be also obtained from each potential participant following a simple explanation of the trial procedure.
- Based on the sample size to be calculated, a random allocation sequence will be computer generated and will be used to assign participants to the experimental group receiving jet anesthesia (group A) and the control group receiving conventional infiltration anesthesia (group B). The allocation sequence will be enclosed in sequentially numbered, opaque, sealed envelopes and disclosure of the randomization code to the principle investigator will be performed only upon allocation of each corresponding subject throughout the course of the trial.
- For each study group, participants will be introduced to the dental setting and dental instruments to be used and have the anesthetization and dental procedure simply explained while avoiding any anxiety-provoking words. Psychological behavior management techniques such as Tell-Show-Do, voice control, distraction and positive reinforcement will be used similarly for both study groups. Following delivery of anesthesia, pulpotomy of maxillary first primary molars will be performed.
- Throughout the treatment procedure, if rescue anesthesia was needed, it will be delivered by needle infiltration in both study groups and recorded.
- Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
- Definitive examination and diagnosis for determination of eligibility, anesthetization, treatment, outcome measurement and data collection procedures will be all performed by the principal investigator.
- The principal investigator will be responsible for managing any intervention-related harms encountered by participants, both medically and financially, following-up the participant whenever necessary and providing post-operative prevention and oral hygiene instructions.
- All examination charts and outcome sheets will be labelled each with a specific code unique to every individual participant. Participant personal information will be kept confidential in a secured limited access area. All data will be electronically backed-up and securely stored by the principal investigator. Statistical analysis and interpretation of the collected results will be performed.
- All study results are planned to be disclosed and communicated to the public via a written thesis that will be orally presented and discussed in a defense that is to be held in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, in the presence of a selected jury. A manuscript of the trial work is planned to be prepared and submitted for publication.
- Conditions
- Anesthesia, Local
- Being tested
- Jet injector, Needle attached dental syringe
- Keywords
- Jet anesthesia, Pressure anesthesia, Needle-free anesthesia, Needle-less anesthesia, Needle-free injection, Jet injection, Needle-less local anesthesia, Needle-less syringe, Needle infiltration anesthesia, Needle injection, Local infiltration anesthesia, Local anesthesia, Pulpotomy, Vital pulp therapy, Primary molars, Child patients, Pediatric patients, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jet injectorDevice
Also called Madajet XL needle-free injector, Needle-less syringe, Needle-less injector
- The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
- Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using Madajet XL injector as per the manufacturer's instructions.
- A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
- Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
- All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated.
Needle attached dental syringeDevice
- The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
- Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using standard needle-attached syringe in a classical local infiltration.
- A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
- Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
- All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Jet anesthesia | Experimental | Local infiltration anesthesia delivered using Madajet XL® (MADA Medical Products, Inc., Carlstadt, NJ, USA) needle-free jet injector Receives: Device: Jet injector |
| Conventional infiltration anesthesia | Active comparator | Local infiltration anesthesia delivered using 25 gauged short needle attached, 1.8 ml carpule loaded standard metal dental syringe Receives: Device: Needle attached dental syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during pulpotomy score on Faces Pain Scale-Revised, aggregated by mean
- Faces Pain Scale- Revised is a participant self-reported pain rating scale that consists of six line drawings of faces in different degrees of distress, scored along a 0-10 metric, measuring pain. The scale starts by a neutral face scored '0' representing no pain and ends with a frowning face scored '10' representing maximum pain. Scores increase in increments of 2.
- The scale will be explained to the participant who will then be asked to choose the face that represents how much pain he/she feels. The pain score corresponding to the chosen face will be recorded.
Measured: Immediately following completion of pulpotomy procedure
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
- Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
- The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
- Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
Measured: Immediately following removal of dentin caries and initial access to pulp
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
- Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
- The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
- Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
Measured: Immediately following pulp extirpation
Secondary outcomes (3)
Pain during injection score on Faces Pain Scale-Revised, aggregated by mean
- Faces Pain Scale- Revised is a participant self-reported pain rating scale that consists of six line drawings of faces in different degrees of distress, scored along a 0-10 metric, measuring pain. The scale starts by a neutral face scored '0' representing no pain and ends with a frowning face scored '10' representing maximum pain. Scores increase in increments of 2.
- The scale will be explained to the participant who will then be asked to choose the face that represents how much pain he/she feels. The pain score corresponding to the chosen face will be recorded.
Measured: Immediately following injection of local anesthesia
Pain during injection score on Sound Eye Motor scale, aggregated by mean
- Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1.
- The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest.
- Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
Measured: Immediately following injection of local anesthesia
Need for additional anesthesia, recorded as a binary (yes/no) outcome
Rescue anesthesia recorded by principal investigator
Measured: Immediately following completion of treatment for participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startAug 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Model description
- Parallel group trial with a 1:1 allocation ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Salah El-Dien Mohamed Ahmed, Cairo University
- Investigators
- Lobna S. Mohamed, B.D.S., Principal investigator, Cairo UniversityRanda Y. Abd Al Gawad, Ph.D., Study chair, Cairo UniversityMariam M. Aly, Ph.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917121
- Sponsor's protocol ID
- CEBD-CU-2019-04-05
- Status last verified
- Jul 2019
- First submitted
- 12 Apr 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control of Needle-less Jet Anesthesia Versus Conventional Infiltration Anesthesia for Pulpotomy of Maxillary Primary Molars in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03917121
- Acronym / sponsor ID
- CEBD-CU-2019-04-05
- Conditions
- Anesthesia, Local
- Keywords
- Jet anesthesia, Pressure anesthesia, Needle-free anesthesia, Needle-less anesthesia, Needle-free injection, Jet injection, Needle-less local anesthesia, Needle-less syringe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 16 Apr 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.
This is a study that will be conducted on 6 to 8 years old children to compare the needle-less jet injector with the conventional needle attached syringe in terms of efficiency in controlling pain of local anesthetic infiltration and post-anesthetic pulpotomy of upper first primary molars. The study tests a null hypothesis that states that there is no difference in pain control efficiency of the compared anesthetic techniques when used for the selected treatment procedure in the specified population.
Detailed description
- The conduct of this study is driven by the substantial advantages that are documented to be offered by jet anesthesia over needle injected anesthesia combined with the scarcity, heterogeneity, limitations and contradicting inconclusive results of previously conducted studies assessing the acceptance and anesthetic efficiency of jet injectors against conventional needle attached dental syringes in pediatric patients, particularly for pulpotomy of primary molars. Jet injection offers the opportunity to deliver local anesthesia without using a needle and hence helps to avoid all drawbacks associated with needle injection such as psychological distress; pain; inability to cope with dental treatment; prolonged chair-side time; avoidance of dental care; high clinician skills required for child management and needle-stick injuries. It also allows precise controlled dosing; fast delivery and onset of local anesthesia; absence of post-operative numbness and thus self-inflicted traumatic injuries; reduction of medical waste and cutting down of long-term costs on the clinician. However, the true adequacy of jet anesthesia necessary to complete dental treatment successfully and the acceptance of jet injection in a child patient is yet to be revealed through further research.
- This randomized controlled trial is to be performed on children attending the Diagnosis outpatient clinic in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt. Children will be screened via personal, medical and dental history taking from them and their parents/caregivers; clinical examination and radiographic examination to identify appropriateness for recruitment in the trial based on the pre-specified eligibility criteria. Legal guardians of eligible children will be informed of the trial aims, conditions and procedures in details and a written informed consent will be obtained from them upon agreement for their children to participate in the trial. A verbal assent will be also obtained from each potential participant following a simple explanation of the trial procedure.
- Based on the sample size to be calculated, a random allocation sequence will be computer generated and will be used to assign participants to the experimental group receiving jet anesthesia (group A) and the control group receiving conventional infiltration anesthesia (group B). The allocation sequence will be enclosed in sequentially numbered, opaque, sealed envelopes and disclosure of the randomization code to the principle investigator will be performed only upon allocation of each corresponding subject throughout the course of the trial.
- For each study group, participants will be introduced to the dental setting and dental instruments to be used and have the anesthetization and dental procedure simply explained while avoiding any anxiety-provoking words. Psychological behavior management techniques such as Tell-Show-Do, voice control, distraction and positive reinforcement will be used similarly for both study groups. Following delivery of anesthesia, pulpotomy of maxillary first primary molars will be performed.
- Throughout the treatment procedure, if rescue anesthesia was needed, it will be delivered by needle infiltration in both study groups and recorded.
- Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
- Definitive examination and diagnosis for determination of eligibility, anesthetization, treatment, outcome measurement and data collection procedures will be all performed by the principal investigator.
- The principal investigator will be responsible for managing any intervention-related harms encountered by participants, both medically and financially, following-up the participant whenever necessary and providing post-operative prevention and oral hygiene instructions.
- All examination charts and outcome sheets will be labelled each with a specific code unique to every individual participant. Participant personal information will be kept confidential in a secured limited access area. All data will be electronically backed-up and securely stored by the principal investigator. Statistical analysis and interpretation of the collected results will be performed.
- All study results are planned to be disclosed and communicated to the public via a written thesis that will be orally presented and discussed in a defense that is to be held in Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, in the presence of a selected jury. A manuscript of the trial work is planned to be prepared and submitted for publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group trial with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Jet anesthesia | Experimental | Device: Jet injectorLocal infiltration anesthesia delivered using Madajet XL® (MADA Medical Products, Inc., Carlstadt, NJ, USA) needle-free jet injector |
| Conventional infiltration anesthesia | Active comparator | Device: Needle attached dental syringeLocal infiltration anesthesia delivered using 25 gauged short needle attached, 1.8 ml carpule loaded standard metal dental syringe |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Apparently healthy (Classified as American Society of Anesthesiologists/ ASA I)
- Vital deeply carious maxillary first primary molars indicated for pulpotomy
- No previous dental experience
- Cooperative behavior (rating 3 or 4 on Frankl Category Rating Scale
Key exclusion criteria (1 listed)
- Refuse to give assent to participate or have parents/caregivers refusing to sign the informed consent form
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 |
|---|---|---|
| Jet injectorAlso: Madajet XL needle-free injector, Needle-less syringe, Needle-less injector* The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection. * Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using Madajet XL injector as per the manufacturer's instructions. * A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration. * Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points. * All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated. | Device | Jet anesthesia |
| Needle attached dental syringe* The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection. * Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using standard needle-attached syringe in a classical local infiltration. * A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration. * Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points. * All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated. | Device | Conventional infiltration anesthesia |
Primary outcome
Pain during pulpotomy score on Faces Pain Scale-Revised, aggregated by mean
Time frame: Immediately following completion of pulpotomy procedure
* Faces Pain Scale- Revised is a participant self-reported pain rating scale that consists of six line drawings of faces in different degrees of distress, scored along a 0-10 metric, measuring pain. The scale starts by a neutral face scored '0' representing no pain and ends with a frowning face scored '10' representing maximum pain. Scores increase in increments of 2. * The scale will be explained to the participant who will then be asked to choose the face that represents how much pain he/she feels. The pain score corresponding to the chosen face will be recorded.
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
Time frame: Immediately following removal of dentin caries and initial access to pulp
* Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1. * The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest. * Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
Pain during pulpotomy score on Sound Eye Motor scale, aggregated by mean
Time frame: Immediately following pulp extirpation
* Sound Eye Motor scale is a clinician-reported pain rating scale that considers three types of physical observations- sound, ocular and motor- and scores each along a 1-4 subscale, measuring pain.'1' is designated as comfort (represents no pain) and '4' is designated as painful (represents maximum pain). Scores increase in increments of 1. * The participant will be observed and a score will be given by the assessor on each of the three subscales. The three scores given will be summed to obtain the total pain score at a specific time point of interest. * Primary pain assessment on Sound Eye Motor scale will be performed by principal investigator and independent duplicate pain assessment on the same scale will be performed by study director.
3 secondary outcomes
Pain during injection score on Faces Pain Scale-Revised, aggregated by mean
Time frame: Immediately following injection of local anesthesia
Pain during injection score on Sound Eye Motor scale, aggregated by mean
Time frame: Immediately following injection of local anesthesia
Need for additional anesthesia, recorded as a binary (yes/no) outcome
Time frame: Immediately following completion of treatment for participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Lobna S. Mohamed, B.D.S. principal investigator
Cairo University
Randa Y. Abd Al Gawad, Ph.D. study chair
Cairo University
Mariam M. Aly, Ph.D. study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Jet injector and Needle attached dental syringe in people with Anesthesia, Local, 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 4 inclusion and 1 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 24 Jul 2019. 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 Lobna S. Mohamed, B.D.S. (+20 10 6412 3124, lobna_mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during pulpotomy score on Faces Pain Scale-Revised, aggregated by mean (time frame: Immediately following completion of pulpotomy procedure). 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 24 Jul 2019.