PainNCT04303234
Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique
A study testing Artinibsa and Artpharma in people with Pain, run by Cairo University.
Trial summary
The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Artinibsa and Artpharma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Oct 2021
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8-10 years old
- Mentally capable of communication
- Cooperative children need restorative treatment
Who cannot join
- Medically compromised patient
- Primary teeth requiring pulpotomy or pulpectomy
- Parent or guardians who refuse participating in the study
Trial locations and contacts
No sites are listed yet.
Fatma Korany Ismail, Phd contact
About this study
Official title: Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial
The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.
Read the detailed description
Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.
- Conditions
- Pain
- Being tested
- Artinibsa, Artpharma
- Keywords
- Articaine, Infiltration technique, Restoration primary teeth, Intraoperative pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtinibsaOther
local anaesthetic solution with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains 4%Articaine 1:100000.
ArtpharmaOther
Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)
| Study group | Role | What they receive |
|---|---|---|
| Artinibsa | Active comparator | Powerful local anesthetic with short time for patients who can not tolerate normal doses of vasoconstrictor latency.
High lipid solubility gives a better diffusion through the soft tissue and bone being very effective in infiltrative techniques.
Duration:
Latency time: 2 minutes
Each mL contains:
4%Articaine 1:100000. Hydrochloride 40.00 mg, Epinephrine (D.C.I) 0.005 mg tartrate Receives: Other: Artinibsa |
| Artpharma | Experimental | Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg) Receives: Other: Artpharma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Pain: Wong Baker rating scale
Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.
Measured: During the procedure.
Secondary outcomes (3)
Onset of anesthesia
is measuring by using stop watch and the unite is minutes. the unit is : minutes
Measured: Immediately after the injection.
The sensation after injection
Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No)
Measured: Immediately after the injection.
Time of numbness disappear
Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No).
Measured: 2 hours postoperatively after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Hamed Hashem AL-Aidaros, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303234
- Sponsor's protocol ID
- CEBD-CU-2020-03-08
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 11 Mar 2020
- 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04303234
- Acronym / sponsor ID
- CEBD-CU-2020-03-08
- Conditions
- Pain
- Keywords
- Articaine, Infiltration technique, Restoration primary teeth, Intraoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 11 Mar 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.
The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.
Detailed description
Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artinibsa | Active comparator | Other: ArtinibsaPowerful local anesthetic with short time for patients who can not tolerate normal doses of vasoconstrictor latency. High lipid solubility gives a better diffusion through the soft tissue and bone being very effective in infiltrative techniques. Duration: Latency time: 2 minutes Each mL contains: 4%Articaine 1:100000. Hydrochloride 40.00 mg, Epinephrine (D.C.I) 0.005 mg tartrate |
| Artpharma | Experimental | Other: ArtpharmaIts a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg) |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 8-10 years old
- Mentally capable of communication
- Cooperative children need restorative treatment
Key exclusion criteria (3 listed)
- Medically compromised patient
- Primary teeth requiring pulpotomy or pulpectomy
- Parent or guardians who refuse participating in the study
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 |
|---|---|---|
| Artinibsalocal anaesthetic solution with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains 4%Articaine 1:100000. | Other | Artinibsa |
| ArtpharmaIts a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg) | Other | Artpharma |
Primary outcome
Intraoperative Pain: Wong Baker rating scale
Time frame: During the procedure.
Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.
3 secondary outcomes
Onset of anesthesia
Time frame: Immediately after the injection.
The sensation after injection
Time frame: Immediately after the injection.
Time of numbness disappear
Time frame: 2 hours postoperatively after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Fatma Korany Ismail, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Artinibsa and Artpharma in people with Pain, 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 3 inclusion and 3 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 11 Mar 2020. 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 Amani ALAidaros, Master (01004358665, amani.alaidaroos@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Pain: Wong Baker rating scale (time frame: During the procedure.). 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 11 Mar 2020.