Pain, PostoperativeNCT04221685
Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children
A study testing Artpharma and Artinibsa in people with Pain, Postoperative, run by Cairo University.
Trial summary
The aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Artpharma and Artinibsa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Dec 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-9 years.
- Children with maxillary primary molars indicated for extraction.
Who cannot join
- Children with medical conditions.
- Uncooperative children.
- Parents 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 Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial
The aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.
Read the detailed description
Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons
- Conditions
- Pain, Postoperative
- Being tested
- Artpharma, Artinibsa
- Keywords
- Articaine, Extraction primary teeth, Infiltration technique, Postoperative pain, Intraoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtpharmaOther
ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg
ArtinibsaOther
Powerful local anaesthetic 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:
Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg
| Study group | Role | What they receive |
|---|---|---|
| Artinibsa | Active comparator | Powerful local anaesthetic 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.4%Articaine 1:100000. Receives: Other: Artinibsa |
| Artpharma | Experimental | ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride,Epinephrine (D.C.I) (tartrate) 0.01 mg Receives: Other: Artpharma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative pain.
Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).
Measured: immediate
Secondary outcomes (3)
Pain during injection(success rate).
Pain during injection:is evaluated the success rate of anesthesia by using the visual analogue scale and measuring unite is categorical.
Measured: immediate
Onset of anesthesia.
onset of anesthesia:is measuring by using stop watch and the unit is minutes
Measured: Immediate
The sensation after injection.
The sensation after injection: is evaluated the effect of the anesthesia by checking mucous using the probe and measuring unite is binary (Yes or No).
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafedha Hashem Abdullah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221685
- Sponsor's protocol ID
- IOP Use Artp Vs Artin inf
- Status last verified
- Oct 2020
- First submitted
- 1 Jan 2020
- Last updated
- 8 Oct 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04221685
- Acronym / sponsor ID
- IOP Use Artp Vs Artin inf
- Conditions
- Pain, Postoperative
- Keywords
- Articaine, Extraction primary teeth, Infiltration technique, Postoperative pain, Intraoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 9 Jan 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 extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.
Detailed description
Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons
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 anaesthetic 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.4%Articaine 1:100000. |
| Artpharma | Experimental | Other: ArtpharmaArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride,Epinephrine (D.C.I) (tartrate) 0.01 mg |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6-9 years.
- Children with maxillary primary molars indicated for extraction.
Key exclusion criteria (3 listed)
- Children with medical conditions.
- Uncooperative children.
- Parents 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 |
|---|---|---|
| ArtpharmaArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg | Other | Artpharma |
| ArtinibsaPowerful local anaesthetic 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: Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg | Other | Artinibsa |
Primary outcome
Intraoperative pain.
Time frame: immediate
Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).
3 secondary outcomes
Pain during injection(success rate).
Time frame: immediate
Onset of anesthesia.
Time frame: Immediate
The sensation after injection.
Time frame: Immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Fatma Korany Ismail, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Artpharma and Artinibsa in people with Pain, Postoperative, 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 2 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 8 Oct 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 Hafedha Zain, Master (01114341678, hafedha.abdullah@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. (time frame: immediate). 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 8 Oct 2020.