Badly Decayed Lower First Primary Molars in ChildrenNCT03942991
Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars
A study testing articaine and Mepivacaine 2% Injection in people with Badly Decayed Lower First Primary Molars in Children, run by Cairo University.
Trial summary
parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Badly Decayed Lower First Primary Molars in Children
- What is being tested?
- articaine and Mepivacaine 2% Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2019
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-8 years.
- Medically fit (ASA I, II).
- Mentally capable of communication.
- Having a mandibular first primary molar tooth that require Extraction.
- Child must give assent prior to participation, as well as parental informed written consent.
- Body weight >20 kg.
- it should be the first dental treatment to the child
Who cannot join
- Medically and mentally compromised children.
- Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
- History of significant behavior management problems.
- Patients having active sites of pathosis in the area of injection.
- Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
- Patients allergic to Articaine and/or Mepivacaine and/or sulfur
About this study
Official title: Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study
parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.
- Being tested
- articaine, Mepivacaine 2% Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articaineDrug
Also called Artpharmadent
infiltration injection of 4%artpharmadent
Mepivacaine 2% InjectionDrug
Also called 2% Mepecaine-L
infiltration injection of 2% Mepecaine-L
| Study group | Role | What they receive |
|---|---|---|
| 2% Mepecaine-L | Active comparator | infiltration injection of 2% Mepivacaine Receives: Drug: Mepivacaine 2% Injection |
| 4% Artpharmadent | Experimental | infiltration injection of 4% Articaine Receives: Drug: articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-Operative Pain during Extraction
intraoperative pain will be measured using wong baker pain scale,The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain Face
Measured: Immediatly after etxraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Decayed Lower First Primary Molars in ChildrenStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadeen Hossam Eldin Hosny Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942991
- Sponsor's protocol ID
- 14422017496941
- Status last verified
- Aug 2019
- First submitted
- 2 May 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study
- ClinicalTrials.gov ID
- NCT03942991
- Acronym / sponsor ID
- 14422017496941
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 8 May 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.
parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% Mepecaine-L | Active comparator | Drug: Mepivacaine 2% Injectioninfiltration injection of 2% Mepivacaine |
| 4% Artpharmadent | Experimental | Drug: articaineinfiltration injection of 4% Articaine |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6-8 years.
- Medically fit (ASA I, II).
- Mentally capable of communication.
- Having a mandibular first primary molar tooth that require Extraction.
- Child must give assent prior to participation, as well as parental informed written consent.
Key exclusion criteria (6 listed)
- Medically and mentally compromised children.
- Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
- History of significant behavior management problems.
- Patients having active sites of pathosis in the area of injection.
- Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
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 |
|---|---|---|
| articaineAlso: Artpharmadentinfiltration injection of 4%artpharmadent | Drug | 4% Artpharmadent |
| Mepivacaine 2% InjectionAlso: 2% Mepecaine-Linfiltration injection of 2% Mepecaine-L | Drug | 2% Mepecaine-L |
Primary outcome
Intra-Operative Pain during Extraction
Time frame: Immediatly after etxraction
intraoperative pain will be measured using wong baker pain scale,The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain Face
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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.
Questions about this trial
What is this clinical trial studying?
A study testing articaine and Mepivacaine 2% Injection in people with Badly Decayed Lower First Primary Molars in Children, 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 7 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 29 Aug 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?
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?
Intra-Operative Pain during Extraction (time frame: Immediatly after etxraction). 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 29 Aug 2019.