Dental Pulp DiseasesNCT05944341
Articaine Efficiency in Pulpectomy of Children With Irreversible Pulpitis Under the Age of Four
A study testing articaine hydrochloride 4% with epinephrine 1:100 000 and Lidocaine hydrochloride 2% with epinephrine 1:100 000 in people with Dental Pulp Diseases, run by Minia University at 1 site in Egypt.
Trial summary
A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. Read more about this study
- Who is it for?
- Ages 36 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Diseases
- What is being tested?
- articaine hydrochloride 4% with epinephrine 1:100 000 and Lidocaine hydrochloride 2% with epinephrine 1:100 000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 15 Jul 2023
- 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 36 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
- Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
- Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis
Who cannot join
- Molars with unrestorable crowns
- Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmad Elheeny
Minya, Minya Governorate, 61111
Ahmad Elheeny, PhD, 00201064257135, ahmedelheeny@mu.edu.eg
About this study
Official title: Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial
A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.
The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)
- Conditions
- Dental Pulp Diseases
- Being tested
- articaine hydrochloride 4% with epinephrine 1:100 000, Lidocaine hydrochloride 2% with epinephrine 1:100 000
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
articaine hydrochloride 4% with epinephrine 1:100 000Drug
Local anesthetic agent
Lidocaine hydrochloride 2% with epinephrine 1:100 000Drug
Local anesthetic agent
| Study group | Role | What they receive |
|---|---|---|
| Articaine | Experimental | Not described Receives: Drug: articaine hydrochloride 4% with epinephrine 1:100 000; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
| Lidocaine | Active comparator | Not described Receives: Drug: articaine hydrochloride 4% with epinephrine 1:100 000; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face, Legs, Activity, Cry, Consolability pain scale
its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jun 2023
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp DiseasesStudies of the same condition, open and under way.
- More trials run by Minia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944341
- Sponsor's protocol ID
- 778
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 13 Jul 2023
- 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 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Articaine Success in Pulpectomy of Primary Molars With Irreversible Pulpitis in Children Under Four Years: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05944341
- Acronym / sponsor ID
- 778
- Conditions
- Dental Pulp Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 13 Jul 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.
A two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. The participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia.
The direct observation tool FLACC was considered to assess pain severity. The behavior was assessed during pulpectomy procedures using the Frankl behavior rating scale (FBRS)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine | Experimental | Drug: articaine hydrochloride 4% with epinephrine 1:100 000, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
| Lidocaine | Active comparator | Drug: articaine hydrochloride 4% with epinephrine 1:100 000, Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000 |
Who may qualify
- Ages
- 36 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy 36-47 month-children (ASA class I or II) weighing at least 15 kilograms
- Children should be intellectually fit, and cooperative, with no behavior or communication abnormalities
- Presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis
Key exclusion criteria (2 listed)
- Molars with unrestorable crowns
- Molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
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 |
|---|---|---|
| articaine hydrochloride 4% with epinephrine 1:100 000Local anesthetic agent | Drug | Articaine, Lidocaine |
| Lidocaine hydrochloride 2% with epinephrine 1:100 000Local anesthetic agent | Drug | Articaine, Lidocaine |
Primary outcome
Face, Legs, Activity, Cry, Consolability pain scale
Time frame: up to 24 hours
its scores range from None/mild pain scores 0-3 Moderate pain scores 4-6 Severe pain scores 7-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing articaine hydrochloride 4% with epinephrine 1:100 000 and Lidocaine hydrochloride 2% with epinephrine 1:100 000 in people with Dental Pulp Diseases, run by Minia University at 1 site in Egypt.
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 2 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Face, Legs, Activity, Cry, Consolability pain scale (time frame: up to 24 hours). 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 Jul 2023.