Pain, ProceduralNCT05427903
Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis
A study testing Cryotherapy and Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine in people with Pain, Procedural, run by Minia University at 1 site in Egypt.
Trial summary
The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- Cryotherapy and Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2022to 1 Jul 2022
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged above 18 years
- Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis
Who cannot join
- Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
- Presence of paresthesia
- Presence of psychological problems
- Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Minia University
Minya
Omar Ahmed, EG135.30708112400351@nies-edu.org
About this study
Official title: Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial
The study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.
- Conditions
- Pain, Procedural
- Being tested
- Cryotherapy, Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Ice packs application for 5 minutes after IANB injection
Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrineProcedure or surgery
Buccal infiltration after IANB
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Not described Receives: Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine |
| IANB plus buccal infiltration local anesthesia | Experimental | Not described Receives: Procedure: Cryotherapy |
| IANB | Active comparator | Not described Receives: Procedure: Cryotherapy; Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.
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 posted22 Jun 2022
- Study start4 Mar 2022
- Primary completion18 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 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
- NCT05427903
- Sponsor's protocol ID
- 602
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 22 Jun 2022
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Approaches in Enhancing the Efficacy of Inferior Alveolar Nerve Block During Treatment of Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: A Randomized Parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT05427903
- Acronym / sponsor ID
- 602
- Conditions
- Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 18 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 22 Jun 2022 (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 study is designed as a randomized parallel controlled trial with three groups. Participants aged above 18 years with the first permanent molars with symptomatic signs of irreversible pulpitis will be randomly assigned into 3 groups. The first group (experimental group) will be injected with 4% articaine 1:100.000 epinephrine (inferior alveolar nerve block) will be anesthetized using 4% articaine 1:100.000 plus cryotherapy application, and the second group (experimental group) will be anaesthetised with IANB plus buccal infiltration. For the third group (control group), the mandibular molars will be anaesthetized using epinephrine using the inferior alveolar nerve block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine |
| IANB plus buccal infiltration local anesthesia | Experimental | Procedure: Cryotherapy |
| IANB | Active comparator | Procedure: Cryotherapy, Procedure: Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged above 18 years
- Presence of at least one mandibular first permanent molar, with signs and symptoms of irreversible pulpititis
Key exclusion criteria (4 listed)
- Participants with a history of taking medications that could interfere with the action of the anaesthetic solutions
- Presence of paresthesia
- Presence of psychological problems
- Taking analgesics or other medications that would alter the inflammatory response of the pulp or provide analgesia 12 h pre-operatively
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 |
|---|---|---|
| CryotherapyIce packs application for 5 minutes after IANB injection | Procedure or surgery | IANB, IANB plus buccal infiltration local anesthesia |
| Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrineBuccal infiltration after IANB | Procedure or surgery | Cryotherapy, IANB |
Primary outcome
Pain assessment
Time frame: up to 24 hours
verbal rating scale (VRS) withh the following scores: Score 0: no pain, Score 1: mild pain, Score 2: moderate pain, and Score 3: severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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 Cryotherapy and Buccal local anesthetic infiltration using articaine 4% 1:100000 epinephrine in people with Pain, Procedural, 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 2 inclusion and 4 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 22 Jun 2022. 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?
Contact Ahmad Elheeny, PhD (00201064257135, ahmedelheeny@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (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 22 Jun 2022.