Restorative Dental Treatment by Buccal Infiltration AnaesthesiaNCT06353815
Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block
A study testing 4% articaine infiltration in people with Restorative Dental Treatment by Buccal Infiltration Anaesthesia, run by Cairo University.
Trial summary
Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Restorative Dental Treatment by Buccal Infiltration Anaesthesia
- What is being tested?
- 4% articaine infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2025
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical Criteria:
- Children aged between 6 years and 9 years having:
- Mandibular first permanent molar with simple caries not involving pulp showing the following criteria: A. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. B. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.
- Radiographic criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption
Who cannot join
- • Uncooperative children.
- Children with systemic disease.
- Lack of informed consent by the child patient's parent.
- Refusal of participation.
- Allergy from anesthetic agent.
- Acute infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block for Restorative Dental Treatment in Mandibular First Permanent Molars: A Randomized Clinical Tria
Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars
- Being tested
- 4% articaine infiltration
- Keywords
- buccal infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% articaine infiltrationOther
Two injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues .
| Study group | Role | What they receive |
|---|---|---|
| Group I (Experimental group) 4% articaine infiltration | Experimental | Not described Receives: Other: 4% articaine infiltration |
| Group II (Control group) 4% articaine inferior alveolar nerve block | Active comparator | Not described Receives: Other: 4% articaine infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of local anesthesia
Operator will record the LA as Successful if the scheduled restorative treatment was completed with standard treatment management strategies after administration of the trial anaesthetic. If treatment could not be continued after 10 minutes from when the LA was first administered, and the full 1.8 ml cartridge of the trial anaesthetic had been used, then the LA was considered unsuccessful
Measured: 10 minutes
Secondary outcomes (1)
Child behavior during treatment
Doaa Moustafa: he patient's behavior will be evaluated for pain perception during treatment using the SEM scale (Appendix 3: SEM scale ). The SEM scale is an objective pain [10:04 pm, 31/3/2024] Doaa Moustafa: assessment scale with scores ranging from 1 to 4, illustrating comfort to severe discomfort based on sounds, eye, motor parameters
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startJul 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restorative Dental Treatment by Buccal Infiltration AnaesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353815
- Sponsor's protocol ID
- anaesthetic efficacy
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block for Restorative Dental Treatment in Mandibular First Permanent Molars: A Randomized Clinical Tria
- ClinicalTrials.gov ID
- NCT06353815
- Acronym / sponsor ID
- anaesthetic efficacy
- Keywords
- buccal infiltration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Experimental group) 4% articaine infiltration | Experimental | Other: 4% articaine infiltration |
| Group II (Control group) 4% articaine inferior alveolar nerve block | Active comparator | Other: 4% articaine infiltration |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Clinical Criteria:
- No sign of radiolucency in periapical or furcation area.
- No widening of PDL space or loss of lamina dura continuity.
- No evidence of internal/external pathologic root resorption
Key exclusion criteria (6 listed)
- • Uncooperative children.
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 |
|---|---|---|
| 4% articaine infiltrationTwo injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues . | Other | Group I (Experimental group) 4% articaine infiltration, Group II (Control group) 4% articaine inferior alveolar nerve block |
Primary outcome
Success of local anesthesia
Time frame: 10 minutes
Operator will record the LA as Successful if the scheduled restorative treatment was completed with standard treatment management strategies after administration of the trial anaesthetic. If treatment could not be continued after 10 minutes from when the LA was first administered, and the full 1.8 ml cartridge of the trial anaesthetic had been used, then the LA was considered unsuccessful
1 secondary outcome
Child behavior during treatment
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing 4% articaine infiltration in people with Restorative Dental Treatment by Buccal Infiltration Anaesthesia, 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 9 Apr 2024. 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 Doaa Moustafa, bachelor's degree (01064174546, Doaa.moustafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of local anesthesia (time frame: 10 minutes). 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 9 Apr 2024.