Anesthesia, LocalNCT03130855
Comparison Between Efficiency of Inferior Alveolar Nerve Block and Buccal Infiltration Techniques Using Articaine 4% 1:100000
A study testing inferior alveolar nerve block with 4% articaine and buccal infiltration with 4% articaine in people with Anesthesia, Local, run by Cairo University.
Trial summary
This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- inferior alveolar nerve block with 4% articaine and buccal infiltration with 4% articaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2017to 1 Aug 2017
- 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
- Healthy volunteers accepted
- Child
A-Inclusion Criteria:
- first dental visit.
- cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 6 to 8 years suffering from one or more deep carious lesions in their primary molars seeking treatment.
- Restorable molars with stainless steel crowns.
B-Exclusion Criteria:
- medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
- signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
- presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
- parents or guardians who refuse participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Buccal Infiltration Technique Compared to Inferior Alveolar Nerve Block Technique for Alleviation of Intraoperative Pain During Pulpal Treatment of Mandibular Primary Molars: A Randomized Controlled Clinical Trial.
This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment.
patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale).
the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.
- Conditions
- Anesthesia, Local
- Being tested
- inferior alveolar nerve block with 4% articaine, buccal infiltration with 4% articaine
- Keywords
- pediatric patients, articaine local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior alveolar nerve block with 4% articaineDrug
an anesthetic technique using 4% articaine anesthetic solution
buccal infiltration with 4% articaineDrug
anesthetic technique using 4% articaine anesthetic solution
| Study group | Role | What they receive |
|---|---|---|
| inferior alveolar nerve block with 4% articaine | Experimental | inferior alveolar nerve block using 4% articaine anesthetic solution Receives: Drug: inferior alveolar nerve block with 4% articaine |
| buccal infiltration with 4% articaine | Active comparator | buccal infiltration using 4% articaine anesthetic solution Receives: Drug: buccal infiltration with 4% articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain experienced by child during pulpal treatment
sound-eye-motor
Measured: one week
Secondary outcomes (2)
time needed for numbness
stop watch
Measured: one week
pain experienced by the child due to needle prick
Wong Baker facial pain scale
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start15 May 2017 (estimated)
- Primary completion1 Jul 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Sherif Ahmed Abo El Abbas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130855
- Sponsor's protocol ID
- articaine
- Status last verified
- May 2017
- First submitted
- 2 Apr 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Infiltration Technique Compared to Inferior Alveolar Nerve Block Technique for Alleviation of Intraoperative Pain During Pulpal Treatment of Mandibular Primary Molars: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03130855
- Acronym / sponsor ID
- articaine
- Conditions
- Anesthesia, Local
- Keywords
- pediatric patients, articaine local anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 1 Jul 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 27 Apr 2017 (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.
This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment.
patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale).
the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inferior alveolar nerve block with 4% articaine | Experimental | Drug: inferior alveolar nerve block with 4% articaineinferior alveolar nerve block using 4% articaine anesthetic solution |
| buccal infiltration with 4% articaine | Active comparator | Drug: buccal infiltration with 4% articainebuccal infiltration using 4% articaine anesthetic solution |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| inferior alveolar nerve block with 4% articainean anesthetic technique using 4% articaine anesthetic solution | Drug | inferior alveolar nerve block with 4% articaine |
| buccal infiltration with 4% articaineanesthetic technique using 4% articaine anesthetic solution | Drug | buccal infiltration with 4% articaine |
Primary outcome
pain experienced by child during pulpal treatment
Time frame: one week
sound-eye-motor
2 secondary outcomes
time needed for numbness
Time frame: one week
pain experienced by the child due to needle prick
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing inferior alveolar nerve block with 4% articaine and buccal infiltration with 4% articaine in people with Anesthesia, Local, 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?
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 10 May 2017. 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 omar sherif abo el abbas, bachelor (01210965669, omarsherif15@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain experienced by child during pulpal treatment (time frame: one week). 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 10 May 2017.