AnesthesiaNCT05221190
Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia
A study testing Single buccal infiltration and Inferior alveolar nerve block in people with Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Single buccal infiltration and Inferior alveolar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 3 Mar 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present.
- Children ranging in age from 5-8 years
Who cannot join
- .Allergies to local anesthetics.
- History of significant medical conditions.
- Children under any medications.
- Presence of abscess, sinus opening.
- Uncooperative children without access to or with difficulty accessing dental care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Effectiveness of Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia for the Extraction of Primary Mandibular Molars: A Randomized Controlled Study
This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.
Read the detailed description
Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance .
The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve.
Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children .
However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips .
An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .
- Conditions
- Anesthesia
- Being tested
- Single buccal infiltration, Inferior alveolar nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single buccal infiltrationProcedure or surgery
Also called Articaine buccal infiltration
injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.
Inferior alveolar nerve blockProcedure or surgery
Also called Lidocaine nerve block
Injection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Single buccal infiltration of articaine anesthesia | Experimental | The local anesthetic solution will be administered using single buccal infiltration with articaine anesthesia. Receives: Procedure: Single buccal infiltration |
| Inferior alveolar nerve block of lidocaine anesthesia | Active comparator | The anesthetic solution will be administered using inferior alveolar nerve block with lidocaine anesthesia. Receives: Procedure: Inferior alveolar nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intraoperative pain
Wong Baker Faces Pain Rating Scale consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears with numerical value from 0 to 5 where where zero indicates no pain and 5 indicate severe pain
Measured: through treatment completion, an average of 1 hour
Secondary outcomes (3)
intraoperative pain
Faces, Legs, Activity, Cry, and Consolability scale with score from 0 to 10 where zero indicates no pain and 10 indicate severe pain
Measured: through treatment completion, an average of 1 hour
The onset of the anesthetic effect
stopwatch
Measured: up to 24 hours
duration of the anesthetic effect
stopwatch
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 posted2 Feb 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa aly fouad elchaghaby, Cairo University
- Investigators
- marwa m elchaghaby, phd, Principal investigator, marwaaly2003@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221190
- Sponsor's protocol ID
- Anesthetic techniques
- Status last verified
- Nov 2022
- First submitted
- 3 Jan 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effectiveness of Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia for the Extraction of Primary Mandibular Molars: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05221190
- Acronym / sponsor ID
- Anesthetic techniques
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 2 Feb 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.
This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.
Detailed description
Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance .
The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve.
Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children .
However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips .
An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single buccal infiltration of articaine anesthesia | Experimental | Procedure: Single buccal infiltrationThe local anesthetic solution will be administered using single buccal infiltration with articaine anesthesia. |
| Inferior alveolar nerve block of lidocaine anesthesia | Active comparator | Procedure: Inferior alveolar nerve blockThe anesthetic solution will be administered using inferior alveolar nerve block with lidocaine anesthesia. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present.
- Children ranging in age from 5-8 years
Key exclusion criteria (5 listed)
- .Allergies to local anesthetics.
- History of significant medical conditions.
- Children under any medications.
- Presence of abscess, sinus opening.
- Uncooperative children without access to or with difficulty accessing dental care.
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 |
|---|---|---|
| Single buccal infiltrationAlso: Articaine buccal infiltrationinjecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth. | Procedure or surgery | Single buccal infiltration of articaine anesthesia |
| Inferior alveolar nerve blockAlso: Lidocaine nerve blockInjection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible. | Procedure or surgery | Inferior alveolar nerve block of lidocaine anesthesia |
Primary outcome
Assessment of intraoperative pain
Time frame: through treatment completion, an average of 1 hour
Wong Baker Faces Pain Rating Scale consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears with numerical value from 0 to 5 where where zero indicates no pain and 5 indicate severe pain
3 secondary outcomes
intraoperative pain
Time frame: through treatment completion, an average of 1 hour
The onset of the anesthetic effect
Time frame: up to 24 hours
duration of the anesthetic effect
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 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.
marwa m elchaghaby, phd principal investigator
marwaaly2003@yahoo.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single buccal infiltration and Inferior alveolar nerve block in people with Anesthesia, run by Cairo 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 5 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: finished, as of the sponsor's last update on 16 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of intraoperative pain (time frame: through treatment completion, an average of 1 hour). 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 16 Nov 2022.