Anesthesia, LocalNCT04458142
Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration
A study testing Single buccal infiltration in people with Anesthesia, Local, run by Cairo University.
Trial summary
Everyday practice in dentistry is based on giving the painless injection and achieving adequate local anesthesia. Various techniques of reducing injection pain in children can be broadly categorized as psychological and physical. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Single buccal infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Mar 2021
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children from 6 to 9 years of age requiring extraction in two different quadrants in maxillary arch.
- Children who demonstrate positive or definitely positive behavior during pretreatment evaluation ranking 3 or 4 in the Frankl scale.
- Rating 3: Positive Acceptance of treatment; at times cautious; willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively.
- Rating 4 :Definitely positive Good rapport with the dentists interested in the dental procedures, laughing and enjoying.
- Child must give assent prior to participation, as well as parental informed written consent.
Who cannot join
- Medically and mentally compromised children.
- Children with a history of prolonged bleeding, platelet disorders, hypersensitivity,
- History of significant behavior management problems.
- Patients having active sites of pathosis in the area of injection.
About this study
Official title: Comparison of The Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration Using 4% Articaine During Extraction of Primary Maxillary Molar Teeth: A Randomized Controlled Trial Split Mouth Design Study
Everyday practice in dentistry is based on giving the painless injection and achieving adequate local anesthesia. Various techniques of reducing injection pain in children can be broadly categorized as psychological and physical. The psychological approach includes behavior management techniques, physical means and other recent techniques such as computer controlled anesthesia, electronic dental anesthesia, and so forth. However, none of these techniques have been successful in eliminating pain, fear and anxiety in children.
Direct palatal injection technique is difficult to administer without significant pain or discomfort since there is little tissue space at these sites between the mucosa and the underlying periosteum. Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.
Read more
The desirable method to evade pain during palatal injection is just not to have one.
Maxillary molars removal without palatal or multiple injections is possible due to relatively thin porous bone of posterior buccal maxilla that facilitates the diffusion of local anesthetic.
Read the detailed description
The provision of intraoral palatal anesthesia can be potentially more painful for the patient when compared to other sites of the oral cavity, as palatal tissues are tightly bound to the hard palate with limited tissue space between it and the periosteum . As the injection is given, pressure builds up within the palatal tissues causing pain.
Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.
The desirable method to evade pain during palatal injection is just not to have one. So studies was made to evaluate the single buccal injection and its efficiency during extraction of maxillary teeth. The relatively thin porous bone of posterior buccal maxilla facilitates the diffusion of local anesthetic,as well as articaine can diffuse through soft and hard tissues more reliably than other LA so that maxillary buccal infiltration of articaine provides palatal soft tissue anesthesia.Therefore single injection eliminates the need for multiple painful injections.
- Conditions
- Anesthesia, Local
- Being tested
- Single buccal infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single buccal infiltrationOther
painless technique for palatal anesthesia,single injection,single puncture given
| Study group | Role | What they receive |
|---|---|---|
| Single buccal infiltration using 4%articaine | Experimental | Dryness the site of injection then application of topical anesthetic gel(2% benzocaine).
Injecting by a small amount of solution in the superficial mucosa. After a few seconds, the needle was slowly advanced in the mucobuccal fold toward the apex of the molar and 1.8 ml of 4% articaine using short 30-gauge needle was slowly given.
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed by inquiring about the area of numbness from the participant, no pain during pricking the palatal mucosa. The cases in which palatal anesthesia will not be reported by the patient will be given supplemental palatal infiltration with 0.2 to 0.3 mL articaine.
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique. Receives: Other: Single buccal infiltration |
| Buccal and intrapapillary infiltration using 4%articaine | Active comparator | Dryness the site of injection then application of topical anesthetic gel(2% benzocaine) Injecting a small amount of solution in the superficial mucosa,then needle will slowly advanced in the mucobuccal fold toward the apex of the molar and 1.5 ml of 4% articaine was slowly given. The remaining 0.3ml solution will be given equally into the distal, mesial intrapapillary and palatal sites respectively until blanching of the palate is observed extending more than halfway along the palatal gingival margin.
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed.
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique. Receives: Other: Single buccal infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior pain assessment during anesthesia and extraction
FLACC Behavioral Pain Scale will be used for assessment during anaesthesia and extraction. This scale consists of 5 categories face, leg, activity, cry, consolabilty. Each category is scored on the 0-2 scale, which results in a total score of 0-10.
Measured: Intraoperative
Subjective self report pain assessment after anesthesia and extraction
Second subjective self report assesment will be done using Wong-baker scale after the anaesthsia and extraction.It consist of a set of cartoon faces with varying facial expression ranging from smile/laughter to tears.• Each face has a numerical value ranging from 0-5.
Measured: intraoperative
physiological record of pain after anesthesia and extraction
phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadil Ahmed Mohamed Ahmed ELSafty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458142
- Sponsor's protocol ID
- 14422017496954
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol, informed consent, clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration Using 4% Articaine During Extraction of Primary Maxillary Molar Teeth: A Randomized Controlled Trial Split Mouth Design Study
- ClinicalTrials.gov ID
- NCT04458142
- Acronym / sponsor ID
- 14422017496954
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 7 Jul 2020 (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.
Everyday practice in dentistry is based on giving the painless injection and achieving adequate local anesthesia. Various techniques of reducing injection pain in children can be broadly categorized as psychological and physical. The psychological approach includes behavior management techniques, physical means and other recent techniques such as computer controlled anesthesia, electronic dental anesthesia, and so forth. However, none of these techniques have been successful in eliminating pain, fear and anxiety in children.
Direct palatal injection technique is difficult to administer without significant pain or discomfort since there is little tissue space at these sites between the mucosa and the underlying periosteum. Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.
The desirable method to evade pain during palatal injection is just not to have one.
Maxillary molars removal without palatal or multiple injections is possible due to relatively thin porous bone of posterior buccal maxilla that facilitates the diffusion of local anesthetic.
Detailed description
The provision of intraoral palatal anesthesia can be potentially more painful for the patient when compared to other sites of the oral cavity, as palatal tissues are tightly bound to the hard palate with limited tissue space between it and the periosteum . As the injection is given, pressure builds up within the palatal tissues causing pain.
Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.
The desirable method to evade pain during palatal injection is just not to have one. So studies was made to evaluate the single buccal injection and its efficiency during extraction of maxillary teeth. The relatively thin porous bone of posterior buccal maxilla facilitates the diffusion of local anesthetic,as well as articaine can diffuse through soft and hard tissues more reliably than other LA so that maxillary buccal infiltration of articaine provides palatal soft tissue anesthesia.Therefore single injection eliminates the need for multiple painful injections.
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 using 4%articaine | Experimental | Other: Single buccal infiltrationDryness the site of injection then application of topical anesthetic gel(2% benzocaine). Injecting by a small amount of solution in the superficial mucosa. After a few seconds, the needle was slowly advanced in the mucobuccal fold toward the apex of the molar and 1.8 ml of 4% articaine using short 30-gauge needle was slowly given. Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed by inquiring about the area of numbness from the participant, no pain during pricking the palatal mucosa. The cases in which palatal anesthesia will not be reported by the patient will be given supplemental palatal infiltration with 0.2 to 0.3 mL articaine. After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique. |
| Buccal and intrapapillary infiltration using 4%articaine | Active comparator | Other: Single buccal infiltrationDryness the site of injection then application of topical anesthetic gel(2% benzocaine) Injecting a small amount of solution in the superficial mucosa,then needle will slowly advanced in the mucobuccal fold toward the apex of the molar and 1.5 ml of 4% articaine was slowly given. The remaining 0.3ml solution will be given equally into the distal, mesial intrapapillary and palatal sites respectively until blanching of the palate is observed extending more than halfway along the palatal gingival margin. Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed. After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children from 6 to 9 years of age requiring extraction in two different quadrants in maxillary arch.
Key exclusion criteria (4 listed)
- Medically and mentally compromised children.
- Children with a history of prolonged bleeding, platelet disorders, hypersensitivity,
- History of significant behavior management problems.
- Patients having active sites of pathosis in the area of injection.
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 infiltrationpainless technique for palatal anesthesia,single injection,single puncture given | Other | Buccal and intrapapillary infiltration using 4%articaine, Single buccal infiltration using 4%articaine |
Primary outcome
Behavior pain assessment during anesthesia and extraction
Time frame: Intraoperative
FLACC Behavioral Pain Scale will be used for assessment during anaesthesia and extraction. This scale consists of 5 categories face, leg, activity, cry, consolabilty. Each category is scored on the 0-2 scale, which results in a total score of 0-10.
Subjective self report pain assessment after anesthesia and extraction
Time frame: intraoperative
Second subjective self report assesment will be done using Wong-baker scale after the anaesthsia and extraction.It consist of a set of cartoon faces with varying facial expression ranging from smile/laughter to tears.• Each face has a numerical value ranging from 0-5.
physiological record of pain after anesthesia and extraction
Time frame: intraoperative
phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Yes. study protocol, informed consent, clinical study report
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Single buccal infiltration 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?
The sponsor lists 5 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 7 Jul 2020. 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?
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?
Behavior pain assessment during anesthesia and extraction (time frame: Intraoperative). The study lists 3 primary outcomes in all. 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 7 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.