Local Anesthetic ComplicationNCT04812639
Buccal Infiltration Technique Compared to Inferior Alveolar Technique
A study testing Buccal infiltration technique and Inferior alveolar nerve block technique in people with Local Anesthetic Complication, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to compare the efficacy of the buccal infiltration technique with inferior alveolar nerve block technique for alleviation of intraoperative pain during pulpal treatment of second mandibular primary molars using 4% Articaine 1:100000. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthetic Complication
- What is being tested?
- Buccal infiltration technique and Inferior alveolar nerve block technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Dec 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 7 to 8.
- Medically free child ASA I or ASA II according to the American Society of anesthesiologist.
- Restorable bilateral deep carious lower primary second molars.
- Normal radiographic findings.
Who cannot join
- 1- Uncooperative child (rating 1 or 2 on the Frankl behavior scale). 2- Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
- 3- Radiographic signs of abscess, bone loss, internal or external root resorption was evident.
- 4- Parents or guardians refused participating in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Manial
hany M Saber, Associate Professor, 01225519667, drhanysaber@yahoo.com
About this study
Official title: Buccal Infiltration Technique in Comparison to the Inferior Alveolar Nerve Block Technique for Anesthetizing Mandibular Primary Molars During Pulpal Treatment
This study was conducted to compare the efficacy of the buccal infiltration technique with inferior alveolar nerve block technique for alleviation of intraoperative pain during pulpal treatment of second mandibular primary molars using 4% Articaine 1:100000.
The study started with 22 cooperative medically free patients aging 7 to 8 years old seeking treatment for bilateral deep carious mandibular second primary molars with no previous history of irreversible pulpitis, swelling, sinus tract or tooth mobility.
Read more
Randomization was achieved when each candidate was instructed to pick an opaque and sealed envelope from two separate black and opaque boxes. First box contained two envelopes to identify the side on which the operator will perform the treatment. While the second box contained another two envelopes describing which anesthetic technique will be implemented with the previously chosen side.
After clinical and radiographic examination, the patient received the pulpal treatment under the identified side and injecting technique. Videotaping of the pulpal treatment procedure was initiated after numbness was experienced by the child.
A blind assessor was assigned to review the videos and fill in the SEM pain scale to identify the pain and level of discomfort experienced by the child during the pulpal treatment.
Read the detailed description
This study was a split mouth randomized controlled trial enrolling 22 patients from the diagnostic center in the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University. All participants met the following inclusion criteria:
- Cooperative children (rating four or three based on Frankl behavior scale) aging from seven to eight years.
- Medically free child categorized as ASA I or ASA II according to the American Society of anesthesiologist.
- Restorable bilateral deep carious lower primary second molars as shown in figure (1).
- Normal radiographic findings.
Preoperative periapical x-rays were done on the targeted molars to confirm their adherence to the eligibility criteria and to confirm their restorability.
Each participant was asked to pick an opaque and sealed envelope from two separate black and opaque boxes to randomly choose the operated technique and side on the first operating visit. By default the other technique will be implemented on the other side on the upcoming visit.
Proper psychological management and desensitization procedures were undertaken to prepare the patient for the treatment. Certain phrases were used to prepare the child for applying topical anesthetic gel and injecting the anesthetic agent in any given technique like "The magic water will be used to put the tooth to sleep".
The protocols followed for inferior alveolar nerve block and buccal infiltration techniques were according to Jones and Dean; 2016 and Tudeshchoie et al; 2013.
Caries removal and pulpal treatment were videotaped with both local anesthetic techniques. Caries was removed using a high speed contra with copious cooling and proper suction, complete deroofing and excavation to the coronal pulpal tissues, bleeding from canals was evaluated after the application of a wet cotton for two to four minutes, and then a cotton damped with formocresol was applied for two to four minutes, fixation and brown stumps had to be evident for applying the zinc oxide and eugenol dressing in the pulp chamber.
If any pain was felt during the procedure and the patient raised his/her left hand the procedure was immediately halted. If pulpal exposure was still not evident additional anesthesia was injected through the inferior alveolar nerve block technique since it is the gold standard for anesthetizing mandibular posterior teeth. While if pain was experienced after pulpal exposure few drops of anesthesia was injected intra-pulpally, in both cases and this was considered a failure in the anesthetic technique used.
After application of zinc oxide and eugenol cement, video recording was halted, zinc phosphate cement was then used to seal the coronal part of the tooth and then the tooth was covered with a preformed stainless steel crown.
Videos were then assessed by an assessor who was completely blinded from the technique of injection to fill in a printed (SEM) pain scale sheet for each technique with each participant.
Postoperative instructions were verbally stated to the parent/guardian regarding precautions towards lip biting due to lip numbness. The patient was dismissed, and after at least a week the patient would be recalled to operate on the contralateral side.
In order to ensure complete blindness of the statistician to the results of the local anesthetic techniques, the inferior alveolar nerve block technique (IANB) was designated as Treatment Group I and buccal infiltration technique (BI) was designated as Treatment Group II.
- Data measurement:
SEM Pain Scale was used to evaluate the intraoperative pain experienced during pulpal treatment of mandibular primary second molars with both local anesthetic techniques using articaine four percent solution.
- Conditions
- Local Anesthetic Complication
- Being tested
- Buccal infiltration technique, Inferior alveolar nerve block technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal infiltration techniqueOther
a technique for injecting local anesthetic solution in the buccal mucobuccal fold between the roots of the targeted tooth
Inferior alveolar nerve block techniqueOther
a technique for injecting local anesthetic solution to anesthetize the inferior alveolar nerve
| Study group | Role | What they receive |
|---|---|---|
| buccal infiltartion technique | Experimental | local anesthetic technique Receives: Other: Inferior alveolar nerve block technique |
| Inferior alveolar nerve block technique | Active comparator | local anesthetic technique Receives: Other: Buccal infiltration technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during pulpal treatment
Sound Eye Motor SEM Pain scale
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthetic ComplicationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 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
- Investigators
- Saber H Mohamed, Associate Professor, Study director, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812639
- Sponsor's protocol ID
- BI vs IANB
- Status last verified
- Jul 2022
- First submitted
- 14 Mar 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Infiltration Technique in Comparison to the Inferior Alveolar Nerve Block Technique for Anesthetizing Mandibular Primary Molars During Pulpal Treatment
- ClinicalTrials.gov ID
- NCT04812639
- Acronym / sponsor ID
- BI vs IANB
- Conditions
- Local Anesthetic Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 23 Mar 2021 (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 was conducted to compare the efficacy of the buccal infiltration technique with inferior alveolar nerve block technique for alleviation of intraoperative pain during pulpal treatment of second mandibular primary molars using 4% Articaine 1:100000.
The study started with 22 cooperative medically free patients aging 7 to 8 years old seeking treatment for bilateral deep carious mandibular second primary molars with no previous history of irreversible pulpitis, swelling, sinus tract or tooth mobility.
Randomization was achieved when each candidate was instructed to pick an opaque and sealed envelope from two separate black and opaque boxes. First box contained two envelopes to identify the side on which the operator will perform the treatment. While the second box contained another two envelopes describing which anesthetic technique will be implemented with the previously chosen side.
After clinical and radiographic examination, the patient received the pulpal treatment under the identified side and injecting technique. Videotaping of the pulpal treatment procedure was initiated after numbness was experienced by the child.
A blind assessor was assigned to review the videos and fill in the SEM pain scale to identify the pain and level of discomfort experienced by the child during the pulpal treatment.
Detailed description
This study was a split mouth randomized controlled trial enrolling 22 patients from the diagnostic center in the Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University. All participants met the following inclusion criteria:
- Cooperative children (rating four or three based on Frankl behavior scale) aging from seven to eight years.
- Medically free child categorized as ASA I or ASA II according to the American Society of anesthesiologist.
- Restorable bilateral deep carious lower primary second molars as shown in figure (1).
- Normal radiographic findings.
Preoperative periapical x-rays were done on the targeted molars to confirm their adherence to the eligibility criteria and to confirm their restorability.
Each participant was asked to pick an opaque and sealed envelope from two separate black and opaque boxes to randomly choose the operated technique and side on the first operating visit. By default the other technique will be implemented on the other side on the upcoming visit.
Proper psychological management and desensitization procedures were undertaken to prepare the patient for the treatment. Certain phrases were used to prepare the child for applying topical anesthetic gel and injecting the anesthetic agent in any given technique like "The magic water will be used to put the tooth to sleep".
The protocols followed for inferior alveolar nerve block and buccal infiltration techniques were according to Jones and Dean; 2016 and Tudeshchoie et al; 2013.
Caries removal and pulpal treatment were videotaped with both local anesthetic techniques. Caries was removed using a high speed contra with copious cooling and proper suction, complete deroofing and excavation to the coronal pulpal tissues, bleeding from canals was evaluated after the application of a wet cotton for two to four minutes, and then a cotton damped with formocresol was applied for two to four minutes, fixation and brown stumps had to be evident for applying the zinc oxide and eugenol dressing in the pulp chamber.
If any pain was felt during the procedure and the patient raised his/her left hand the procedure was immediately halted. If pulpal exposure was still not evident additional anesthesia was injected through the inferior alveolar nerve block technique since it is the gold standard for anesthetizing mandibular posterior teeth. While if pain was experienced after pulpal exposure few drops of anesthesia was injected intra-pulpally, in both cases and this was considered a failure in the anesthetic technique used.
After application of zinc oxide and eugenol cement, video recording was halted, zinc phosphate cement was then used to seal the coronal part of the tooth and then the tooth was covered with a preformed stainless steel crown.
Videos were then assessed by an assessor who was completely blinded from the technique of injection to fill in a printed (SEM) pain scale sheet for each technique with each participant.
Postoperative instructions were verbally stated to the parent/guardian regarding precautions towards lip biting due to lip numbness. The patient was dismissed, and after at least a week the patient would be recalled to operate on the contralateral side.
In order to ensure complete blindness of the statistician to the results of the local anesthetic techniques, the inferior alveolar nerve block technique (IANB) was designated as Treatment Group I and buccal infiltration technique (BI) was designated as Treatment Group II.
- Data measurement:
SEM Pain Scale was used to evaluate the intraoperative pain experienced during pulpal treatment of mandibular primary second molars with both local anesthetic techniques using articaine four percent solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buccal infiltartion technique | Experimental | Other: Inferior alveolar nerve block techniquelocal anesthetic technique |
| Inferior alveolar nerve block technique | Active comparator | Other: Buccal infiltration techniquelocal anesthetic technique |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 7 to 8.
- Medically free child ASA I or ASA II according to the American Society of anesthesiologist.
- Restorable bilateral deep carious lower primary second molars.
- Normal radiographic findings.
Key exclusion criteria (3 listed)
- 1- Uncooperative child (rating 1 or 2 on the Frankl behavior scale). 2- Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
- 3- Radiographic signs of abscess, bone loss, internal or external root resorption was evident.
- 4- Parents or guardians refused participating in the study.
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 |
|---|---|---|
| Buccal infiltration techniquea technique for injecting local anesthetic solution in the buccal mucobuccal fold between the roots of the targeted tooth | Other | Inferior alveolar nerve block technique |
| Inferior alveolar nerve block techniquea technique for injecting local anesthetic solution to anesthetize the inferior alveolar nerve | Other | buccal infiltartion technique |
Primary outcome
Pain during pulpal treatment
Time frame: up to one month
Sound Eye Motor SEM Pain scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- 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.
Saber H Mohamed, Associate Professor study director
Cairo U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal infiltration technique and Inferior alveolar nerve block technique in people with Local Anesthetic Complication, 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 4 inclusion and 3 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 2 Aug 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 abbas O Sherif, Master Degree holder (01210965669 ext. Manial, omar_aboelabbas0107@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during pulpal treatment (time frame: up to one month). 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 2 Aug 2022.