Anesthesia, LocalNCT06201949
Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars
A study testing Articaine infiltration technique and Articaine nerve block technique in people with Anesthesia, Local, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Articaine infiltration technique and Articaine nerve block technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Mar 2023to 30 Jun 2023
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
- Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
- Patients whose parents will give their consent to participate
Who cannot join
- Children with any systemic disease or special health care.
- History of allergy to local anesthesia.
- Radiographic evidence of periapical or inter-radicular radiolucency
- Patients with previous negative dental experience.
- Presence of soft tissue lesions at the site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)
Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.
Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.
Read more
Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.
Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.
Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale
- Conditions
- Anesthesia, Local
- Being tested
- Articaine infiltration technique, Articaine nerve block technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine infiltration techniqueOther
infiltration will be performed with articaine and epinephrine 1/100 000 (Artinibsa, Inibsa, Barcelona, Spain) for all patients on their second pri-mary molar. The needle tip was placed in the buccal vestibule and then directed to the apex of the tooth and about one-third to one-fourth of the cartridge will be slowly discharged
Articaine nerve block techniqueOther
this technique will be performed with articaine and epinephrine 1/100 000 for all patients on their second primary molar with conventional technique inferior alveolar nerve block. The thumb will be placed on the occlusal surface of intended side and protruded toward the inner oblique ridge of ramus and then placed in touch with retromolar pad. The syringe will be directed between the two mandibular primary molars of opposite side and the needle will be pushed forward until hitting the bone, then the injection will be slowly done. After three to five minutes, treatment will be started, after numbness in the lower lip is achieved
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Other: Articaine infiltration technique |
| Control group | Active comparator | Not described Receives: Other: Articaine nerve block technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate
Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.
Measured: During procedure
change in pain level
Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.
Measured: During procedure
Secondary outcomes (1)
Adevrse events
The presence of any adverse events including infection, oral/tooth pain, patients will be seen after 24 hours to detect any lip/cheek biting and parasethia
Measured: After 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start16 Mar 2023
- Primary completion18 Jun 2023
- Study completion30 Jun 2023
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201949
- Sponsor's protocol ID
- 0636_2/2023
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06201949
- Acronym / sponsor ID
- 0636_2/2023
- Conditions
- Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jan 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.
Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.
Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.
Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.
Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.
Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Other: Articaine infiltration technique |
| Control group | Active comparator | Other: Articaine nerve block technique |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
- Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
- Patients whose parents will give their consent to participate
Key exclusion criteria (5 listed)
- Children with any systemic disease or special health care.
- History of allergy to local anesthesia.
- Radiographic evidence of periapical or inter-radicular radiolucency
- Patients with previous negative dental experience.
- Presence of soft tissue lesions at the site 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 |
|---|---|---|
| Articaine infiltration techniqueinfiltration will be performed with articaine and epinephrine 1/100 000 (Artinibsa, Inibsa, Barcelona, Spain) for all patients on their second pri-mary molar. The needle tip was placed in the buccal vestibule and then directed to the apex of the tooth and about one-third to one-fourth of the cartridge will be slowly discharged | Other | Test group |
| Articaine nerve block techniquethis technique will be performed with articaine and epinephrine 1/100 000 for all patients on their second primary molar with conventional technique inferior alveolar nerve block. The thumb will be placed on the occlusal surface of intended side and protruded toward the inner oblique ridge of ramus and then placed in touch with retromolar pad. The syringe will be directed between the two mandibular primary molars of opposite side and the needle will be pushed forward until hitting the bone, then the injection will be slowly done. After three to five minutes, treatment will be started, after numbness in the lower lip is achieved | Other | Control group |
Primary outcome
change in heart rate
Time frame: During procedure
Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.
change in pain level
Time frame: During procedure
Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.
1 secondary outcome
Adevrse events
Time frame: After 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 11 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articaine infiltration technique and Articaine nerve block technique in people with Anesthesia, Local, run by Hams Hamed Abdelrahman 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 3 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 11 Jan 2024. 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?
change in heart rate (time frame: During procedure). The study lists 2 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 11 Jan 2024.