Anesthesia, LocalPhase 4NCT04773236
Evaluation of Buffered Local Anesthesia in Dental Extraction.
A Phase 4 study testing sodium bicarbonate 8.4%, 2%lidocaine with 1:80.000 epinphrine and Mixing pen (onset buffering system) in people with Anesthesia, Local, run by University of Baghdad.
Trial summary
To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- sodium bicarbonate 8.4%, 2%lidocaine with 1:80.000 epinphrine and Mixing pen (onset buffering system)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2021to 22 Aug 2021
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give written, informed consent (both the subject and the legal guardian).
- Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this).
- 4.Be able to comprehend the verbal rating scale (instructions given to ascertain this).
- 5.upper premolars and molars extraction.
Who cannot join
- Patient under 18 years.
- pregnant women.
- patient with uncontrolled systemic disease that are contraindicated for dental extraction. 4- patient taking medication that interfere with the assessment of local anesthetic such as narcotics and antidepressants .
About this study
Official title: Evaluation of Buffered Local Anesthesia in Dental Extraction: A Randomized Clinical Study.
To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction.
Read the detailed description
The investigators will conduct a prospective, randomized, single-blinded study, the sample will include 100 patients (extraction) who need dental extraction of upper teeth (premolar and molar teeth). The predictor variable is the use of buffered 2% lidocaine with 1:80,000 adrenaline and non-buffered 2% lidocaine with 1:80,000 adrenaline. The patients will be randomly assigned into two groups of 50 patients each using Microsoft Excel 2016; the first group (study group) will undergo dental extraction after receiving buffered 2% lidocaine with 1:80,000 adrenaline, the second group (control group) will undergo dental extraction after receiving non-buffered 2% lidocaine with 1:80,000 adrenaline. The outcome variables include pain during injection, onset of anesthesia and effectiveness of anesthesia on buffered and non-buffered group.
- Conditions
- Anesthesia, Local
- Being tested
- sodium bicarbonate 8.4%, 2%lidocaine with 1:80.000 epinphrine, Mixing pen (onset buffering system)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonate 8.4%Drug
mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)
2%lidocaine with 1:80.000 epinphrineDrug
injection
Mixing pen (onset buffering system)Device
Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient
| Study group | Role | What they receive |
|---|---|---|
| Buffered Local anesthesia | Active comparator | Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine Receives: Drug: sodium bicarbonate 8.4%; Device: Mixing pen (onset buffering system) |
| Non Buffered Local anesthesia | Placebo comparator | 2%lidocaine with 1:80.000 epinphrine. Receives: Drug: 2%lidocaine with 1:80.000 epinphrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during Injection
Numerical rating scale from 0-10 that (0) mean no pain and (10) worst pain
Measured: Immediately after Injection
Onset of anesthesia
probing marginal gingiva
Measured: 30 seconds to 90 seconds
Effectiveness of anesthesia
number of carpules used
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Feb 2021 (estimated)
- Primary completion22 May 2021 (estimated)
- Study completion22 Aug 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 University of BaghdadThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danny Benjamin, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773236
- Sponsor's protocol ID
- 206120
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Buffered Local Anesthesia in Dental Extraction: A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT04773236
- Acronym / sponsor ID
- 206120
- Conditions
- Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 22 Feb 2021 (estimated)
- Primary completion
- 22 May 2021 (estimated)
- Study completion
- 22 Aug 2021 (estimated)
- First posted
- 26 Feb 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.
To compare pain during injection, onset of anesthesia and effectiveness of anesthesia using buffered versus non- buffered 2% lidocaine with 1:80,000 adrenaline in dental extraction.
Detailed description
The investigators will conduct a prospective, randomized, single-blinded study, the sample will include 100 patients (extraction) who need dental extraction of upper teeth (premolar and molar teeth). The predictor variable is the use of buffered 2% lidocaine with 1:80,000 adrenaline and non-buffered 2% lidocaine with 1:80,000 adrenaline. The patients will be randomly assigned into two groups of 50 patients each using Microsoft Excel 2016; the first group (study group) will undergo dental extraction after receiving buffered 2% lidocaine with 1:80,000 adrenaline, the second group (control group) will undergo dental extraction after receiving non-buffered 2% lidocaine with 1:80,000 adrenaline. The outcome variables include pain during injection, onset of anesthesia and effectiveness of anesthesia on buffered and non-buffered group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buffered Local anesthesia | Active comparator | Drug: sodium bicarbonate 8.4%, Device: Mixing pen (onset buffering system)Sodium bicarbonate with 2% lidocaine and 1:80.000 epinphrine |
| Non Buffered Local anesthesia | Placebo comparator | Drug: 2%lidocaine with 1:80.000 epinphrine2%lidocaine with 1:80.000 epinphrine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Give written, informed consent (both the subject and the legal guardian).
- Be 18-65 years of age. 3.Be able to comprehend the visual analog scale (instructions given to ascertain this).
- 4.Be able to comprehend the verbal rating scale (instructions given to ascertain this).
- 5.upper premolars and molars extraction.
Key exclusion criteria (3 listed)
- Patient under 18 years.
- pregnant women.
- patient with uncontrolled systemic disease that are contraindicated for dental extraction. 4- patient taking medication that interfere with the assessment of local anesthetic such as narcotics and antidepressants .
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 |
|---|---|---|
| sodium bicarbonate 8.4%mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system) | Drug | Buffered Local anesthesia |
| 2%lidocaine with 1:80.000 epinphrineinjection | Drug | Non Buffered Local anesthesia |
| Mixing pen (onset buffering system)Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient | Device | Buffered Local anesthesia |
Primary outcome
Pain during Injection
Time frame: Immediately after Injection
Numerical rating scale from 0-10 that (0) mean no pain and (10) worst pain
Onset of anesthesia
Time frame: 30 seconds to 90 seconds
probing marginal gingiva
Effectiveness of anesthesia
Time frame: during procedure
number of carpules used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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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 Phase 4 study testing sodium bicarbonate 8.4%, 2%lidocaine with 1:80.000 epinphrine and Mixing pen (onset buffering system) in people with Anesthesia, Local, run by University of Baghdad.
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 26 Feb 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain during Injection (time frame: Immediately after Injection). 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 26 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.