PainPhase 2NCT06538233
Pain After Buffered Vs Non Buffered Articaine
A Phase 2 study testing Buffered articaine and Non buffered articaine in people with Pain, run by Cleveland Dental Institute at 1 site in United States.
Trial summary
Pain after buffered versus non buffered articaine. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Buffered articaine and Non buffered articaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Jan 2025
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females, age- 18 to 60 yrs.
- Medically free.
- Need a dental treatment in the upper anterior region.
Who cannot join
- Periodontally affected teeth.
- Radiographic bone loss.
- Upnormal length of the teeth.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clevland Dental Institute
Cleveland, Ohio, 44128
Pavanpreet Kaur, Resident, 216-355-1155, p.kaur@cdiohio.org
About this study
Official title: A Comparison of Pain Response During Administration of Buffered Articaine Versus Non-buffered Articaine Local Anesthetics for Dental Treatment in Adult
Pain after buffered versus non buffered articaine.
- Conditions
- Pain
- Being tested
- Buffered articaine, Non buffered articaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buffered articaineDrug
Injecting buffered articaine in maxillary anterior region and evaluate pain response.
Non buffered articaineDrug
Injecting non buffered articaine in maxillary anterior region and evaluate pain response.
| Study group | Role | What they receive |
|---|---|---|
| Buffered articaine | Experimental | Not described Receives: Drug: Buffered articaine |
| non buffered articaine | Active comparator | Not described Receives: Drug: Non buffered articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rate Scale (NRS)
Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain .
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed H Khalifa, PhD, Study chair, Cleveland Dental InstituteWaleed Elmallah, PhD, Principal investigator, Cleveland Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538233
- Sponsor's protocol ID
- CDIOS00010
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pain Response During Administration of Buffered Articaine Versus Non-buffered Articaine Local Anesthetics for Dental Treatment in Adult
- ClinicalTrials.gov ID
- NCT06538233
- Acronym / sponsor ID
- CDIOS00010
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 5 Aug 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.
Pain after buffered versus non buffered articaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buffered articaine | Experimental | Drug: Buffered articaine |
| non buffered articaine | Active comparator | Drug: Non buffered articaine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females, age- 18 to 60 yrs.
- Medically free.
- Need a dental treatment in the upper anterior region.
Key exclusion criteria (3 listed)
- Periodontally affected teeth.
- Radiographic bone loss.
- Upnormal length of the teeth.
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 |
|---|---|---|
| Buffered articaineInjecting buffered articaine in maxillary anterior region and evaluate pain response. | Drug | Buffered articaine |
| Non buffered articaineInjecting non buffered articaine in maxillary anterior region and evaluate pain response. | Drug | non buffered articaine |
Primary outcome
Numerical Rate Scale (NRS)
Time frame: Immediate
Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- 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.
Ahmed H Khalifa, PhD study chair
Cleveland Dental Institute
Waleed Elmallah, PhD principal investigator
Cleveland Dental Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buffered articaine and Non buffered articaine in people with Pain, run by Cleveland Dental Institute at 1 site in United States.
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 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 5 Aug 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Pavanpreet Kaur, Resident (2163551155, p.kaur@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rate Scale (NRS) (time frame: Immediate). 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 5 Aug 2024.