Acute PulpitisNCT06526572
Pain Measured by NRS and EEG in Acute Pulpitis
An observational study of Acute Pulpitis, run by Cleveland Dental Institute at 1 site in United States.
Trial summary
The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pulpitis
- What is being tested?
- Brain wave analysis using electroencephalography (EEG). and Numerical rate Scale (NRS)
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Jan 2025
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults male or females aged [18-50 years], Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings. They are medically free. They are willing and able to provide informed consent to participate in the study. They are able to communicate effectively in the language used for study procedures.
Who may be able to join
- Adults aged [18-50 years]. Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings.
- Demonstrates resistance to inferior alveolar nerve block (IANB). Willing and able to provide informed consent to participate in the study. Able to communicate effectively in the language used for study procedures.
Who cannot join
- Individuals with known neurological or psychiatric disorders affecting pain perception.
- Pregnant individuals or those breastfeeding at the time of the study. History of severe allergies or adverse reactions to local anesthetics or EEG gel.
- Presence of significant medical conditions that may contraindicate dental procedures or EEG recordings.
- Individuals taking medications that could significantly affect pain perception (e.g., strong analgesics, sedatives).
- Any contraindications for dental procedures or EEG recordings as determined by the study's dental and medical professionals.
- Inability to understand and follow study instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cleveland Dental Institute
Cleveland, Ohio, 44128
Ahmed A Hashem, Profesor, 440-502-1591, a.hashem@cdiohio.org
Waleed Elmallah, PhD, 2163336695, w.elmallah@cdiohio.org
About this study
Official title: Measuring Pain Perception in Patients With Symptomatic Acute Pulpitis and Resistant to Inferior Alveolar Nerve Block Using NRS and Brain Waves
The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB).
The study aims to achieve this by utilizing a dual approach that combines subjective self-reporting of pain intensity using the Numeric Rating Scale (NRS) with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).
Read more
By integrating these two methods, the study seeks to explore potential correlations between self-reported pain scores and neural responses recorded through EEG, providing insights into the pain experience of this specific patient population.
Ultimately, the goal of the study is to enhance the understanding of pain perception mechanisms in individuals with symptomatic acute pulpitis resistant to IANB and potentially guide the development of more effective and personalized pain management strategies for these patients.
- Conditions
- Acute Pulpitis
- Being tested
- Brain wave analysis using electroencephalography (EEG)., Numerical rate Scale (NRS)
- Keywords
- Acute pulpits, Electroencephalography, Numerical rate scale, Inferior Alveolar Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain wave analysis using electroencephalography (EEG).Diagnostic test
Asessment of pain with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).
Numerical rate Scale (NRS)Diagnostic test
Asessment of pain with the subjective numercal rate scale method (NRS
| Study group | Role | What they receive |
|---|---|---|
| symptomatic acute pulpitis | Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB) Receives: Diagnostic Test: Brain wave analysis using electroencephalography (EEG).; Diagnostic Test: Numerical rate Scale (NRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography (EEG)
Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection
Measured: 3 months
Numerical Rate Scale (NRS)
Measuring pain perception using NRS (Scale 0-10 where 0 is no pain and 10 is the most unbearable pain) in patients with acute pulpitis and resistant to alveolar nerve block injection.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jul 2023
- 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 Acute PulpitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A hashem, PhD, Study director, CDI Centro Diagnostico Italiano S.p.A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526572
- Sponsor's protocol ID
- CDIENDO0007
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Pain Perception in Patients With Symptomatic Acute Pulpitis and Resistant to Inferior Alveolar Nerve Block Using NRS and Brain Waves
- ClinicalTrials.gov ID
- NCT06526572
- Acronym / sponsor ID
- CDIENDO0007
- Conditions
- Acute Pulpitis
- Keywords
- Acute pulpits, Electroencephalography, Numerical rate scale, Inferior Alveolar Nerve Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 30 Jul 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.
The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB).
The study aims to achieve this by utilizing a dual approach that combines subjective self-reporting of pain intensity using the Numeric Rating Scale (NRS) with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).
By integrating these two methods, the study seeks to explore potential correlations between self-reported pain scores and neural responses recorded through EEG, providing insights into the pain experience of this specific patient population.
Ultimately, the goal of the study is to enhance the understanding of pain perception mechanisms in individuals with symptomatic acute pulpitis resistant to IANB and potentially guide the development of more effective and personalized pain management strategies for these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic acute pulpitis | – | Diagnostic Test: Brain wave analysis using electroencephalography (EEG)., Diagnostic Test: Numerical rate Scale (NRS)Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults male or females aged [18-50 years], Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings. They are medically free. They are willing and able to provide informed consent to participate in the study. They are able to communicate effectively in the language used for study procedures.
Key inclusion criteria (2 listed)
- Adults aged [18-50 years]. Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings.
- Demonstrates resistance to inferior alveolar nerve block (IANB). Willing and able to provide informed consent to participate in the study. Able to communicate effectively in the language used for study procedures.
Key exclusion criteria (6 listed)
- Individuals with known neurological or psychiatric disorders affecting pain perception.
- Pregnant individuals or those breastfeeding at the time of the study. History of severe allergies or adverse reactions to local anesthetics or EEG gel.
- Presence of significant medical conditions that may contraindicate dental procedures or EEG recordings.
- Individuals taking medications that could significantly affect pain perception (e.g., strong analgesics, sedatives).
- Any contraindications for dental procedures or EEG recordings as determined by the study's dental and medical professionals.
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 |
|---|---|---|
| Brain wave analysis using electroencephalography (EEG).Asessment of pain with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG). | Diagnostic test | symptomatic acute pulpitis |
| Numerical rate Scale (NRS)Asessment of pain with the subjective numercal rate scale method (NRS | Diagnostic test | symptomatic acute pulpitis |
Primary outcome
Electroencephalography (EEG)
Time frame: 3 months
Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection
Numerical Rate Scale (NRS)
Time frame: 3 months
Measuring pain perception using NRS (Scale 0-10 where 0 is no pain and 10 is the most unbearable pain) in patients with acute pulpitis and resistant to alveolar nerve block injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Ahmed A hashem, PhD study director
CDI Centro Diagnostico Italiano S.p.A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulpitis, 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 2 inclusion and 6 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 31 Jul 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.
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 Ahmed I Basyoni (3612290038, a.basyoni@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) (time frame: 3 months). 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 31 Jul 2024.