An observational study in Dentine Hypersensitivity, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational
Dentine hypersensitivity (also known as sensitive teeth) is a common dental condition in which the dentine, a layer of sensitive hard tissue under the enamel of the teeth, becomes exposed making the teeth sensitive to stimuli, such as hot and cold. It poses a significant challenge for clinicians and affects patients' quality of life.
The overall aim of the study is to understand if a way of measuring brain activity (electroencephalography [EEG]) shows a response to tooth stimulation, and see how these responses may be different in patients with dentine sensitivity.
EEG records brain signals and can provide information about how the brain processes painful stimuli. EEG recording is a non-evasive and painless procedure. It involves using a cap with small sensors called electrodes to pick up brain signals. During the EEG assessment appointment, brain signals will be recorded throughout the duration when cold temperatures and short bursts of air are applied to the tooth. Brain signals recorded during tooth stimulation from participants with and without dentine sensitivity will then be compared to explore if there are any differences.
The investigators hope that EEG responses could be helpful to objectively assess dentine sensitivity, further the understanding of brain processing of dental pain, and allow the comparison of the effectiveness of different treatment options in the future.
This information may help to improve treatments and the quality of life for patients with dentine sensitivity and potentially other types of dental pain.
Dentine hypersensitivity (DH) is a common dental condition that has been defined as a 'short, sharp pain arising from exposed dentine in response to stimuli typically thermal, evaporative, tactile, osmotic or chemical and which cannot be ascribed to any other form of dental defect or pathology'. Many DH interventions have been investigated over the last 60 years, but a lack of standardisation of pain measurement and objectivity of measures are major limitations for assessing the efficacy of products (or understanding why products fail). A potential solution to this problem is greater understanding of the pain propagation mechanism from controlled stimulus to objective, measurable markers of pain severity.
EEG (electroencephalography) is a non-invasive technique that measures the electrical activity of the brain using the electrodes placed on the scalp. EEG provides information about the brain's electrical activity over time, helping diagnose and understand certain neurological conditions. The investigators have carried out a number of studies using human dental pulp and other human tissue to further understand the mechanisms of pain including pulpal pain.
Evoked potentials are EEG responses to specific stimuli, such as light, sound or heat. Pain-evoked potentials from tooth pulp are evoked potentials specifically related to pain originating from the pulp of a tooth. This type of measurement records the brain's electrical response to a stimulus applied to a tooth, such as thermal stimuli. The resulting EEG recording can provide information about how the central nervous system processes painful stimuli, including the speed and magnitude of the response. It was hypothesised that EEG pain-evoked potentials, if generated and measured in a controlled and repeatable way, can potentially be used (in conjunction with other diagnostic methods) to objectively evaluate the severity of dentine sensitivity and compare the efficacy of different treatment options.
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
Browse Dentin Sensitivity studies →Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 214 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending routine restorative appointments at Charles Clifford Dental Hospital in Sheffield will be screened as potential eligible participants for the study by members of the direct clinical care team and informed about the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For patients with dentine sensitivity only (experimental group): self-reported sensitivity in at least 1 tooth; confirmed by response to air puff.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with dentine sensitivity
Other: Recording of brain activity using electroencephalography (EEG)
Patients without dentine sensitivity
Other: Recording of brain activity using electroencephalography (EEG)
Electroencephalography (EEG) responses to sensitivity stimuli applied to the teeth in patients with and without dentine hypersensitivity will be compared
Electroencephalography (EEG) responses to tooth stimulation
EEG responses to tooth stimulation will be measured, and EEG responses will be compared between participants with and without sensitive teeth
Time frame: 1 hour
Correlation between Dentine hypersensitivity experience questionnaire (DHEQ) score and EEG responses
Participants will be asked to complete the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ has 48 questions of which 34 comprise an impact scale. The DHEQ score is calculated as the sum of the scores from the questions, with a possible range of 34-238. A higher DHEQ score indicates that dentine hypersensitivity has a greater impact on the participant's quality of life. DHEQ score will be correlated with EEG responses recorded during tooth stimulation.
Time frame: 30 minutes
Plan to share: No — The summary protocol and results summary will be shared. No identifiable information from the participants will be shared.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheffield Teaching Hospitals NHS Foundation Trust →