NCT06633627 Neurological Responses in Patients with Dentine Hypersensitivity
| NCT ID | NCT06633627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Dentine Hypersensitivity |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-10-11 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults 18 years and older; 2. Understands and is willing, able and likely to comply with all study procedures and restrictions; 3. Accepts the form of the study and signs a declaration of informed consent; 4. In good health (in the opinion of the clinical dental professional); 5. A minimum of 10 teeth not including teeth with crowns or bridges from upper right 4 to upper left 4 and lower right 4 to lower left 4; For patients with dentine sensitivity only (experimental group): self-reported sensitivity in at least 1 tooth; confirmed by response to air puff. Exclusion Criteria: 1. Adults currently using maxillary or mandibular orthodontic appliances; 2. Obvious signs of untreated caries, which in the opinion of the clinical dental professional, will affect the scientific validity of the study; 3. Periodontal pocket depth ≥4mm in the anterior upper or lower sextants; 4. Evidence of periodontitis. 5. Have a history of seizures; 6. Taking medications that affect brain responses; 7. Experience damaged skin on the scalp due to cuts, psoriasis, eczema, or other conditions; 8. Any participant who in the investigator's judgment will not comply with the study protocol; 9. Any participant who has difficulties in adequate understanding of English.
Contact & Investigator
Fiona Boissonade, BDS, PhD
PRINCIPAL INVESTIGATOR
University of Sheffield
Frequently Asked Questions
Who can join the NCT06633627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dentine Hypersensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06633627 currently recruiting?
Yes, NCT06633627 is actively recruiting participants. Contact the research team at f.boissonade@sheffield.ac.uk for enrollment information.
Where is the NCT06633627 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT06633627 clinical trial?
NCT06633627 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The principal investigator is Fiona Boissonade, BDS, PhD at University of Sheffield. The trial plans to enroll 60 participants.