Neurological Responses in Patients with Dentine Hypersensitivity
NCT ID: NCT06633627
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2024-10-11
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Experimental
Patients with dentine sensitivity
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
Control
Patients without dentine sensitivity
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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University of Sheffield
OTHER
HALEON
INDUSTRY
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Fiona Boissonade, BDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Sheffield
Locations
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Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Fiona Boissonade, BDS, PhD
Role: backup
Mark Barber, BDS, MFDS RCS, PgCertEd, MPhil
Role: backup
Mahnaz Arvaneh, PhD
Role: backup
Natalie Wong, PhD
Role: backup
References
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Rodd HD, Boissonade FM. Substance P expression in human tooth pulp in relation to caries and pain experience. Eur J Oral Sci. 2000 Dec;108(6):467-74. doi: 10.1034/j.1600-0722.2000.00924.x.
Rodd HD, Boissonade FM. Innervation of human tooth pulp in relation to caries and dentition type. J Dent Res. 2001 Jan;80(1):389-93. doi: 10.1177/00220345010800011601.
Rodd HD, Boissonade FM. Comparative immunohistochemical analysis of the peptidergic innervation of human primary and permanent tooth pulp. Arch Oral Biol. 2002 May;47(5):375-85. doi: 10.1016/s0003-9969(02)00012-2.
Rodd HD, Boissonade FM. Immunocytochemical investigation of immune cells within human primary and permanent tooth pulp. Int J Paediatr Dent. 2006 Jan;16(1):2-9. doi: 10.1111/j.1365-263X.2006.00682.x.
Biggs JE, Yates JM, Loescher AR, Clayton NM, Boissonade FM, Robinson PP. Vanilloid receptor 1 (TRPV1) expression in lingual nerve neuromas from patients with or without symptoms of burning pain. Brain Res. 2007 Jan 5;1127(1):59-65. doi: 10.1016/j.brainres.2006.10.014. Epub 2006 Nov 14.
Bird EV, Robinson PP, Boissonade FM. Na(v)1.7 sodium channel expression in human lingual nerve neuromas. Arch Oral Biol. 2007 May;52(5):494-502. doi: 10.1016/j.archoralbio.2006.11.011. Epub 2007 Jan 8.
Rodd HD, Boissonade FM, Day PF. Pulpal status of hypomineralized permanent molars. Pediatr Dent. 2007 Nov-Dec;29(6):514-20.
Morgan CR, Bird EV, Robinson PP, Boissonade FM. TRPA1 expression in human lingual nerve neuromas in patients with and without symptoms of dysaesthesia. Neurosci Lett. 2009 Nov 13;465(2):189-93. doi: 10.1016/j.neulet.2009.08.055. Epub 2009 Aug 26.
Kaewpitak A, Bauer CS, Seward EP, Boissonade FM, Douglas CWI. Porphyromonas gingivalis lipopolysaccharide rapidly activates trigeminal sensory neurons and may contribute to pulpal pain. Int Endod J. 2020 Jun;53(6):846-858. doi: 10.1111/iej.13282. Epub 2020 Mar 23.
Solis-Castro OO, Wong N, Boissonade FM. Chemokines and Pain in the Trigeminal System. Front Pain Res (Lausanne). 2021 Jul 9;2:689314. doi: 10.3389/fpain.2021.689314. eCollection 2021.
Azab AM, Ahmadi H, Mihaylova L, Arvaneh M. Dynamic time warping-based transfer learning for improving common spatial patterns in brain-computer interface. J Neural Eng. 2020 Feb 18;17(1):016061. doi: 10.1088/1741-2552/ab64a0.
Arvaneh M, Robertson IH, Ward TE. A P300-Based Brain-Computer Interface for Improving Attention. Front Hum Neurosci. 2019 Jan 4;12:524. doi: 10.3389/fnhum.2018.00524. eCollection 2018.
Hu X, Racek AJ, Bellile E, Nascimento TD, Bender MC, Toback RL, Burnett D, Khatib L, McMahan R, Kovelman I, Ellwood RP, DaSilva AF. Brain Functional Changes before, during, and after Clinical Pain. J Dent Res. 2018 May;97(5):523-529. doi: 10.1177/0022034517750136. Epub 2018 Jan 11.
Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.
Addy, M., Dentine hypersensitivity: new perspectives on an old problem. International Dental Journal, 2002. 52(5): p. 367-375.
Other Identifiers
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230613
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STH22405
Identifier Type: -
Identifier Source: org_study_id
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