Neurological Responses in Patients with Dentine Hypersensitivity

NCT06633627 | Recruiting

• 2 other identifiers: STH22405230613
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentine Hypersensitivity

Keywords

Electroencephalography; Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Secondary Outcomes (1)

• Correlation between Dentine hypersensitivity experience questionnaire (DHEQ) score and EEG responses

  30 minutes

Study Arms (2)

Experimental

Patients with dentine sensitivity

Other: Recording of brain activity using electroencephalography (EEG)

Control

Patients without dentine sensitivity

Other: Recording of brain activity using electroencephalography (EEG)

Interventions

Recording of brain activity using electroencephalography (EEG) OTHER

Electroencephalography (EEG) responses to sensitivity stimuli applied to the teeth in patients with and without dentine hypersensitivity will be compared

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults 18 years and older;
• Understands and is willing, able and likely to comply with all study procedures and restrictions;
• Accepts the form of the study and signs a declaration of informed consent;
• In good health (in the opinion of the clinical dental professional);
• 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.

You may not qualify if:

• Adults currently using maxillary or mandibular orthodontic appliances;
• Obvious signs of untreated caries, which in the opinion of the clinical dental professional, will affect the scientific validity of the study;
• Periodontal pocket depth ≥4mm in the anterior upper or lower sextants;
• Evidence of periodontitis.
• Have a history of seizures;
• Taking medications that affect brain responses;
• Experience damaged skin on the scalp due to cuts, psoriasis, eczema, or other conditions;
• Any participant who in the investigator's judgment will not comply with the study protocol;
• Any participant who has difficulties in adequate understanding of English.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator
• HALEON: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

RECRUITING

Related Publications (15)

• 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.

  PMID: 11153921 BACKGROUND

• 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.

  PMID: 11269734 BACKGROUND

• 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.

  PMID: 12015218 BACKGROUND

• 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.

  PMID: 16364087 BACKGROUND

• 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.

  PMID: 17109831 BACKGROUND

• 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.

  PMID: 17210118 BACKGROUND

• Rodd HD, Boissonade FM, Day PF. Pulpal status of hypomineralized permanent molars. Pediatr Dent. 2007 Nov-Dec;29(6):514-20.

  PMID: 18254423 BACKGROUND

• 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.

  PMID: 19715741 BACKGROUND

• 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.

  PMID: 32058593 BACKGROUND

• 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.

  PMID: 35295531 BACKGROUND

• 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.

  PMID: 31860902 BACKGROUND

• 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.

  PMID: 30662400 BACKGROUND

• 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.

  PMID: 29324076 BACKGROUND

• 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.

  PMID: 8534380 BACKGROUND

• Addy, M., Dentine hypersensitivity: new perspectives on an old problem. International Dental Journal, 2002. 52(5): p. 367-375.

  BACKGROUND

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Fiona Boissonade, BDS, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Boissonade, BDS, PhD

CONTACT

+441142159314; f.boissonade@sheffield.ac.uk

Natalie Wong, PhD

CONTACT

natalie.wong@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 9, 2024
• Study Start: October 11, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)