Dentine HypersensitivityNCT06633627
Neurological Responses in Patients with Dentine Hypersensitivity
An observational study of Dentine Hypersensitivity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Recording of brain activity using electroencephalography (EEG)
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2024to 30 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Natalie Wong, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Alessia Dunn, 01142712550, alessia.dunn@nhs.net
Fiona Boissonade, BDS, PhD
About this study
Official title: Identification and Quantification of Neurological Responses in Patients with Dentine Hypersensitivity
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Recording of brain activity using electroencephalography (EEG)
- Keywords
- Electroencephalography, Dentine Hypersensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with dentine sensitivity Receives: Other: Recording of brain activity using electroencephalography (EEG) | |
| Control | Patients without dentine sensitivity Receives: Other: Recording of brain activity using electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start11 Oct 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Dentine HypersensitivityStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, HALEON
- Responsible party
- Sponsor
- Investigators
- Fiona Boissonade, BDS, PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633627
- Sponsor's protocol ID
- STH22405
- Other IDs
- 230613
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The summary protocol and results summary will be shared. No identifiable information from the participants will be shared.
Publications
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.
PubMed 11153921Rodd 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.
PubMed 11269734Rodd 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.
PubMed 12015218Rodd 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.
PubMed 16364087Biggs 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.
PubMed 17109831Bird 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.
PubMed 17210118Rodd HD, Boissonade FM, Day PF. Pulpal status of hypomineralized permanent molars. Pediatr Dent. 2007 Nov-Dec;29(6):514-20.
PubMed 18254423Morgan 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.
PubMed 19715741Kaewpitak 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.
PubMed 32058593Solis-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.
PubMed 35295531Azab 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.
PubMed 31860902Arvaneh 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.
PubMed 30662400Hu 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.
PubMed 29324076Schiff 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.
PubMed 8534380Addy, M., Dentine hypersensitivity: new perspectives on an old problem. International Dental Journal, 2002. 52(5): p. 367-375.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Quantification of Neurological Responses in Patients with Dentine Hypersensitivity
- ClinicalTrials.gov ID
- NCT06633627
- Acronym / sponsor ID
- STH22405
- Conditions
- Dentine Hypersensitivity
- Keywords
- Electroencephalography, Dentine Hypersensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, HALEON
- Study start
- 11 Oct 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 9 Oct 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Recording of brain activity using electroencephalography (EEG)Patients with dentine sensitivity |
| Control | – | Other: Recording of brain activity using electroencephalography (EEG)Patients without dentine sensitivity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| 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 | Other | Control, Experimental |
Primary outcome
Electroencephalography (EEG) responses to tooth stimulation
Time frame: 1 hour
EEG responses to tooth stimulation will be measured, and EEG responses will be compared between participants with and without sensitive teeth
1 secondary outcome
Correlation between Dentine hypersensitivity experience questionnaire (DHEQ) score and EEG responses
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 11153921Rodd 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.
- Background: PubMed 11269734Rodd 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.
- Background: PubMed 12015218Rodd 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.
- Background: PubMed 16364087Rodd 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.
- Background: PubMed 17109831Biggs 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.
- Background: PubMed 17210118Bird 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.
- Background: PubMed 18254423Rodd HD, Boissonade FM, Day PF. Pulpal status of hypomineralized permanent molars. Pediatr Dent. 2007 Nov-Dec;29(6):514-20.
- Background: PubMed 19715741Morgan 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.
- Background: PubMed 32058593Kaewpitak 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.
- Background: PubMed 35295531Solis-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.
- Background: PubMed 31860902Azab 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.
- Background: PubMed 30662400Arvaneh 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.
- Individual participant dataSharing planned: No. The summary protocol and results summary will be shared. No identifiable information from the participants will be shared.
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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.
Natalie Wong, PhD contact
Fiona Boissonade, BDS, PhD principal investigator
University of Sheffield
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 Dentine Hypersensitivity, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 9 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 9 Oct 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 Kingdom. 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 Fiona Boissonade, BDS, PhD (+441142159314, f.boissonade@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography (EEG) responses to tooth stimulation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06633627, which also lists 15 linked publications.
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 9 Oct 2024.